Natera Inc (NTRA) 2025 Q2 法說會逐字稿

Hello. Welcome to Natera's 2025 second-quarter financial results conference call.

你好。歡迎參加 Natera 2025 年第二季財務業績電話會議。

(Operator Instructions) As a reminder, this conference call is being recorded today, August 7, 2025.

（操作員指示）提醒一下，本次電話會議將於今天（2025 年 8 月 7 日）進行錄音。

I would now like to turn the conference call over to Michael Brophy, Chief Financial Officer. Please go ahead.

現在，我想將電話會議交給財務長 Michael Brophy。請繼續。

Thanks, operator. Good afternoon. Thank you for joining our conference call to discuss the results of our second quarter of 2025.

謝謝，接線生。午安.感謝您參加我們的電話會議，討論我們 2025 年第二季的業績。

On the line, I'm joined by Steve Chapman, our CEO; Solomon Moshkevich, President, Clinical Diagnostics; and Alex Aleshin, General Manager of Oncology and our Chief Medical Officer.

在線上，與我一起通話的還有我們的執行長史蒂夫·查普曼 (Steve Chapman)、臨床診斷總裁所羅門·莫什克維奇 (Solomon Moshkevich) 以及腫瘤科總經理兼首席醫療官亞歷克斯·阿列辛 (Alex Aleshin)。

Today's conference call is being broadcast live via webcast.

今天的電話會議透過網路直播。

We will be referring to a slide presentation that has been posted to investor.natera.com. A replay of the call will also be posted to our IR site, as soon as it's available.

我們將參考已發佈在 investor.natera.com 上的幻燈片簡報。電話會議的重播也將盡快發佈到我們的投資者關係 (IR) 網站上。

Starting on slide 2, during the course of this conference call, we will make forward-looking statements regarding future events and our anticipated future performance such as our operational and financial outlook and projections, our assumptions for that outlook, market size, partnerships, clinical studies, and expected results, opportunities and strategies and expectations for various current and future products, including product capabilities, expected release dates, reimbursement coverage, and related effects on our financial and operating results.

從第 2 張投影片開始，在本次電話會議期間，我們將對未來事件和預期的未來業績做出前瞻性陳述，例如我們的營運和財務前景和預測、我們對該前景的假設、市場規模、合作夥伴關係、臨床研究和預期結果、機會和策略以及對各種當前和未來產品的期望，包括產品功能、預期發布日期、報銷範圍以及對我們的財務影響的影響。

We caution you that such statements reflect our best judgment based on factors currently known to us and that actual events or results could differ materially. Please refer to the documents we file from time to time with the SEC, including our most recent Form 10-K or 10-Q and the Form 8-K filed with today's press release. Those documents identify important risks and other factors that may cause our actual results to differ materially from those contained in or suggested by the forward-looking statements.

我們提醒您，此類聲明反映了我們根據目前已知的因素做出的最佳判斷，實際事件或結果可能存在重大差異。請參閱我們不時向美國證券交易委員會提交的文件，包括我們最新的 10-K 表或 10-Q 表以及與今天的新聞稿一起提交的 8-K 表。這些文件確定了可能導致我們的實際結果與前瞻性陳述中包含或暗示的結果有重大差異的重要風險和其他因素。

Forward-looking statements made during the call are made as of today, August 7, 2025. If this call is replayed or reviewed after today, the information presented during the call may not contain current or accurate information. Natera disclaims any obligation to update or revise any forward-looking statements.

電話會議期間所做的前瞻性陳述截至今天（2025 年 8 月 7 日）。如果在今天之後重播或審查此通話，通話期間提供的資訊可能不包含最新或準確的資訊。Natera 不承擔更新或修改任何前瞻性聲明的義務。

We will provide guidance on today's call. But we'll not provide any further guidance or updates on our performance during the quarter unless we do so in a public forum. We will quote a number of numeric or growth changes as we discuss our financial performance. unless otherwise noted, each such reference represents a year-on-year comparison.

我們將在今天的電話會議上提供指導。但除非我們在公開論壇上這樣做，否則我們不會提供有關本季業績的任何進一步指導或更新。在討論財務表現時，我們將引用一些數字或成長變化。除非另有說明，否則每個此類引用都代表同比比較。

Now, I'd like to turn the call over to Steve. Steve?

現在，我想把電話轉給史蒂夫。史蒂夫？

Thanks, Mike. Let's get to the highlights on the next slide.

謝謝，麥克。讓我們看看下一張投影片上的重點內容。

We had a phenomenal quarter. We generated $547 million in revenue, which is 32% growth over Q2 of last year. Ex-revenue true-ups, our revenues grew 34% year on year.

我們度過了一個非凡的季度。我們創造了 5.47 億美元的收入，比去年第二季成長了 32%。扣除實際收入後，我們的收入年增 34%。

We had a very strong volume quarter as well, which included strong growth across the product portfolio and an all-time record for Signatera. We processed 189,000 oncology tests in the quarter, which represents nearly 20,000 units of growth compared to our first quarter of this year. 20,000 sequential growth unit significantly beats our previous growth record and is a new milestone for the company. Part of this growth acceleration was driven by a significant increase in new patient starts, which was double our previous quarterly record.

本季我們的銷售量也十分強勁，包括整個產品組合的強勁成長以及 Signatera 創下的歷史最高紀錄。本季我們處理了 189,000 次腫瘤學測試，與今年第一季相比成長了近 20,000 個單位。 20,000 個連續成長單位大大超過了我們先前的成長記錄，對於公司來說是一個新的里程碑。這一成長加速的部分原因是新患者數量的大幅增加，這一數字是我們上一季記錄的兩倍。

Gross margin ticked up again in Q2 at 63.4% compared to approximately 59% this time last year. Ex-true-ups, gross margins were consistent sequentially versus Q1 due to strong ASPs, despite the fact that Signatera COGS actually went up meaningfully because we ran so many exomes for first-time patients, which, of course, is very good news.

第二季毛利率再次上升至 63.4%，去年同期約為 59%。除實際成長外，由於平均銷售價格強勁，毛利率與第一季度相比保持了連續一致，儘管由於我們為首次就診患者運行瞭如此多的外顯子組，Signatera 的 COGS 實際上大幅上升，這當然是個非常好的消息。

Given all that momentum, we are in a position to level up the financial guide for the year. We are raising the revenue guidance by $80 million at the midpoint. We now expect revenues in the range of $2.20 billion to $2.1 billion, which is a full reset of the prior revenue range.

鑑於所有這些勢頭，我們有能力提高今年的財務指南。我們將收入預期中位數提高了 8000 萬美元。我們現在預計收入將在 22 億美元至 21 億美元之間，這與先前的收入範圍完全一致。

We are raising the gross margin guide to 61% to 64% in recognition of the gross margin performance we saw in the first half, which still accounts for factors like growth in new patients in the second half.

我們將毛利率指引上調至 61% 至 64%，以表彰我們上半年看到的毛利率表現，但這仍然考慮了下半年新患者成長等因素。

We are not increasing our operating expenses, which were remaining flat versus the prior guide as we get scale in the business despite being the full investment mode for the future.

我們不會增加營運費用，儘管我們處於對未來的全面投資模式，但由於業務規模擴大，營運費用與先前的指導相比保持不變。

In addition to the financials, we have a full slate of new data and product updates to discuss today. We are particularly excited to launch Fetal Focus, a new NIPT for inherited conditions that leverages our proprietary SNP-based method for NIPT.

除了財務數據外，我們今天還有一系列新數據和產品更新要討論。我們特別高興地推出 Fetal Focus，這是一種針對遺傳疾病的新型 NIPT，它利用我們專有的基於 SNP 的 NIPT 方法。

We've never had better momentum in Organ Health. The Prospera data that we'll talk about today, I think, shows the path we're on to transforming care for organ transplant patients.

我們在器官健康領域從未有過如此好的動能。我認為，我們今天要討論的 Prospera 數據展示了我們改變器官移植患者護理的方式。

In Oncology, the data pipeline continues to grow. We're going to take some time on the call today to do a deeper dive on our strong and broad data across breast cancer and new data in GI cancers beyond CRC.

在腫瘤學領域，數據管道不斷成長。今天我們將花一些時間在電話會議上深入探討我們在乳癌方面的強大而廣泛的數據以及 CRC 以外的胃腸道癌症的新數據。

Finally, we've been working in the background on the next major wave of innovation at Natera. First, we'll go over the rapid progress we're making on early cancer detection, where we're gearing up for a big read-out of the prospective colonoscopy match PRESIDE trial for advanced adenoma late this fall. Next, we will introduce Natera's AI-based foundation models, which are being used to develop new diagnostic biomarkers, molecular therapeutics, and speed clinical trials.

最後，我們一直在幕後努力推動 Natera 的下一波重大創新浪潮。首先，我們將回顧我們在早期癌症檢測方面取得的快速進展，我們正準備在今年秋末對晚期腺瘤的前瞻性大腸鏡檢查匹配 PRESIDE 試驗進行大規模讀取。接下來，我們將介紹 Natera 基於 AI 的基礎模型，這些模型正在用於開發新的診斷生物標記、分子療法和加速臨床試驗。

Okay. Let's get into some of the business trends on the next slide. The first slide just shows our Q2 volume progression over prior years. This was another great quarter for us across the board as we were able to grow significantly against the Q2 2024 comparable that was elevated due to a sudden influx of Invitae units. Signatera was phenomenal with growth records in both sequential growth and new patient starts.

好的。下一張投影片讓我們了解一些商業趨勢。第一張投影片只是顯示了我們第二季的銷售量與前幾年相比的變化。對我們來說，這又是一個全面出色的季度，因為我們能夠與 2024 年第二季度相比實現顯著增長，而這一增長是由於 Invitae 單位的突然湧入而提升的。Signatera 在連續增長和新患者開始數量方面均取得了驚人的增長記錄。

In Women's Health, we saw our second best volume quarter ever coming off what was a blowout Q1 number. We saw the same Q2 seasonality trends that we always see, given our large base of existing customers but we continue to blunt that impact by winning new accounts.

在女性健康領域，我們迎來了有史以來第二好的季度銷售，得益於第一季銷售的大幅成長。鑑於我們現有的客戶群龐大，我們看到了與以往相同的第二季季節性趨勢，但我們繼續透過贏得新客戶來減輕這種影響。

Our Organ Health products have been on a tear this year, with major new account wins driving growth on the back of some very strong clinical data. There's more new data that we're going to talk about today, which I think sets us up very well for the future in that space.

我們的器官健康產品今年表現優異，憑藉一些非常強勁的臨床數據，大量新客戶贏得市場，推動了成長。今天我們將討論更多新數據，我認為這些數據為我們在該領域的未來奠定了良好的基礎。

We also recently exited our legacy (inaudible) business, which was contributing to our volume numbers historically.

我們最近也退出了我們的傳統（聽不清楚）業務，該業務在歷史上對我們的銷售做出了貢獻。

The next slide shows our Signatera clinical units over time. This quarter, we grew by 20,000 growth units versus our average over the prior four quarters of about 13,000 per quarter. This overperformance was a result of a wave of new patient starts, driven by the compelling data we generated in the last year.

下一張投影片展示了我們 Signatera 臨床單位隨時間的變化。本季度，我們的成長單位數增加了 20,000 個，而前四個季度的平均成長單位數為每季約 13,000 個。這種超額表現是由於我們去年產生的令人信服的數據推動了一波新患者開始就診的結果。

Growth in new patient starts was about 3 times higher than our quarterly average and about 2 times higher than the previous record quarter. As we said before, Signatera quarterly volumes could fluctuate. So I don't think 20,000 growth units is a new normal. But clearly, this strong growth is a great sign.

新患者數量的成長比我們的季度平均值高出約 3 倍，比上一季的高出約 2 倍。正如我們之前所說，Signatera 季度交易量可能會波動。所以我不認為 20,000 個成長單位是新常態。但顯然，這種強勁的成長是一個好兆頭。

Historically, a lot of our growth has come from colorectal cancer, breast cancer, and IO monitoring. And again, we saw very strong growth in these areas.

從歷史上看，我們的很大一部分成長來自於大腸癌、乳癌和腸內監測。我們再次看到這些領域的強勁成長。

In addition, we're now seeing broader adoption in many other tumor types as physicians really start to generalize the use of Signatera in their clinics, which is helping drive volume growth but also creates a large revenue opportunity.

此外，隨著醫生開始在診所中推廣使用 Signatera，我們現在看到該藥物在許多其他腫瘤類型中的應用越來越廣泛，這不僅有助於推動銷售成長，還創造了巨大的收入機會。

We're in the process of seeking Medicare reimbursement for this longer tail of cancers. Based on our current growth trajectory, gaining Medicare coverage for these non-covered histologies over the next few years should be worth approximately $250 million to $300 million in annual revenue and gross profit, further contributing to the financial sustainability of our growth strategy and supporting our path to a $2,000 ASP.

我們正在尋求醫療保險對這類長尾癌症的補償。根據我們目前的成長軌跡，在未來幾年內獲得這些未涵蓋組織學的醫療保險覆蓋應該價值約 2.5 億至 3 億美元的年收入和毛利，進一步促進我們成長策略的財務可持續性並支持我們實現 2,000 美元的 ASP。

We're in an excellent position to achieve this, given the significant amount of data we generated so far. And of course, we have over 100 clinical trials underway, many of which support these types of initiatives.

考慮到我們迄今為止產生的大量數據，我們完全有能力實現這一目標。當然，我們正在進行 100 多項臨床試驗，其中許多都支持此類措施。

I mentioned we grew revenues 34% organically year over year. You'll recall, Q2 of last year was a very strong quarter for us so I'm pleased to see the strong growth numbers over some very tough 2024 comparables.

我提到過，我們的營收年增了 34%。您會記得，去年第二季度對我們來說是一個非常強勁的季度，因此我很高興看到與 2024 年一些非常艱難的可比較數據相比，強勁的成長數據。

We had about $45 million in revenue true-ups this quarter as we continue to improve reimbursement for covered services. Sequentially over Q1, we grew revenues 9% overall and 7% organically. We've already covered the very strong volume levers driving this growth but we also saw excellent ASPs across the board.

由於我們繼續提高承保服務的報銷水平，本季度我們的收入實際增長了約 4500 萬美元。與第一季相比，我們的整體營收成長了 9%，有機收入成長了 7%。我們已經介紹了推動這一成長的強勁銷售槓桿，但我們也看到了全面出色的平均售價。

The next slide shows our gross margin traction over time. We posted another strong gross margin quarter in Q2. Stripping out the revenue true-ups, we were still able to generate gross margin steady with Q1 despite the big step-up in exome volumes this quarter.

下一張投影片展示了我們的毛利率隨時間的變化。我們在第二季再次取得了強勁的毛利率。除去收入實際成長，儘管本季外顯子組數量大幅增加，我們仍然能夠在第一季保持穩定的毛利率。

We drove that with better ASPs for Signatera, which is now roughly at 1,175, along with steady results in ASPs in Panorama, Horizon, and growth in the Prospera ASP.

我們推動了 Signatera 平均售價的提高，目前約為 1,175，同時 Panorama、Horizo​​n 平均售價也保持穩定，Prospera 平均售價也持續成長。

We were also very pleased to see continued revenue true-ups in the quarter, which means that cash collections exceeded our prior history. I think the speed at which we're converting receivables into cash is one of the most promising business trends we're seeing. And DSOs are now down to 57 days, which is a record for the company by a wide margin.

我們也很高興看到本季收入持續上升，這意味著現金收入超過了我們之前的歷史記錄。我認為我們將應收帳款轉換為現金的速度是我們所看到的最有前景的商業趨勢之一。目前，DSO 已降至 57 天，創下了該公司的最高紀錄。

All of these trends allow us to generate cash while aggressively investing for future growth. Although this slide shows how much progress we made over the last two years, I really think we are just scratching the surface of the margin improvements we can achieve.

所有這些趨勢使我們能夠產生現金，同時積極投資於未來的成長。儘管這張投影片展示了我們在過去兩年中取得的巨大進步，但我真的認為我們只是觸及了我們能夠實現的利潤率提升的表面。

We think about margin expansion opportunities across four primary vectors: continued execution of revenue cycle operations; expanded coverage for products, including Signatera; further COGS reductions; and AI-driven efficiencies.

我們從四個主要方面考慮利潤率擴張機會：繼續執行收入週期營運；擴大包括 Signatera 在內的產品覆蓋範圍；進一步降低 COGS；以及人工智慧驅動的效率。

First, we embarked on a major investment in our revenue cycle operations, leadership systems and staffing in the fall of 2022, and that project has yielded significant returns for the company. Our team sees ample additional opportunities to continue to make improvements, which could drive ASPs higher. We've seen good results so far this year.

首先，我們在 2022 年秋季對收入週期營運、領導系統和人員配置進行了重大投資，該專案為該公司帶來了豐厚的回報。我們的團隊看到了繼續改進的大量額外機會，這可能會推高平均售價。今年到目前為止我們已經看到了良好的成果。

One example is on appeals. Historically, it's very difficult to do an individualized appeal for each denial. But as our systems improve and we invest, we're building these types of capabilities that will allow us to get paid on a higher percent of cases.

其中一個例子就是上訴。從歷史上看，針對每次拒絕進行個別上訴是非常困難的。但隨著我們的系統的改進和我們的投資，我們正在建立這些類型的功能，這將使我們能夠在更高比例的案件中獲得報酬。

Second is expanding coverage for our products. We mentioned on the last call that we think $2,000 is an achievable ASP for Signatera. I mentioned the new opportunity in front of us to drive reimbursement in a number of additional tumor types. I'll stress that this opportunity has gotten much larger over the last couple of quarters as our volumes in non-covered tumor types have grown. We expect to have several additional coverage decisions within the next 12 months.

第二是擴大產品覆蓋範圍。我們在上次電話會議上提到，我們認為 2,000 美元是 Signatera 可以實現的平均銷售價格。我提到了我們面前的新機遇，即推動多種其他腫瘤類型的報銷。我要強調的是，隨著我們未涵蓋的腫瘤類型數量不斷增長，這個機會在過去幾季中變得更大。我們預計在未來 12 個月內將做出幾個額外的核保決定。

We continue to see positive early signs in biomarker states, which is still at the very early stages, Still have opportunity with Medicare Advantage execution.

我們繼續看到生物標誌狀態的積極早期跡象，這仍處於非常早期的階段，在醫療保險優勢計劃的執行方面仍有機會。

Outside of Oncology, we still have major opportunities for improved coverage with expanded carrier screening, 22q, and broader coverage for our Organ Health products, which could all drive ASP improvements.

在腫瘤學之外，我們仍然有很大機會透過擴大攜帶者篩檢、22q 和器官健康產品的更廣泛覆蓋來提高覆蓋率，這些都可以推動 ASP 的改善。

The third area of improvement on margins is by cutting costs. One of the constants for us over the last decade is our commitment to investing in R&D projects that reduced cost of goods sold for new tests that we launch. This tends to have a relatively lower technical risk compared to new cross innovation and deliver high returns. We now have a full suite of COGS case projects we're initiating and some that are getting close to launch.

提高利潤率的第三個途徑是削減成本。過去十年來，我們始終堅持的一點就是致力於投資研發項目，以降低我們推出的新測試的銷售成本。與新的交叉創新相比，這往往具有相對較低的技術風險並能帶來高回報。我們現在有一整套正在啟動的 COGS 案例項目，其中一些項目即將啟動。

Finally, we're going to spend some time later on the call on the investments we're making in artificial intelligence. Well, there are some very exciting steps we're taking in [AI-teeled] innovation, there's a whole range of areas in the business where AI is already having an impact and allowing us to scale our volumes without a one-for-one increase in headcount.

最後，我們稍後會花一些時間討論我們在人工智慧領域的投資。嗯，我們在人工智慧創新方面邁出了一些非常令人興奮的步伐，人工智慧已經對許多業務領域產生了影響，讓我們能夠在不增加員工人數的情況下擴大業務量。

Many of these opportunities hit COGS as well as OpEx, and we expect to see some significant savings from this over time.

其中許多機會都會影響銷貨成本 (COGS) 和營運支出 (OpEx)，我們預計隨著時間的推移，將從中節省大量成本。

So in summary, we have several very [concrete] ways that we can increase the margin. Now, not all of these are under our direct control and the path won't always be linear. But it's great that we have these opportunities that we're executing across.

總而言之，我們有幾種非常具體的方法來增加利潤。現在，並非所有這些都在我們的直接控制之下，路徑並不總是線性的。但我們很高興能擁有這些正在實施的機會。

On the next slide, as I mentioned at the top of the call, we're holding OpEx steady, even as we raised top-line revenue guidance by $80 million. So we're getting scale even as we keep our foot on the gas with growth investments.

在下一張投影片中，正如我在電話會議開始時提到的那樣，即使我們將營收預期提高了 8000 萬美元，我們仍保持營運支出穩定。因此，即使我們加強對成長的投資力度，我們仍在不斷擴大規模。

We think these growth and margin expansion opportunities clearly warrant the investment required to deliver them. And this slide gives some additional color on where the incremental investments in 2025 are going.

我們認為，這些成長和利潤擴大機會顯然值得為實現這些機會所需的投資。這張投影片進一步說明了 2025 年增量投資的去向。

To be clear, the vast majority of the OpEx increase in 2025 is not yet driving revenue, either because it's pointed at a longer-term project like gaining reimbursement for uncovered services or completing a major clinical trial or delivering on new product launches or because our commercial hires are just coming on board and are not yet productive.

需要明確的是，2025 年營運支出成長的絕大部分尚未帶來收入，要么是因為它是針對長期項目，例如獲得未涵蓋服務的報銷或完成重大臨床試驗或推出新產品，要么是因為我們的商業僱員剛剛加入，尚未產生生產力。

I'll follow up on that example of commercial hires. We've recently expanded our commercial footprint, primarily in Oncology. We added these additional Oncology reps. We expect to start seeing meaningful contributions from these new people late this year and early next year.

我將繼續關注商業僱傭的這個例子。我們最近擴大了商業足跡，主要在腫瘤學領域。我們增加了這些額外的腫瘤學代表。我們期望在今年年底和明年年初開始看到這些新人做出有意義的貢獻。

As with a lot of these investments, there's a slingshot effect where they're hitting the expense line this year, but they don't start to impact revenue and volume growth until about 6 to 12 months later. The strong growth we've seen, thus far, this year wasn't really driven by these new hires.

與許多此類投資一樣，它們會產生一種彈弓效應，即今年它們會影響支出線，但直到大約 6 到 12 個月後才會開始影響收入和銷售成長。到目前為止，我們今年看到的強勁成長並不是真正由這些新員工推動的。

In addition to the commercial team, we continue to invest in the success of the revenue cycle management. As we said earlier, investing in revenue cycle management is one of the primary opportunities we have for margin expansion. So this makes a lot of sense to pursue.

除了商業團隊之外，我們也持續投資於收入週期管理的成功。正如我們之前所說，投資收入周期管理是我們擴大利潤的主要機會之一。因此，追求這一目標非常有意義。

Once this team has scaled up and the optimal tools and systems are in place, we can get significant scale on top of this infrastructure. We've been moving quickly here, which includes many manual processes that can be automated, so we don't have to keep scaling at the same pace going forward.

一旦這個團隊擴大規模，並且最佳工具和系統到位，我們就可以在這個基礎設施的基礎上實現顯著的規模。我們在這裡進展迅速，其中包括許多可以自動化的手動流程，因此我們不必繼續以相同的速度擴展。

The forecast also includes a meaningful addition of AI-focused technical staff that we think is very promising. We've also shored up our ability to scale with more lab footprint in additional basic company infrastructure to accommodate our growth.

該預測還包括增加專注於人工智慧的技術人員，我們認為這是非常有前景的。我們還透過在額外的公司基礎設施中增加更多的實驗室空間來增強我們的擴展能力，以適應我們的成長。

The R&D incremental investment in 2025 is really driven by both the Oncology clinical trial expansion and investing into new MRD products. We think this is important because there's so much opportunity in MRD so we're continuing to expand our already vast set of meaningful clinical trials and efforts to change guidelines, accelerate adoption and gain coverage where we don't yet have it. Our pace of new product launches has also increased this year.

2025 年研發增量投資的真正驅動力是腫瘤臨床試驗擴展和新 MRD 產品的投資。我們認為這很重要，因為 MRD 中存在許多機會，因此我們將繼續擴大我們已經非常廣泛的有意義的臨床試驗，並努力改變指導方針，加速採用並在我們尚未涵蓋的領域獲得覆蓋。今年我們推出新產品的腳步也加快了。

Earlier this year, we launched Signatera genome. We have many other MRD-related opportunities we're working on that will be announced in the future. In addition, we're excited today to have announced another innovation within the prenatal product line with single gene NIPT.

今年早些時候，我們推出了Signatera基因組。我們正在進行許多其他與 MRD 相關的工作機會，並將在未來公佈。此外，我們今天很高興地宣布產前產品線的另一項創新，即單基因 NIPT。

Finally, we're continuing to make rapid progress on early cancer detection, which we now think has the potential to be a major opportunity for Natera. We've executed well on the PRESIDE trial, which now has about 3,500 patients enrolled that we intend to read out in late fall. We have also launched the FDA enabling FIND trial.

最後，我們在早期癌症檢測方面繼續取得快速進展，我們現在認為這有可能成為 Natera 的重大機會。我們在 PRESIDE 試驗中表現良好，目前已有約 3,500 名患者參與，我們計劃在秋末公佈結果。我們也啟動了 FDA 支持的 FIND 試驗。

We think ECB is a very significant opportunity for Natera, especially given the high ASPs that are now being established and the existing distribution footprint we can leverage.

我們認為 ECB 對 Natera 來說是一個非常重要的機會，特別是考慮到目前正在建立的高 ASP 和我們可以利用的現有分銷足跡。

Finally, we're investing in AI and AI-enabled technology, which we will outline on the call today, which we think could revolutionize care and make a big impact. We plan to stay nimble on our investment strategy throughout the rest of the year.

最後，我們正在投資人工智慧和人工智慧技術，我們將在今天的電話會議上概述這些技術，我們認為這些技術可能會徹底改變醫療保健並產生重大影響。我們計劃在今年剩餘時間內保持靈活的投資策略。

If we see a clear opportunity to deploy capital, we're going to do that while maintaining our commitment to generating cash later this year. Having said that, I think we're reasonably well positioned to hold OpEx in the current range as we continue to grow.

如果我們看到明顯的資本部署機會，我們就會這樣做，同時保持今年稍後產生現金的承諾。話雖如此，我認為隨著我們繼續發展，我們完全有能力將營運支出保持在當前範圍內。

With that, I'm very pleased to hand it over to Solomon. Solomon?

我很高興將它交給所羅門。所羅門？

Thanks, Steve.

謝謝，史蒂夫。

Let's start with the news from Women's Health, where we had an exciting launch of our new Fetal Focus NIPT for inherited conditions. Let me walk you through some of the background first on the clinical unmet need that we're addressing with this new test, how the test works and the exceptional performance that we're seeing from our clinical validation study called EXPAND.

讓我們從《女性健康》雜誌的新聞開始吧，我們令人興奮地推出了針對遺傳疾病的全新 Fetal Focus NIPT。首先，讓我向您介紹我們透過這項新測試解決的臨床未滿足需求的一些背景資訊、測試的工作原理以及我們在名為 EXPAND 的臨床驗證研究中看到的卓越性能。

Today, when a pregnant mother is identified as a carrier of a recessive gene like cystic fibrosis, for example. Medical guidelines recommend testing the biological father to assess the baby's risk of inheriting the effective gene from both parents.

如今，當孕婦被確診為囊性纖維化等隱性基因的攜帶者。醫學指南建議對親生父親進行檢測，以評估嬰兒從父母雙方遺傳有效基因的風險。

But in some cases, the father is not available for testing. So with the launch of this new test, if a pregnant mother has streamed positive on Natera's Horizon carrier screen for one of the five most commonly tested genes, the fetal focus test can directly assess the baby's risk of inheriting the genetic condition just from a maternal blood sample.

但在某些情況下，父親無法接受檢測。因此，隨著這項新測試的推出，如果孕婦在 Natera 的 Horizo​​n 攜帶者篩檢中對五種最常測試的基因之一呈陽性，則胎兒焦點測試可以直接從母親血液樣本中評估嬰兒遺傳該遺傳疾病的風險。

The test is validated to analyze five key genes, as you can see outlined on this slide. And it's backed by data from the EXPAND trial, a large prospective clinical trial that we've been running for nearly two years. I want to tell you more about the EXPAND trial.

該測試已驗證可分析五個關鍵基因，正如您在這張投影片上所看到的。它得到了 EXPAND 試驗數據的支持，這是我們進行的近兩年的一項大型前瞻性臨床試驗。我想告訴你更多有關 EXPAND 試驗的資訊。

So far, the study has enrolled about 1,300 participants from a diverse multiethnic population, including patients from leading academic centers and MFM clinics, as well as a decentralized trial arm that leverages Natera's nationwide base of over 1 million Horizon patients per year.

到目前為止，該研究已經招募了來自不同民族人群的約 1,300 名參與者，其中包括來自領先學術中心和 MFM 診所的患者，以及一個分散的試驗部門，該部門利用 Natera 每年在全國範圍內超過 100 萬 Horizo​​n 患者的基礎。

Because of this, Natera is uniquely positioned to enroll quickly into the trial. We see EXPAND a similar to the SMART study. in that it's designed to be the definitive trial in this test category with all positive and negative outcomes confirmed by diagnostic genetic testing, either prenatally or after birth. In the first milestone read-out of about 100 patients from EXPAND, the Fetal Focus test demonstrated 91% sensitivity to affected pregnancies, where the baby actually inherited the recessive genes from both parents.

正因為如此，Natera 具有獨特的優勢，可以快速參與試驗。我們認為 EXPAND 與 SMART 研究類似，因為它旨在成為此測試類別中的權威試驗，所有陽性和陰性結果均通過產前或出生後的診斷性基因檢測確認。在對 EXPAND 約 100 名患者進行的首次里程碑讀數中，胎兒焦點測試顯示對受影響妊娠的敏感性為 91%，其中嬰兒實際上從父母雙方遺傳了隱性基因。

And the test successfully identified all five affected cases with homozygous variants, which are particularly challenging to detect in sell-through DN

此測試成功識別出所有五例具有純合變異的受影響病例，這在直銷型糖尿病腎病變 (DN) 中檢測起來尤其困難

A. Fetal Focus uses Natera's proprietary LinkedSNP technology, which enhances detection of these challenging cases across diverse ethnic populations. These early results not only highlight the clinical accuracy of Fetal Focus, they underscore the real-world value of Natera's proprietary technology.

答：Fetal Focus 使用 Natera 專有的 LinkedSNP 技術，該技術可增強對不同種族族群中這些困難病例的檢測能力。這些早期結果不僅凸顯了 Fetal Focus 的臨床準確性，也強調了 Natera 專有技術的實際價值。

Together, the product launch and the clinical data strengthened Natera's leadership in women's reproductive health and it reinforces our commitment to being a trusted partner to OB/GYNs, endocrine specialists, and patients across the country.

該產品的發布和臨床數據共同加強了 Natera 在女性生殖健康領域的領導地位，並強化了我們致力於成為全國婦產科醫生、內分泌專家和患者值得信賴的合作夥伴的承諾。

Turning now to Organ Health, this quarter, we announced the publication of the PEDAL study in the American Journal of Transplantation. AJT is the highest impact transplant journal, which speaks to the importance and the rigor behind the study. PEDAL is a first of its kind, prospective multi-center trial evaluating how donor-derived cell-free DNA can help predict long-term outcomes after a rejection of a kidney transplant.

現在談談器官健康，本季度，我們宣佈在《美國移植雜誌》上發表 PEDAL 研究。AJT 是影響力最大的移植期刊，這說明了這項研究的重要性和嚴謹性。PEDAL 是第一個此類前瞻性多中心試驗，旨在評估捐贈者來源的無細胞 DNA 如何幫助預測腎臟移植排斥後的長期結果。

You can think about this as similar to immunotherapy monitoring in Oncology because it answers the question of whether the treatment is working or not after someone has been diagnosed with rejection. The PEDAL study enrolled 488 kidney transplant recipients from 28 participating US and international transplant centers over four years.

您可以將其視為類似於腫瘤學中的免疫療法監測，因為它回答了在某人被診斷出排斥後治療是否有效的問題。PEDAL 研究歷時四年，招募了 28 個美國和國際移植中心的 488 名腎臟移植接受者。

96 of those patients had biopsy-proven acute rejection and we're monitoring with Prospera during treatment every two weeks for eight weeks. And 66 of those patients had clinical outcomes recorded at the 12-month mark. So the findings showed that transplant patients whose donor DNA levels remained high, during and after treatment, did poorly with 97.5% having negative outcomes at the 12-month mark.

其中 96 名患者經活檢證實急性排斥反應，我們在治療期間每兩週使用 Prospera 進行一次監測，持續八週。其中 66 名患者在 12 個月時記錄了臨床結果。因此，研究結果表明，在治療期間和治療後，捐贈者 DNA 水平仍然較高的移植患者表現不佳，97.5% 的患者在 12 個月時出現負面結果。

By contrast, the patients, where Prospera levels dropped and stayed low, were 60 times more likely to experience positive long-term outcomes. This is the first clinical evidence showing that serial monitoring with Prospera can inform patient management during treatment for acute rejection, potentially enabling earlier interventions and more tailored care.

相比之下，Prospera 水平下降並保持在低水平的患者獲得長期積極結果的可能性高出 60 倍。這是第一個臨床證據，表明使用 Prospera 進行連續監測可以為急性排斥治療期間的患者管理提供信息，從而可能實現更早的干預和更有針對性的護理。

We've got an incredible feedback on the data and a steady quality. Doctors were really eager for this type of read-out. It took a long time to run the trial. We're very pleased with the results. This new use case for Prospera complements the existing utility in detecting rejection and surveillance. As you know, Medicare has recently released a draft LCD, updating its coverage policy for surveillance, which we also believe is positive news.

我們獲得了令人難以置信的數據回饋和穩定的品質。醫生確實渴望得到這種類型的讀數。這次試驗耗費了很久。我們對結果非常滿意。Prospera 的這個新用例補充了檢測拒絕和監視的現有實用性。如您所知，Medicare 最近發布了一份 LCD 草案，更新了其監測覆蓋政策，我們也認為這是個好消息。

Turning now to Oncology, we had several important events for Signatera in the past few months, continuing to fuel the adoption of this amazing technology. At ASCO, we presented interim results from the DARE trial, which has accrued over 400 early-stage breast cancer patients with HR-positive, HER2-negative disease. This trial is what we call a TOMR trial for treatment on molecular recurrence. TOMR has the potential to become the new frontline of metastatic treatment, where the recurrence is detected first by Signatera even though the scans are still negative.

現在談到腫瘤學，過去幾個月我們為 Signatera 舉辦了幾場重要活動，繼續推動這項驚人技術的採用。在 ASCO 上，我們展示了 DARE 試驗的中期結果，該試驗已累積招募了 400 多名 HR 陽性、HER2 陰性的早期乳癌患者。這項試驗就是我們所說的分子復發治療的 TOMR 試驗。TOMR 有可能成為轉移性治療的新前沿，即使掃描結果仍為陰性，Signatera 也能先檢測到復發。

The DARE study has been recruiting and randomizing patients since 2021 to either receive CDK4/6 inhibition at time of Signatera positivity versus continuing standard-of-care observation.

DARE 研究自 2021 年以來一直在招募和隨機分配患者，在 Signatera 呈陽性時接受 CDK4/6 抑制治療或繼續接受標準治療觀察。

There are three key takeaways from this read-out at ASCO. First, patients who test serially negative have extremely good outcomes, with over 99% remaining recurrence free. This reflects excellent test sensitivity.

ASCO 的這次報告有三個關鍵要點。首先，連續檢測呈陰性的患者預後極佳，超過 99% 的患者沒有復發。這體現了出色的測試靈敏度。

Second, the test is so sensitive that 73% of the recurrences detected were purely molecular with the reflex scans showing no evidence of disease. And 93% of those patients were then successfully randomized. So this is a major sign that the TOMR strategy is viable, unlike prior attempts that resulted in lower patient randomization rates.

其次，該測試非常敏感，檢測到的 73% 的複發純粹是分子問題，反射掃描未顯示任何疾病的證據。其中 93% 的患者成功隨機分組。因此，這是一個重要訊號，表明 TOMR 策略是可行的，不同於先前的嘗試導致患者隨機化率較低。

As a reminder, the other 27% of patients in (Operator Instructions) disease is detected on a scan, also stand to benefit from early detection and treatment of metastatic disease.

需要提醒的是，另外 27% 的患者在透過掃描發現（操作員指示）疾病時，也可以從轉移性疾病的早期發現和治療中受益。

Third, we saw a twofold higher ctDNA clearance rate in one of the trial arms, providing a promising signal that early treatment intervention can make a difference at this stage.

第三，我們發現其中一個試驗組的 ctDNA 清除率提高了一倍，這是一個有希望的信號，表明早期治療幹預可以在這個階段發揮作用。

So we look forward to further read-outs from the DARE trial and the doubling down on the TOMR strategy, with our partners from biopharma and academia in breast cancer and other cancer types.

因此，我們期待與來自乳癌和其他癌症類型的生物製藥和學術界的合作夥伴一起進一步了解 DARE 試驗的結果並加倍實施 TOMR 策略。

Turning now to the neoadjuvant setting of breast cancer, where we had several important announcements. Earlier in the quarter, we presented new data from the ISPY-2 trial, which showed again that patients who tested Signatera negative at baseline or at diagnosis had extremely good outcomes after treatment. Natera's multi-year collaboration with the ISPY-2 team has yielded many important insights and peer-reviewed publications, systematically studying hundreds of early-stage breast cancer patients and correlating Signatera dynamics with treatment response and long-term outcomes.

現在談談乳癌的新輔助治療，我們有幾個重要的公告。本季度早些時候，我們公佈了 ISPY-2 試驗的新數據，該數據再次表明，基線或診斷時 Signatera 檢測呈陰性的患者在治療後取得了非常好的效果。Natera 與 ISPY-2 團隊多年的合作產生了許多重要見解和同行評審的出版物，系統地研究了數百名早期乳癌患者，並將 Signatera 動態與治療反應和長期結果關聯起來。

So this insight about the great prognosis when the baseline sample is negative has triggered many doctors to ask whether those patients might safely avoid chemotherapy. And perhaps they can be treated just with endocrine therapy instead, which is much less toxic.

因此，當基線樣本為陰性時，預後良好，這項見解促使許多醫生詢問這些患者是否可以安全地避免化療。或許，他們只需接受毒性較小的內分泌療法即可得到治療。

So this approach is now being formally investigated in a new clinical trial led by ABCSG, which is the Austrian Breast and Colorectal Study group. The trial is called TEODOR. It randomizes patients who were Signatera negative at baseline to just receive endocrine therapy versus chemotherapy prior to surgery.

因此，這種方法目前正在由奧地利乳房和結直腸研究小組 ABCSG 領導的一項新臨床試驗中進行正式研究。這項試驗名為 TEODOR。此方法將基線時 Signatera 呈陰性的患者隨機分為兩組，一組接受內分泌治療，另一組在手術前接受化療。

The trial is open at 15 sites in Austria and it aims to recruit 250 patients. This is a great example of how strong biobank data generated over many years can lead to a randomized clinical trial that ultimately has a chance to be practice changing. Our plan is to replicate this strategy as much as possible.

該試驗在奧地利的 15 個地點開放，目標是招募 250 名患者。這是一個很好的例子，說明多年來產生的強大的生物庫數據如何能夠促成隨機臨床試驗，最終有機會改變實踐。我們的計劃是盡可能複製這一策略。

We've built up a significant clinical pipeline in breast cancer, which we believe is hard to replicate. To date, we have 18 peer-reviewed publications and by our count, presented over 60 abstracts at top medical meetings. We have broad Medicare coverage across the neoadjuvant, adjuvant, and surveillance settings. All of this sets the foundation for the next wave of randomized trials, many of which are currently underway and others still to be announced.

我們在乳癌領域建立了重要的臨床管線，我們認為這是難以複製的。迄今為止，我們已有 18 篇經過同行評審的出版物，並且據我們統計，在頂級醫學會議上發表了 60 多篇摘要。我們的醫療保險涵蓋範圍廣泛，涵蓋新輔助治療、輔助治療和監測治療。所有這些都為下一波隨機試驗奠定了基礎，其中許多試驗目前正在進行中，其他試驗尚待公佈。

To ultimately solidify Signatera and ctDNA monitoring as the new standard of care across all settings of this disease, we've invested heavily into the data generation strategy in breast cancer, having spent and budgeted over $150 million on (inaudible) child alone. This is going to be hard for others to replicate given the extent of the capital investment required.

為了最終鞏固 Signatera 和 ctDNA 監測作為該疾病所有環境中的新護理標準的地位，我們在乳腺癌數據生成策略上投入了大量資金，僅在（聽不清楚）兒童方面就已花費和預算超過 1.5 億美元。考慮到所需的資本投資規模，其他人將很難複製這種模式。

Now, turning to gastrointestinal cancers. The adoption of Signatera has obviously been strong, especially in colorectal cancer but it's now growing quickly in other GI malignancies, including pancreatic, liver and gastroesophageal. We had two strong peer-reviewed publications in GI over the past three months.

現在，我們來談談胃腸道癌症。Signatera 的採用率顯然很高，特別是在結直腸癌領域，但現在它在其他胃腸道惡性腫瘤（包括胰腺癌、肝癌和胃食道癌）中的應用也迅速增長。過去三個月，我們在 GI 上發表了兩篇強而有力的同行評審出版物。

In gastroesophageal, the PLAGAST study was published in Nature Communications, validating Signatera in the neoadjuvant and adjuvant settings. This study follows 62 patients with locally advanced gastric and GE junction cancers and show that patients who failed to clear their ctDNA during neoadjuvant therapy had very poor outcomes.

在胃食道癌領域，PLAGAST 研究發表在《自然通訊》雜誌上，驗證了 Signatera 在新輔助和輔助治療中的有效性。這項研究追蹤了 62 名局部晚期胃癌和胃食道連接處癌患者，結果表明，在新輔助治療期間未能清除 ctDNA 的患者的預後非常差。

Study concluded that those patients would likely benefit from a change in therapy after surgery instead of just continuing the same treatment, which is a common strategy today with perioperative chemo or immunotherapy.

研究得出的結論是，這些患者可能會受益於手術後的治療改變，而不是僅僅繼續相同的治療，這是當今圍手術期化療或免疫療法的常見策略。

Signatera also detected recurrence with a median lead time of six months ahead of imaging. Gastroesophageal cancer is a deadly disease with no good biomarkers, where Signatera has the potential to really improve patient management and outcomes.

Signatera 還能在成像前六個月的中位數提前時間內檢測到復發。胃食道癌是一種沒有良好生物標記的致命疾病，而 Signatera 有可能真正改善患者的管理和治療結果。

In liver cancer, also known as hepatocellular carcinoma, or HCC, we published a great paper in JCO Precision Oncology that followed 125 patients. Early-stage liver cancer can be treated with either surgical resection or with a liver transplant. And this study saw about half and half contribution. And contrary to esophageal cancer, there is a guideline recommended biomarker called AFP, or alpha-fetoprotein, that simply does not work very well.

對於肝癌（也稱為肝細胞癌或 HCC），我們在《JCO Precision Oncology》上發表了一篇很棒的論文，對 125 名患者進行了追蹤調查。早期肝癌可以透過手術切除或肝臟移植治療。而本研究中貢獻者的比例大約是一半。與食道癌相反，指南建議的生物標記是 AFP，即甲胎蛋白，但效果並不好。

So in this study, we showed that Signatera significantly outperformed AFP in detecting recurrence with approximately 2 times longitudinal sensitivity and 100% longitudinal specificity and with diagnostic lead times of up to 16.5 months. So we're getting positive feedback about this study and growing interest to use Signatera for recurrence monitoring in both resected and transplanted patients.

因此，在本研究中，我們表明 Signatera 在檢測復發方面明顯優於 AFP，其縱向敏感性約高出 2 倍，縱向特異性為 100%，診斷提前期長達 16.5 個月。因此，我們對這項研究的回饋非常積極，並且對使用 Signatera 對切除和移植患者進行復發監測的興趣日益濃厚。

Finally, looking forward, Q3 will be another important quarter for Signatera as we expect data read-outs from the IMvigor011 trial in bladder cancer and other studies.

最後，展望未來，第三季度將是 Signatera 的另一個重要季度，因為我們期待從膀胱癌和其他研究中讀取 IMvigor011 試驗的數據。

Now, I'd like to turn it over to Alex to discuss our roadmap in early cancer detection and some of the exciting foundation models that we're building to fuel the next wave of AI-based innovation. Alex?

現在，我想讓亞歷克斯討論我們在早期癌症檢測方面的路線圖，以及我們正在建立的一些令人興奮的基礎模型，以推動下一波基於人工智慧的創新。亞歷克斯？

Thanks, Solomon.

謝謝，所羅門。

We continue to make steady progress on our ECD program. We have now consented over 3,500 patients for our PRESIDE CRC study, which is a prospective average-risk coloscopy-matched trial. This study is being conducted in a manner to closely mirror our FDA-enabling find study to minimize the risk of performance degradation. We plan for the next read-out from the study in the second half of 2025, which will assess assay performance in over 100 advanced adenoma samples and 500 normal controls.

我們的 ECD 計劃繼續穩步推進。目前，我們已有超過 3,500 名患者同意參與 PRESIDE CRC 研究，這是一項前瞻性平均風險大腸鏡檢查配對試驗。這項研究的進行方式與我們 FDA 授權的發現研究非常相似，以最大限度地降低性能下降的風險。我們計劃在 2025 年下半年進行下一次研究讀數，以評估 100 多個晚期腺瘤樣本和 500 個正常對照組的檢測表現。

Additionally, we're excited to announce that DEFINE study has now started enrollment and is on track to prospectively accrue the necessary patients to enable our FDA read-out in 2027. We continue to face gave the program and remain disciplined in our investment.

此外，我們很高興地宣布，DEFINE 研究現已開始招募，並有望前瞻性地累積必要的患者，以便在 2027 年獲得 FDA 的讀數。我們將繼續執行該計劃，並在投資方面保持紀律。

We want to highlight that our investment in our ECD program is already baked in into our operating expenses.

我們想強調的是，我們對 ECD 計劃的投資已經計入我們的營運費用。

On the next slide, I want to highlight 1 of the most exciting areas this quarter as we continue our investment in our AI initiative, which we're deploying across the entire company to scale our operations, improve user experience, and drive scientific innovation.

在下一張投影片中，我想強調本季最令人興奮的領域之一，因為我們將繼續投資我們的人工智慧計劃，我們正在整個公司部署該計劃，以擴大我們的營運規模，改善用戶體驗，並推動科學創新。

On the operations side, for the entire history of the company, many roles have had to scale linearly with commercial volume. For the first time, we have an opportunity to change that relationship, with AI allowing us to scale more efficiently and open up additional operating leverage worth approximately $200 million in savings over time.

在營運方面，在公司的整個歷史中，許多職位都必須隨著商業量線性擴展。我們第一次有機會改變這種關係，人工智慧使我們能夠更有效地擴大規模，並隨著時間的推移創造額外的營運槓桿，節省約 2 億美元的成本。

On the US side, we're also building a whole new suite of AI-enabled user experience tools, which are intended to change the way we interact with physicians and patients.

在美國方面，我們也正在建立一整套全新的人工智慧使用者體驗工具，旨在改變我們與醫生和患者的互動方式。

Finally, we are leveraging AI to develop new algorithms that will power the next generation of diagnostics and clinical insights.

最後，我們正在利用人工智慧開發新的演算法，為下一代診斷和臨床洞察提供動力。

On this front, today, we're announcing our AI-based Discovery to care platform that is designed to support various stages of therapeutic development from early target discovery the clinical decision support. This consists of three components.

在這方面，今天，我們宣布推出基於人工智慧的發現到護理平台，旨在支援從早期目標發現到臨床決策支援的各個治療發展階段。它由三個部分組成。

The first is the genomic and clinical data foundation layer on which our models are trained. The second is the core model layer that powers discovery. And the third is the application layer that supports clinical decision-making as well as providing genomic insights. The foundation for this effort is built on a rapidly growing set of de-identified data from over 250,000 patients and over 1 million longitudinal time points, along with abstracted clinical data and information on drug treatment and outcomes.

第一層是基因組和臨床資料基礎層，我們的模型就是在此基礎上進行訓練的。第二層是支持發現的核心模型層。第三層是支持臨床決策並提供基因組洞察的應用層。這項工作的基礎是建立在來自超過 25 萬名患者和超過 100 萬個縱向時間點的快速增長的去識別數據集以及抽象的臨床數據和藥物治療和結果資訊之上。

Taken together, this comprises one of the largest multimodal longitudinal oncology data sets that has ever been created with over 1 billion parameters.

總的來說，這是迄今為止最大的多模式縱向腫瘤學資料集之一，其參數超過 10 億個。

Utilizing this dataset, we train a multimodal foundational model on our deidentified Signatera and Altera data to power our core AI platform. This supports several key use cases.

利用該資料集，我們在去識別的 Signatera 和 Altera 資料上訓練多模式基礎模型，為我們的核心 AI 平台提供支援。這支援幾個關鍵用例。

The first, Natera can create digital twins that can virtually simulate patients for treatment optimization as well as outcome prediction. This can help make therapy recommendations such as suggesting the next line of therapy and opportunities for treatment de-escalation. It can also better predict outcomes and can run virtual in-silico clinical trials in order to optimize study design and reduce clinical development risk.

首先，Natera 可以創建數位孿生，虛擬模擬患者，以優化治療並預測結果。這有助於提出治療建議，例如建議下一步治療和降低治療等級的機會。它還可以更好地預測結果，並可以運行虛擬電腦臨床試驗，以優化研究設計並降低臨床開發風險。

One recent pilot demonstrated that our algorithm can accurately recommend immune therapy, based on real-world EHR data; while another pilot show that it outperformed both TMB and standalone pathology-based metrics and predicting immunotherapy response.

最近的一項試點表明，我們的演算法可以根據真實的 EHR 數據準確地推薦免疫療法；而另一項試點表明，它優於 TMB 和獨立的基於病理學的指標並預測免疫療法反應。

Next, Natera's real-time clinical trial matching software leverages molecular and clinical data to improve patients and researchers' ability to match individuals to appropriate clinical trials. This capability uses LOMs to interpret eligibility criteria and unstructured clinical records, which holds the potential to improve enrollment efficiency, reduce screen failures and accelerate trial timelines.

接下來，Natera 的即時臨床試驗匹配軟體利用分子和臨床數據來提高患者和研究人員將個人與適當的臨床試驗配對的能力。此功能使用 LOM 來解釋資格標準和非結構化臨床記錄，有可能提高入組效率、減少篩檢失敗並加快試驗時間。

Finally, Natera has developed an immune therapy response prediction algorithm and a molecular therapeutics design model, which we'll review on the next slide. NeoPredict and NeoSelect are the first of many algorithms Natera has developed to predict immune therapy response and identify potential new antigenic mutations, respectively. This historically has been one of the most challenging computational problems.

最後，Natera 開發了一種免疫療法反應預測演算法和分子治療設計模型，我們將在下一張投影片中進行回顧。NeoPredict 和 NeoSelect 是 Natera 開發的眾多演算法中的第一個，分別用於預測免疫治療反應和識別潛在的新抗原突變。從歷史上看，這是最具挑戰性的計算問題之一。

Natera developed these algorithms by utilizing our foundational genomic large language model trained on our longitudinal genomic dataset and has allowed us to demonstrate market leadership in this space. The tumor neoantigen selection alliance or the Tesla database is a reference dataset for benchmarking neoantigen protection tools.

Natera 利用我們在縱向基因組資料集上訓練的基礎基因組大語言模型開發了這些演算法，並使我們能夠在該領域展示市場領導地位。腫瘤新抗原選擇聯盟或特斯拉資料庫是用於對新抗原保護工具進行基準測試的參考資料集。

We ran our NeoSelect algorithm against the Tesla database and our algorithm outperformed 25 established models and be the second place model by around a factor of two when identifying highly-prioritized neoantigens.

我們在特斯拉資料庫上運行了 NeoSelect 演算法，在識別高優先級新抗原時，我們的演算法優於 25 個現有模型，並且比第二名的模型高出約兩倍。

While we continue to optimize our prediction and selection algorithms, we believe that these capabilities have very exciting potential in many areas that could improve patient care. We look forward to providing future updates on this program at both academic conferences and in publications.

在我們繼續優化預測和選擇演算法的同時，我們相信這些功能在許多可以改善患者護理的領域中具有非常令人興奮的潛力。我們期待在學術會議和出版物上提供有關該計劃的未來更新。

Additionally, Natera has created the NeoPredict algorithm to identify patients or likely either responsive or resistant to immune therapy treatment. NeoPredict leverages the neoantigen prediction capabilities we just described to identify patients who are most likely to benefit from immune therapy.

此外，Natera 還創建了 NeoPredict 演算法來識別對免疫療法有反應或有抵抗力的患者。NeoPredict 利用我們剛剛描述的新抗原預測功能來識別最有可能受益於免疫療法的患者。

Shown on the right of the slide, NeoPredict significantly outperformed tumor mutational burden in Natera's perspective, bespoke IO clinical study. There has been increasing interest in these capabilities from KOLs, hospital systems and pharma companies, and we look forward to providing additional updates in the future.

如幻燈片右側所示，NeoPredict 在 Natera 定制的 IO 臨床研究中明顯優於腫瘤突變負擔。KOL、醫院系統和製藥公司對這些功能的興趣日益濃厚，我們期待在未來提供更多更新。

Now, let me hand it over to Mike to cover the financials. Mike?

現在，讓我把財務事宜交給麥克處理。麥克風？

Great. Thanks, Alex.

偉大的。謝謝，亞歷克斯。

The next page is just a summary of the financials compared to last year. We've already spent a lot of time on the revenue and OpEx trends so I won't repeat those.

下一頁只是與去年相比的財務狀況的摘要。我們已經在收入和營運支出趨勢上花費了大量時間，因此我不會重複這些。

A couple of the stats that sent out to me are:

發送給我的一些統計數據如下：

First, the top-line revenue growth over Q2 last year, where we had the big influx from the Invitae acquisition as Steve mentioned. I was pleased to see us grow very rapidly over and above that very tough comp from last year.

首先，與去年第二季相比，營收有所成長，正如史蒂夫所提到的，這得益於收購 Invitae 帶來的大量收入。我很高興看到我們比去年的競爭更加激烈，並且取得了快速成長。

Second, the major ramp we've seen in gross margin jumps out. That's driven by the ASP progress we've delivered over the last year. Steve talked about several near-term drivers to ASPs and I'm cautiously optimistic that we'll be able to make more progress in the second half, particularly related to Signatera ASPs.

其次，我們看到毛利率大幅上升。這是由我們在過去一年中取得的 ASP 進展所推動的。史蒂夫談到了 ASP 的幾個近期驅動因素，我謹慎樂觀地認為我們將能夠在下半年取得更多進展，特別是在 Signatera ASP 方面。

For example, we previously set a goal to get some ASP traction from biomarker states by Q3 2025. And I'm pleased to see some notable progress on specific payers in several states. So I feel confident that our Signatera accrual in Q3 will have some biomarker state benefit.

例如，我們先前設定了一個目標，到 2025 年第三季從生物標記狀態中獲得一些 ASP 牽引力。我很高興看到幾個州在特定付款人方面取得了顯著進展。因此，我相信我們在第三季的 Signatera 累積將會帶來一些生物標記狀態效益。

On the quarterly trajectory of gross margins, I'm very happy to see some COGS headwinds in Signatera when that is driven by an influx of first-time patients, which is what we saw in Q2, as Steve described. Finally, I was pleased to see us continue to generate cash even as we double down on the growth investments Steve described for this year. Obviously, that's driven by the revenues and the margins, but also the rapid improvements in the cash conversion dynamics that we talked about earlier in the call.

在季度毛利率走勢上，我很高興看到 Signatera 的一些 COGS 阻力，這是由首次患者的湧入所驅動的，正如史蒂夫所描述的，我們在第二季度看到了這種情況。最後，我很高興看到，即使我們加倍投入史蒂夫今年所描述的成長投資，我們仍能繼續產生現金。顯然，這是由收入和利潤推動的，也是由我們在電話會議早些時候談到的現金轉換動態的快速改善所推動的。

This is really part of the revenue cycle operations that improved ASP but also allow us to get reimbursed for covered services in a much more timely manner by optimizing the initial claim submission to payers with all the documentation they need to pay the claim on the first pass. As you can see from the bottom row, we've added approximately $47 million in cash from operations to the balance sheet this year and remain extremely well capitalized with a clean balance sheet.

這實際上是收入週期營運的一部分，它不僅提高了 ASP，還使我們能夠透過優化向付款人提交的初始索賠以及他們在第一次支付索賠所需的所有文件，以更及時的方式獲得承保服務的報銷。從底行可以看出，今年我們已向資產負債表添加了約 4700 萬美元的經營現金，並且透過清晰的資產負債表保持了極其充足的資本。

One other comment on the bottom line: we took an accrual of approximately $30 million in non-cash stock-based comp and legal expense accruals in the quarter, which I view as non-recurring. Without that charge, we estimate EPS loss per share would have been roughly $0.53 instead of the $0.74 we showed in the press release.

關於底線的另一條評論是：本季度我們提列了約 3000 萬美元的非現金股票補償和法律費用，我認為這是非經常性的。如果沒有這項費用，我們估計每股收益損失將約為 0.53 美元，而不是新聞稿中顯示的 0.74 美元。

Okay. Let's get to the guide update on the next slide. We are completely resetting the revenue guide to a new range, as Steve described, now ranging from $2,020 million to $2,100 million on the strength of the revenues and the volumes we've seen so far this year.

好的。讓我們看看下一張投影片上的指南更新。正如史蒂夫所描述的，我們正在將收入指南完全重置到一個新的範圍，根據今年迄今為止的收入和交易量，現在的範圍是從 20.2 億美元到 21 億美元。

The gross margin, we are bumping the bottom end of the range, 100 basis points to account for the good results we've generated so far this year. This guide implies that ASP trends will continue to improve while also building in expectations for continued increased adoption in first-time Signatera patients through the rest of the year.

我們將毛利率下限提高 100 個基點，以反映今年迄今為止我們所取得的良好表現。本指南暗示 ASP 趨勢將持續改善，同時也預期在今年剩餘時間內首次接受 Signatera 治療的患者採用率將持續提高。

So the net impact of those drivers should be that organic gross margin will continue to pick up modestly in the second half. For both revenues and gross margins, I will stress that we do not include revenue true-ups in the guide because they can be lumpy and challenging to forecast. I do expect some true-up revenue through the course of the year as the most recent reimbursement trends have been outpacing our historical results as you see in Q1 and Q2.

因此，這些驅動因素的淨影響應該是有機毛利率將在下半年繼續小幅回升。對於收入和毛利率，我要強調的是，我們沒有在指南中包括收入真實值，因為它們可能不穩定且難以預測。我確實預計今年會有一些實際收入，因為正如您在第一季和第二季看到的那樣，最近的報銷趨勢已經超過了我們的歷史業績。

On both the SG&A and R&D lines, we're holding that guide flat to the guidance we set in May. I'll just reiterate the point that Steve made on the slingshot effect with respect to these investments.

對於銷售、一般及行政開支和研發費用，我們都將該指引與 5 月設定的指引持平。我只想重申史蒂夫關於這些投資的彈弓效應的觀點。

Very little of the 2025 growth in OpEx is driving revenues this year but we do expect those to drive growth in 2026 and beyond. We are going to remain opportunistic as it relates to OpEx. If we see a chance to fund an important clinical trial or expand a territory beyond the current plan, we're going to do that because we are seeing such steady returns come in reliably on these investments.

2025 年營運支出的成長中，只有極小部分會推動今年的收入，但我們預期這些成長將推動 2026 年及以後的成長。在營運支出方面，我們將繼續保持機會主義。如果我們看到有機會資助一項重要的臨床試驗或擴大當前計劃之外的領域，我們就會這樣做，因為我們看到這些投資可靠地獲得了穩定的回報。

Finally, just reiterating our cash guide to be cash flow positive this year. The cash flows can be very lumpy, and it's certainly possible for variables like DSOs to bounce around, but our first half performance puts us in great position for the full year I'm biased toward the business generating cash again in the second half year in year 2025.

最後，重申我們的現金指南，今年的現金流將為正值。現金流可能會非常不穩定，而且 DSO 等變數也確實有可能出現波動，但我們上半年的業績使我們在全年處於有利地位，我傾向於認為該業務將在 2025 年下半年再次產生現金。

Okay. With that, let me open it up to questions. Operator?

好的。好了，現在讓我開始回答問題。操作員？

(Operator Instructions)

（操作員指示）

Daniel Brennan, TD Cowen.

丹尼爾布倫南 (Daniel Brennan)，TD Cowen。

Obviously, congrats on the quarter. Maybe just starting off with Signatera volumes, given the 20,000 sequential. It was a record. Maybe you can just give us some more color on what drove it.

顯然，對本季表示祝賀。考慮到連續 20,000 份的銷量，也許剛從 Signatera 的銷量開始。這是一個紀錄。也許您可以給我們更詳細地講講導致這種情況的原因。

Could you speak a little bit about maybe like existing docs and new docs? I think you talked about new patient starts versus maybe surveillance. I know, Steve, you also talked about new indications. So maybe you could just give us some more flavor what drove it?

您能否稍微談談現有文件和新文件？我認為您談論的是新患者的開始治療與可能的監視。我知道，史蒂夫，你也談到了新的跡象。那麼也許您可以給我們進一步解釋一下是什麼導致了這個現象？

The question would be, I know you want to keep this conservative, but is it unrealistic to think something in the high-teens to 20% could continue?

問題是，我知道你想保持保守，但認為百分之十幾到百分之二十的成長率能持續下去是否不切實際？

Yeah. Thanks, Dan. So I'd say, first, if you look at the broad amount of data that we've been putting out over the last year and particularly, the beginning part of this year, we had some really strong data at ASCO GI with the 702 study around the [socox-abuse]. I think that has filtered its way in and doctors are really starting to take hold of that.

是的。謝謝，丹。所以我想說，首先，如果你看一下我們去年發布的大量數據，特別是今年年初，我們在 ASCO GI 上獲得了一些非常有力的數據，其中有 702 項研究圍繞[socox-濫用]。我認為這種現像已經逐漸滲透進來，醫生們也開始真正掌握它了。

So we saw excellent growth in colorectal; excellent growth in breast cancer and immunotherapy monitoring. And then, as we said on the call, when doctors start using our product, they want to expand and start to use it for other tumors. So there's a little bit of everything when it comes to the histologies.

因此，我們看到大腸癌、乳癌和免疫療法監測領域的出色成長。然後，正如我們在電話中所說的那樣，當醫生開始使用我們的產品時，他們希望擴大其應用範圍並開始將其用於治療其他腫瘤。因此，當談到組織學時，一切都有一點。

We also saw an incredible record in new patients. And that's really -- I think one of the most important metrics to look at is are the doctors continuing to order not just on patients that they ordered a year ago but when a patient walks in the door, are they choosing our tool to make a decision? Or are they choosing a competitor tool or they're not using MRD at all.

我們也看到了新患者令人難以置信的記錄。而這確實是──我認為要關注的最重要的指標之一是醫生是否繼續為一年前開立的病人開處方，而且當病人走進門時，他們是否選擇我們的工具來做出決定？或者他們選擇了競爭對手的工具或他們根本沒有使用 MRD。

We saw just absolute blowout record twice higher growth than we've ever seen before in new patients. So we think that's a very good sign. And of course, it's a mix of new customers that are coming in for the first time and then, customers that have started using us and are now starting to, I think, broaden their use either to more patients or to more use cases.

我們看到新患者數量的成長絕對創下了歷史新高的兩倍。所以我們認為這是一個非常好的跡象。當然，其中既有首次加入的新客戶，也有已經開始使用我們產品的客戶，我認為，他們現在開始將產品用途擴大到更多患者或更多用例。

Terrific. And maybe just as a follow-up for Solomon or Steve or anyone on the team here. Just in terms of the clinical read-outs, you went through a lot of the studies that are ongoing in breast. You talked about the treatment on molecular response. Could you just give us a sense over the next, say, 12 or 18 months?

了不起。也許只是作為對所羅門或史蒂夫或這裡團隊中任何人的後續行動。僅就臨床讀數而言，您已經研究了大量正在進行的乳癌研究。您談到了分子反應治療。您能否告訴我們未來 12 或 18 個月的情況？

You mentioned IMvigor011, which I think could be guideline inclusive. So we have that one coming up. What are some of the other ones that you would point to across the next 18 months or two years? I'm sure they're all important but are there any more that are important than not that could actually be either guideline-inclusive or really drive some meaningful change in practice.

您提到了 IMvigor011，我認為它可以作為指導方針。所以我們將討論這個問題。您還想指出未來 18 個月或兩年內還有哪些趨勢？我確信它們都很重要，但是否還有更重要的、可以真正納入指導方針或真正推動實踐中一些有意義的變化的呢？

Yeah, Dan, that's a great question. I'll just make a couple of comments and then maybe Solomon or Alex, if you guys want to comment on. I think first IMvigor011. That's obviously a big one, FDA-enabling trial. We believe the results will be released in the future.

是的，丹，這是一個很好的問題。我只想發表幾點評論，然後也許還有所羅門或亞歷克斯，如果你們想評論的話。我首先想到的是IMvigor011。這顯然是一個大型的、經 FDA 批准的試驗。我們相信結果將會在未來公佈。

We're super excited about that. A very good indication, muscle-invasive bladder cancer. Hopefully, we'll have also some new data read-out at ESMO this year, which I think will be good.

我們對此感到非常興奮。一個很好的跡像是肌肉層浸潤性膀胱癌。希望我們今年也能在 ESMO 上讀出一些新的數據，我認為這會很好。

We talked about gastroesophageal and liver papers. Those have actually just been published, which is super exciting. That's one of the important steps to putting yourself in a position to get coverage -- is having a peer-reviewed publication.

我們討論了胃食道和肝臟論文。這些實際上剛剛出版，這非常令人興奮。這是讓自己獲得報導的重要步驟之一——擁有經過同儕審查的出版品。

Solomon, do you want to walk through a couple of the other; or maybe Alex, I know we talked a little bit about data, when the next read-out from that maybe. Anything else you want to highlight?

所羅門，你想介紹其他幾個嗎？或者也許是亞歷克斯，我知道我們談了一點數據，也許下一次讀出就是從那裡開始。還有什麼想強調的嗎？

I think the other one that we've talked about before are the NRG sponsored colorectal trial to Circulate US and there's a few other Circulate trials globally that are likely to have either an interim or a primary read-out over the next 18 to 24 months. That includes, hopefully, the de-escalation arm Vega from the Japan Circulate trial.

我認為我們之前討論過的另一個是 NRG 贊助的 Circulate US 結直腸試驗，全球還有其他一些 Circulate 試驗，這些試驗可能會在未來 18 到 24 個月內進行中期或初步讀數。希望其中包括來自日本 Circulate 試驗的降級武器 Vega。

So I would just highlight those two in CRC that could definitely make a difference for guidelines and beyond. We'll keep you everyone up to date.

因此，我只想強調 CRC 中的這兩個方面，它們肯定會對指導方針及其他方面產生影響。我們將及時向大家通報最新情況。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Steve and team, first one, Signatera, congrats on the quarter and the guide raise here Signatera volumes quarter to quarter really strong. Could you talk a little bit about was there any contribution from post-ASCO pickup? There was a newfound appreciation for MRD at ASCO. Obviously, that crowd has known MRD for years but it appeared it lifted more.

史蒂夫和團隊，首先是 Signatera，祝賀本季度，並且 Signatera 的季度銷售指南有所提升，非常強勁。您能否稍微談談 ASCO 之後的回升是否有任何貢獻？ASCO 對 MRD 有了新的體會。顯然，那群人已經認識 MRD 多年了，但看起來它的作用更大。

And then, I would love to get your view and maybe from Mike as well, in terms of how should we be thinking about and how should investors think about the penetration of Signatera today and the continued room for expansion? How do you calculate the penetration in various indications?

然後，我很想聽聽您以及 Mike 的看法，關於我們應該如何思考以及投資者應該如何看待 Signatera 目前的滲透率以及持續擴張的空間？如何計算不同適應症的滲透率？

Yeah. That's a good question. So yeah, obviously, ASCO this year had enormous amount of oral presentations, posters on Signatera. There was just a huge buzz at the conference around MRD.

是的。這是個好問題。是的，顯然，今年的 ASCO 有大量關於 Signatera 的口頭報告和海報。會議上，MRD 引起了極大的轟動。

Everywhere you want, talking about MRD. So a lot of excitement coming out of that.

無論身在何處，都在談論 MRD。因此，這引起了很多興奮。

I think we did see a lot of strong momentum in the last month of the quarter coming out of there after a lot of the presentations. So that's a great sign, I think, going forward.

我認為，在進行了大量演示之後，我們確實在本季度的最後一個月看到了強勁的發展勢頭。所以我認為這對未來發展來說是一個好兆頭。

I think that buzz is continuing. From a penetration standpoint, we think this is very underpenetrated. Low single-digit penetration when you look broadly. What we're really starting to see is that this opportunity is very, very broad. When you look at doctors, especially community practice, they start using for colorectal, then they start with gastroesophageal, then they may order for lung, maybe order from bladder. They really start to go and expand throughout the practice.

我認為這種熱議仍在繼續。從滲透率的角度來看，我們認為這滲透率很低。從廣義上看，滲透率很低，只有個位數。我們真正開始看到的是，這個機會非常非常廣闊。當你看醫生，特別是社區醫生時，他們開始使用大腸癌，然後他們開始使用胃食道癌，然後他們可能會開立肺癌，也許會開具膀胱癌。它們在整個實踐過程中真正開始前進並不斷擴展。

So as we move through those stages with the physicians, we're just realizing how underpenetrated the opportunity is but how we have a presence in all of these offices. So we now have this very broad footprint that has set up a significant amount of data.

因此，當我們與醫生一起經歷這些階段時，我們才意識到機會是多麼的未被充分挖掘，但我們在所有這些辦公室中都佔有一席之地。因此，我們現在擁有非常廣泛的覆蓋範圍，並累積了大量數據。

We've built all this infrastructure. We have a lot of coverage in place. We have all of these studies underway. We're in a great position to now increase volume over time, based on all the infrastructure that we've put in place.

我們已經建造了所有這些基礎設施。我們已經有很多報道。我們正在進行所有這些研究。基於我們已經建立的所有基礎設施，我們現在處於有利地位，可以隨著時間的推移增加產量。

Got it. And then, on the PROCEED and FIND trials, I just wanted to understand your strategy, the timing. This is clearly a hard problem to crack. We saw a trial failure. In short, it was it meet the primary endpoint but it was below the NCD. That company subsequently licensed the technology from another company.

知道了。然後，關於 PROCEED 和 FIND 試驗，我只是想了解您的策略和時機。這顯然是一個很難解決的問題。我們看到了一次試驗失敗。簡而言之，它達到了主要終點，但低於 NCD。該公司隨後從另一家公司獲得了該技術的許可。

But just could you talk about the technology and the performance, the sensitivity, the AAs? What are you shooting for? When do you think when can we see the data? When can we see an FDA approval, reimbursement and then, launch?

但是您能談談這項技術、性能、靈敏度和 AA 嗎？你在拍攝什麼？您認為什麼時候我們可以看到數據？我們什麼時候可以看到 FDA 批准、報銷並推出？

Obviously, this market is -- there's a product on the market and it looks like now there is a entrant that's getting more of a boost. So I just want to understand the timing and how you're thinking about this market.

顯然，這個市場——市場上有一種產品，現在看起來有一個進入者正在獲得更大的推動力。所以我只是想了解時機以及您對這個市場的看法。

Yeah. Let me make a couple of comments and then maybe hand it over to Solomon -- or excuse me, to Alex to talk further.

是的。請允許我發表幾點評論，然後也許將其交給所羅門——或者對不起，交給亞歷克斯進一步討論。

But I'll just say first, we have a long history of doing in-house R&D and developing products ourselves, entering into new markets successfully, and also competing very well in highly competitive markets. So we think we're in a good position long term to make this a very significant component of Natera's overall business.

但我首先要說的是，我們在內部研發和自行開發產品方面有著悠久的歷史，我們成功進入了新市場，並且在競爭激烈的市場中也表現出色。因此，我們認為，從長遠來看，我們處於有利地位，可以將此作為 Natera 整體業務的一個非常重要的組成部分。

From a timing standpoint, the first -- the next major read-out is going to be the PROCEED trial. And PROCEED, if you remember, was collected exactly how you would collect samples in the FDA protocol. So it's not some other type of protocol, it's effectively drawing the blood and then the patient goes and gets colonoscopy. So it's a screening protocol that exactly aligns to what you would see in an FDA trial.

從時間角度來看，第一個—下一個主要的讀數將是 PROCEED 試驗。如果你還記得的話，PROCEED 的收集方式與 FDA 協議中收集樣本的方式完全相同。所以它不是其他類型的協議，而是有效地抽血，然後讓患者去做大腸鏡檢查。因此，這是一個與 FDA 試驗中看到的完全一致的篩選協議。

When the results from that read-out, we've already enrolled 3,000 patients. We have all the samples. They're being run. It's going to be read out, I think, we said late fall. From there, you're going to get a very, very good sense of how the test performs, particularly in -- I think that the focus is going to be in advanced adenomas and also on the specificity.

當讀出結果時，我們已經招募了 3,000 名患者。我們有所有的樣品。他們正在奔跑。我認為它將會被讀出來，我們說的是深秋。從那裡，您將非常非常了解測試的表現，特別是 - 我認為重點將放在晚期腺瘤以及特異性上。

So I think that's going to put us in a great position to really have much more of an acute sense of what the performance is going to be in the FDA-enabling study. And I think that's a little bit different maybe than the approach that some others have taken historically.

所以我認為這將使我們處於一個非常有利的位置，能夠更敏銳地了解 FDA 支持研究中的表現。我認為這可能與其他一些人過去採取的方法略有不同。

And then, if you look back to the CRC data that we read out earlier this year, I think, shortly after J.P. Morgan or maybe right around that timeframe, if you remember, we had a lot of screening identified asymptomatic colorectal cancer patients in those cohorts.

然後，如果您回顧我們今年早些時候讀出的 CRC 數據，我想，在摩根大通之後不久，或者可能就在那個時間段，如果您還記得的話，我們在這些群體中進行了大量的篩檢，發現了無症狀的結直腸癌患者。

So again, a little bit different from the strategy some others have taken previously, where they don't really have the screening detected asymptomatic patients included the cohort. We think that that reduces the likelihood of drop off as you move forward.

因此，這與其他一些人之前採取的策略略有不同，他們實際上並沒有將篩檢發現的無症狀患者納入其中。我們認為，這會降低您前進過程中退出的可能性。

So look, stay tuned for the read-out. It's super exciting for FIND. That trial is already up and running. We've already enrolled patients. We think that can be complete enrollment potentially late 2016. And we can be in a position to read out the results and submit to the FDA in 2027.

所以，請繼續關注結果。這對於 FIND 來說非常令人興奮。該試驗已開始並正在進行。我們已經招募了患者。我們認為，2016 年底可能就能完成招生。我們可以在 2027 年讀出結果並提交給 FDA。

Alex, do you want to add anything?

亞歷克斯，你還有什麼要補充嗎？

Yeah. Great question. Yeah. The only thing I'll add is we're very aware, right, the degradation can occur. And we do believe that probably the biggest source of degradation is poorly matching the FDA study with the case-control studies that are being used to assess early assay performance.

是的。好問題。是的。我唯一要補充的是，我們非常清楚，情況可能會惡化。我們確實認為，最大的問題可能是 FDA 研究與用於評估早期檢測性能的病例對照研究的匹配度很差。

So we've really taken a very thoughtful strategy of really launching the PROCEED study and using that as the basis for the FIND study, right? So the study really rolled from proceed into FID. So the enrollment criteria, the processes for enrolling patients are very, very similar, found the same. This allows us to really accrue samples from PROCEED, which hopefully are matched almost one-to-one with the final FIND study.

所以我們確實採取了一個非常周到的策略，真正啟動了 PROCEED 研究，並以此作為 FIND 研究的基礎，對嗎？因此，這項研究實際上已從進行階段進入最終投資決定階段。因此，入組標準、入組患者的流程非常非常相似，發現相同。這使我們能夠真正從 PROCEED 中累積樣本，希望這些樣本與最終的 FIND 研究幾乎一一相匹配。

And then, the last thing I'll say is that while getting enough prospectively collected colon cancer may be difficult, actually collecting enough advanced adenomas to read out a very good performance estimate is much easier, right, because the rates of advanced adenoma are between 5% to 10%.

然後，我要說的最後一件事是，雖然前瞻性地收集足夠的結腸癌樣本可能很困難，但實際上收集足夠的晚期腺瘤樣本來讀出非常好的性能估計要容易得多，對吧，因為晚期腺瘤的發生率在 5% 到 10% 之間。

So from PROCEED, we're going to get hundreds of advanced adenoma samples. So this allows us to actually read out with a well-powered cohort and really estimate what the final performance of the assay is going to be.

因此，從 PROCEED 中，我們將獲得數百個晚期腺瘤樣本。因此，這使我們能夠透過強大的佇列實際讀取數據，並真正估計分析的最終效能。

So we're doing that. We're going to read out some data end of the year. There could be additional read-outs right before the final read-out for the FIND study.

所以我們這麼做了。我們將在年底讀出一些數據。在 FIND 研究的最終讀數之前可能會有額外的讀數。

And then, Steve mentioned, FIND is going -- it's enrolling. We're very, very excited. Right now, we're guiding to read-out of that study in 2027. But as we get closer to that date, we'll further refine our guidance.

然後，史蒂夫提到，FIND 正在進行中——它正在招生。我們非常非常興奮。目前，我們正在指導在 2027 年讀完這項研究。但隨著該日期的臨近，我們將進一步完善我們的指導。

Got it. Super. And then, just if I could squeeze one in, just given the number of inbounds that I'm getting very quickly. Briefly, if you could provide me a number of product launches this year, just if you could encapsulate that and how quickly can you monetize the AI initiatives that you talked about and turn them into assays and products and to start to see revenue there?

知道了。極好的。然後，如果我能擠進一個，考慮到我很快就收到的入站數量。簡而言之，如果您可以提供今年推出的產品數量，請概括一下，您能多快將您談到的人工智慧計劃貨幣化並將其轉化為分析和產品，並開始看到收入？

Yeah, I'll take -- I'll comment and then, Alex jump in again. But yeah, on product launches, we just announced Fetal Focus. We're excited about that. We launched Venom earlier in the year.

是的，我會接受 - 我會發表評論，然後亞歷克斯再次加入。但是的，在產品發布會上，我們剛剛宣布了 Fetal Focus。我們對此感到很興奮。我們在今年早些時候推出了 Venom。

As we said, we've got several other things coming, largely focused around MRD. So I think stay tuned as those launch. We'll give you guys an update but lots of cool stuff happening, lots of MRD-related activity that's on track coming down the pipe. So the vast vague or investment there is focused on MRD.

正如我們所說，我們還將推出其他幾項舉措，主要集中在 MRD 方面。因此我認為請繼續關注這些產品的發布。我們會向你們提供最新消息，但很多有趣的事情正在發生，許多與 MRD 相關的活動正在按計劃進行。因此，那裡的大量投資都集中在 MRD 上。

And then on the AI side, I think there's -- we talked about a couple of different things. One is efficiency improvements in UX tools. Those are going to be rolled out over a period of time. Some of that works just beginning. Some of that work has been underway. That's really more cost reduction and user experience.

然後在人工智慧方面，我認為——我們談論了一些不同的事情。一是UX工具的效率提升。這些措施將在一段時間內陸續推出。其中一些工作才剛開始。部分工作已在進行中。這確實可以降低成本並提升用戶體驗。

The more technical medically focused stuff is super exciting. And we think there, there's a couple of different opportunities to commercialize. One is you've seen some of these big multi-$100 million, multimillion dollar deals with pharma companies or partnerships.

更具技術性的醫學重點的東西非常令人興奮。我們認為，存在一些不同的商業化機會。一是你已經看到了一些與製藥公司或合作夥伴達成的數億美元、數百萬美元的大交易。

We think we have an incredibly unique dataset, an incredibly unique set of tools and foundation models that are going to be important, very important for pharma going forward. I think this, for the first time, puts us in a position to be doing those very large deals.

我們認為我們擁有一套非常獨特的資料集、一套非常獨特的工具和基礎模型，這些對於製藥業未來的發展非常重要。我認為這是我們第一次有能力進行如此大規模的交易。

And then, the second is we're going to be commercializing a lot of the stuff through our current diagnostic platforms, either as add-on capabilities alongside our existing tests or as standalone biomarkers.

第二，我們將透過目前的診斷平台將許多東西商業化，要麼作為我們現有測試的附加功能，要麼作為獨立的生物標記。

Catherine Schulte, Baird.

凱瑟琳舒爾特，貝爾德。

Maybe first, you talked about the $250 million to $300 million of revenue from potential Medicare coverage of non-covered indications. Can you just give us a bit more in terms of details on the timeline for some of these submissions? How should we think about those being paced going forward?

也許首先，您談到了醫療保險對未涵蓋的適應症的潛在覆蓋所帶來的 2.5 億至 3 億美元的收入。您能否向我們詳細介紹一下這些提交內容的時間表？我們該如何看待這些正在向前邁進的人？

Yeah. Good question. So yeah, for that, we basically just looked at all the non-covered indications and the volume that we have there that we're not billing and we said, what would it be worth if we got covered for that basically in the next 12 to 18 months or something in that time frame.

是的。好問題。是的，為此，我們基本上只是查看了所有未涵蓋的適應症和我們未計費的數量，然後我們說，如果我們在未來 12 到 18 個月或在此時間範圍內得到覆蓋，那將值多少錢。

You get $250 million, $300 million in revenue. So we're there's a lot of upside opportunity from the business that is already coming in just simply from getting these coverages.

你獲得了 2.5 億美元、3 億美元的收入。因此，我們只需獲得這些保險，就能從業務中獲得許多上升機會。

You can believe -- this is a big focus of ours is to get these commissions in and get coverage. So I think we said in the prepared remarks, at least 7% or something in that range. I was going to call today where we went over opportunities for 15 different submissions.

你可以相信——我們的一個主要關注點是獲得這些佣金並獲得報告。所以我認為我們在準備好的發言中說過，至少是 7% 或在這個範圍內。我今天要打電話，討論 15 種不同提交機會。

So I think there's going to be a lot coming. But you -- I think as you've seen it's not always as easy as just doing a submission. You have to have the right data and you have to make sure the trial is done the right way.

所以我認為接下來還會有很多事情發生。但是你——我想正如你所見，這並不總是像提交那樣簡單。您必須擁有正確的數據，並且必須確保試驗以正確的方式進行。

And so we've developed a significant expertise in doing the right MRD trials in submitting those and getting coverage. That's what we're doing, again, in all these other indications.

因此，我們在進行正確的 MRD 試驗、提交這些試驗並獲得覆蓋範圍方面積累了豐富的專業知識。這正是我們在所有其他跡像中所做的。

Okay. Great. And then, you highlighted, I think over $150 million in breast cancer clinical trials. Is that signaling real focus on breast in terms of prioritizing additional indications. You've got a competitor potentially coming as a large presence on risk of recurrent tier breast cancer. So just maybe talk through how you view your competitive position in that cancer type.

好的。偉大的。然後，您強調，我認為乳癌臨床試驗的費用超過 1.5 億美元。這是否表明我們在優先考慮其他適應症方面真正關注乳癌？您的競爭對手可能會在復發性乳癌風險方面佔據很大份額。那麼也許可以談談您如何看待自己在該癌症類型中的競爭地位。

Yeah. I think I think breast has always from the very beginning, been a major focus for us, along with initially colorectal immunotherapy monitoring and now really pan cancer. So if you look back at some of the trials we presented, I think the DARE study, which now has like 2,000-plus time points started in 2021 -- so four or five years ago now.

是的。我認為乳癌從一開始就一直是我們關注的重點，此外還有最初的結直腸免疫治療監測以及現在的全癌症。因此，如果回顧我們提出的一些試驗，我認為 DARE 研究現在已經有超過 2,000 個時間點，始於 2021 年——也就是四、五年前。

This isn't like a new thing. I think there's continued investments that are new, like, for example, the TEODOR study. But we've been investing heavily into breast the whole time. And like we said, we've invested and are in the process of investing over $150 million just in breast cancer alone in clinical trials. And that's in our budget, that's in the forecast that we've shown.

這並不是什麼新鮮事。我認為會有持續的新投資，例如 TEODOR 研究。但我們一直在乳房方面投入大量資金。正如我們所說的，我們僅在乳癌臨床試驗方面就已投資並正在投資超過 1.5 億美元。這在我們的預算中，也在我們的預測中。

So the point is that it's a big effort to do these things. And there's a lot of different trials that need to be done. And we're already doing it. We think it's going to be very hard for someone to come and replicate that.

所以重點是，做這些事情需要付出很大的努力。還有很多不同的試驗需要進行。我們已經在這麼做了。我們認為，對於其他人來說，複製這一點將會非常困難。

But obviously, breast is a big opportunity. There's a chance to really help a lot of patients. It's a cancer, I think that's very near to me and many others at the company as well for personal reasons.

但顯然，乳房是一個巨大的機會。這確實有機會幫助很多患者。這是一種癌症，我認為由於個人原因，它對我以及公司中的許多其他人來說都很有吸引力。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

First, on gross margin, in a period of strength -- how much was gross margin actually adversely affected by the launch of full exome? I'm just trying to get a baseline in advance of full exome gross margin improving over the next few quarters, especially given the first half strength. So that's the first one.

首先，就毛利率而言，在強勁時期，全外顯子組的推出實際上對毛利率產生了多大的不利影響？我只是想提前了解未來幾季全外顯子組毛利率的提高情況，尤其是考慮到上半年的強勁表現。這是第一個。

The second is on volume trajectory. You've been signaling that we should be modeling an expectation for 12,000 incremental clinical signatory units each quarter. The trailing four-quarter average is already about 16,000. At what point would you consider bumping that up?

第二個是關於成交量軌跡。您一直在暗示我們應該為每季增加 12,000 個臨床簽約單位建立預期模型。過去四個季度的平均值已經達到 16,000 左右。在什麼情況下您會考慮提高這項標準？

And the last one is on revenue strength and operating spend. In the first quarter, on a really strong top line, you increased operating spend. This quarter, again, really strong at the top line, but you maintained your operating spend guide.

最後一個是關於收入實力和營運支出。在第一季度，在營收表現強勁的基礎上，你們也增加了營運支出。本季度，營收再次表現強勁，但您維持了營運支出指南。

Is this a sign that you are where you want to be in terms of things like head count and number of R&D programs for the next several quarters??

這是否顯示你們在員工人數和研發項目數量等方面已經達到了你們想要的目標？

Yeah. I think, Mike, you can probably run the table there.

是的。我想，麥克，你大概可以管理好這個桌子。

Yeah. No, thanks for the question. Doug, remind me the first one again. I should have been writing those down. You gave me a good list.

是的。不，謝謝你的提問。道格，再提醒我第一個。我應該把這些寫下來。你給了我一份很好的清單。

I think --

我認為--

The gross margin.

毛利率。

Yeah. Yeah. The gross margins, I think, ex the big step-up we had in new patients, it's fair to estimate that the gross margin progression sequentially would have been similar to what we saw in Q1. So I think you would have had that same steady improvement in gross margins.

是的。是的。我認為，毛利率，除開新患者數量的大幅增加，可以合理地估計，毛利率的環比增長將與我們在第一季看到的類似。所以我認為你的毛利率也會同樣穩定地提高。

That really would have been driven by the bump up we had. Again, we had another bump up in Signatera ASPs primarily. We had another strong ASP quarter in Women's Health, which I was very pleased to see.

這確實可能是由我們的進步所推動的。再次，我們主要在 Signatera ASP 方面又有了一次提升。我很高興看到，我們在女性健康領域迎來了一個強勁的 ASP 季度。

I want to see those strong ASP traction we've had there. I want to see that maintain. We definitely saw that in the quarter.

我希望看到我們在那裡擁有的強大的 ASP 吸引力。我希望看到這一點得以維持。我們在本季確實看到了這一點。

Give me the next one again.

再給我下一個。

You beat by 16,000 on average the last four quarters. You even got up to 12. At what point are we moving that up?

過去四個季度，你們平均贏了 16,000 分。你甚至已經達到 12 了。我們什麼時候會將其提升？

Yeah. I think you have to move it up modestly. But I would just caution you not to anchor on any one quarter. The reason for that is just that there has to be some randomness there quarter to quarter, where well fluctuate up and down. So you should not allow for that.

是的。我認為你必須適度提高它。但我只是想提醒你不要停留在任何一個季度。原因在於每季都會存在一些隨機性，並且會出現上下波動。所以你不應該允許這樣的事情發生。

But beyond that, in terms of fundamental drivers, Steve covered them. We're really in a fantastic position here, where the operations are running incredibly smoothly. We're on the other side of a lot of very daunting challenges that we had to undertake to launch this category and things are rolling.

但除此之外，就基本驅動因素而言，史蒂夫已經涵蓋了它們。我們目前處於一個非常好的位置，各項營運都非常順利。為了推出這個類別，我們克服了許多非常艱鉅的挑戰，事情進展順利。

The data is coming in that we started years and years ago -- is reading out. So it's a great time, I think, for the whole space for (inaudible) patients.

我們多年前開始讀取的資料正在湧入。所以我認為，對於（聽不清楚）患者的整個空間來說，這是一個美好的時光。

I think I would just -- without laying out like a specific number, I'd say bumping up modestly versus our prior and just look out for fluctuations, that's to be expected. That's totally normal.

我認為我只是——沒有給出一個具體的數字，而是說與之前相比會適度上升，並且要注意波動，這是可以預料的。這完全正常。

Rachel Vatnsdal, J.P. Morgan.

摩根大通的 Rachel Vatnsdal。

I wanted to push a little bit further on the sales rep dynamics. You talked a bit about expanding your sales force. Can you walk us through how large is your sales force at this point? And where do you think that needs to be over the medium to long term?

我想進一步推動銷售代表的動態發展。您談到了擴大銷售團隊的問題。可以向我們介紹一下目前您的銷售團隊規模有多大嗎？您認為從中長期來看，這目標需要達成什麼程度？

And then, just specifically on some of the recent sales rep adds, how should we think about the productivity for those new reps as we get into later this year and into 2026 as well?

然後，具體到最近增加的一些銷售代表，我們應該如何考慮今年稍後以及 2026 年這些新銷售代表的生產力？

Yeah, it's a good question. So I think traditionally, we have like 150, 175 oncology reps, something in that range. I think we've executed a meaningful step-up. That was completed during Q2. So a lot of those folks are just coming out of training or just getting their feet wet out in the field, meeting customers and so forth.

是的，這是個好問題。所以我認為傳統上我們有 150 到 175 名腫瘤科代表，大概在這個範圍內。我認為我們已經實現了有意義的進步。該工作已於第二季完成。因此，許多人剛剛接受培訓或剛進入該領域，與客戶會面等等。

So in our view, normally, it six to nine months for the reps to really become productive. And that's just when you think about like all the complexity of the material, 100 peer-reviewed publications building relationships.

因此，我們認為，銷售代表通常需要六到九個月的時間才能真正發揮作用。當你考慮到所有材料的複雜性時，你會發現 100 篇經過同行評審的出版物正在建立關係。

So we're in this dynamic now, which I think we called like a slingshot effect on the call where we have this built-in expense line of the people that we've hired. But they're not really driving productivity yet at this point.

所以我們現在處於這種動態之中，我認為我們在通話中稱之為彈弓效應，我們有這條內置的、我們僱用的人員的費用線。但目前它們還沒有真正提高生產力。

As we look into -- when (inaudible) productive, what are some of the metrics that we look at? Obviously, we look at the number of new accounts that they're bringing on, account retention in the business, their ability to add on new doctors within the practice, their ability to expand from one tumor type to the other within the particular practice.

當我們研究－當（聽不清楚）有生產力時，我們會關注哪些指標？顯然，我們會關注他們帶來的新帳戶數量、業務中的帳戶保留率、他們在診所內增加新醫生的能力、以及他們在特定診所內從一種腫瘤類型擴展到另一種腫瘤類型的能力。

So I would just say those are the types of things that we look at. We don't really have like a -- just given the growth phase that we're in, we really -- we don't have like necessarily an immediate like revenue that every rep has to hit within x number of time. But there's certainly a lot of attention on the growth trajectory and the amount of return that's being driven by each drug.

所以我只想說這些就是我們所關注的事情。我們實際上並沒有——考慮到我們所處的成長階段，我們實際上——我們不一定有每個銷售代表必須在 x 個時間內達到的即時收入。但人們確實非常關注每種藥物的成長軌跡和帶來的回報金額。

Great. And then, for my follow-up, on Signatera, it sounds like you guys had another standout quarter there on new patient adds. Can you explicitly tell us how many new patients were added in the quarter for Signatera. And any color on what indication or use cases you primarily saw those in?

偉大的。然後，就我對 Signatera 的後續關注而言，聽起來你們在新增患者方面又度過了一個出色的季度。您能否明確告訴我們本季 Signatera 增加了多少新患者。您主要在哪些跡像或用例中看到這些顏色？

And then, as a follow-up to that, how should we think about this in terms of volume expectations for Signatera as we look into 2026?

然後，作為後續問題，展望 2026 年，我們該如何看待 Signatera 的銷售預期？

Mike, do you want to comment on new patients?

麥克，你想對新病人發表評論嗎？

Yeah, on new patients, just as I was just covering with Doug, if you had just a normal mix that we have, it would have been about 40 basis points. And so this is multiples of that, as Steve described in the call. I don't want to get into, like, laying that out as a KPI that within giving all the time because I know that the growth in new patient starts is a very volatile metric for the business.

是的，對於新患者，正如我剛才和 Doug 討論的那樣，如果您採用我們現有的正常組合，那麼費用大約為 40 個基點。正如史蒂夫在電話中所描述的那樣，這是數倍。我不想把它當作一個 KPI 來製定，因為我知道新病患數量的成長對於業務來說是一個非常不穩定的指標。

I think in terms of looking forward into 2026, it does give me some confidence now if you just look at that chart on the volume growth and the consistency of that. I'm actually surprised with like how consistent that has been.

我認為，展望 2026 年，如果你看一下銷量成長及其一致性的圖表，它確實給了我一些信心。我實際上對這種一致性感到驚訝。

That, plus just when you go to the academic conferences now, it used to be that MRD was like a new thing and it's to be examined and there's interesting data. Now, I just feel like the tone has shifted at those things where this is -- people doing MRD. This is going to be something that it looks like it's inevitably part of the standard of care in that.

除此之外，當你現在參加學術會議時，MRD 曾經是一個新事物，需要進行研究，並且有有趣的數據。現在，我只是覺得人們在做 MRD 這件事情上的基調已經改變了。這看起來不可避免地會成為護理標準的一部分。

That gives me a lot of confidence in the trajectory of the franchise, both rest of this year '26 and beyond.

這讓我對球隊的發展軌跡充滿信心，無論是今年剩餘還是以後。

Tycho Peterson, Jefferies.

傑富瑞 (Jefferies) 的 Tycho Peterson。

I didn't hear you mention Latitude, which I think was on deck for a mid-'25 launch tumor-naïve. You mentioned the question on how many products are you launching more coming in MRD. But delighted to get pushed out, what's the latest there? And then, have you ever sized the TOMR opportunity for Signatera? I think that's certainly very interesting.

我沒有聽到你提到 Latitude，我認為它將在 2025 年中期推出腫瘤免疫療法。您提到了關於您將在 MRD 中推出多少種產品的問題。但很高興被推出去，那裡有什麼最新消息？那麼，您是否曾為 Signatera 評估過 TOMR 機會？我認為這確實非常有趣。

Yes. Solomon, do you want to take this? Or Alex?

是的。所羅門，你想拿走這個嗎？還是亞歷克斯？

Sure. Yeah, thanks for those questions, Tycho. On the TOMR side -- or excuse me, on the Latitude side first, we're very excited about the progress there. So we presented excellent data recently, and we announced that sensitivity looking very good. I think at 81% specificity at 97% on a per-sample basis, we see that as competitive with any other tissue-free test on the market. We're already getting a lot of inbound requests and interest on it. So we're in the process of bringing that to our customers, and we'll talk more about that in a future update.

當然。是的，謝謝你提出這些問題，Tycho。在 TOMR 方面——或者對不起，首先是在 Latitude 方面，我們對那裡的進展感到非常興奮。因此，我們最近提供了出色的數據，並宣布敏感度看起來非常好。我認為，以每個樣本 97% 的特異性計算，其特異性達到 81%，與市場上任何其他無組織測試相比，它都具有競爭力。我們已經收到了很多對此的請求和興趣。因此，我們正在將其推廣給我們的客戶，我們將在未來的更新中詳細討論這一點。

On the TOMR side, we're really excited about TOMR. It's a concept we've been talking about with physicians and with investigators and with the investor community now for a while. I think the way we think about the size is really the surveillance setting for all the tumor types where Signatera can be used because that any of those patients who are being monitored for recurrence, if they ever turn positive, which some percentage, unfortunately will, those patients become eligible for some intervention.

在 TOMR 方面，我們對 TOMR 感到非常興奮。我們已經與醫生、研究人員和投資者群體討論過這個概念一段時間了。我認為，我們對規模的考慮實際上是對所有可以使用 Signatera 的腫瘤類型的監測設置，因為任何正在監測復發的患者，如果他們的檢測結果變為陽性（不幸的是，有一定比例的患者會出現陽性），那麼這些患者就有資格接受某種幹預。

Roughly between a quarter to a half of those patients will be negative -- excuse me, we'll be positive on a reflex scan and will be treated according to standard guidelines for treating metastatic disease.

其中大約四分之一到二分之一的患者結果為陰性——不好意思，反射掃描結果為陽性，將根據治療轉移性疾病的標準指南進行治療。

But the other half now up to three quarters, as we saw from the DARE study, will be negative on a scan. And that means that they're going to be looking for something else. Whether that's escalated imaging, which is the current standard, do a different type of scan, do it more frequently, or they become eligible for a novel clinical trial where they can get treated directly and look for that clearance of the ctDNA.

但正如我們從 DARE 研究中所看到的，另一半（現在多達四分之三）在掃描中結果為陰性。這意味著他們將要尋找其他東西。無論是升級成像（這是當前的標準），還是進行不同類型的掃描，更頻繁地進行掃描，或者他們是否有資格參加新的臨床試驗，在試驗中他們可以直接接受治療並尋求 ctDNA 的清除。

So I think there's going to be more and more trials coming out of this nature. But we see the overall opportunity as all recurrence monitoring.

所以我認為將會有越來越多的這類試驗。但我們認為整體機會在於所有復發監測。

Okay. That's helpful. And then, maybe shifting over to Organ. MolDX has proposed some changes to the transplant LCD for solid organ allograft rejection. I know this doesn't directly impact you, but, a, have you had communication with them? Are you confident it won't be an issue?

好的。這很有幫助。然後，也許會轉向 Organ。MolDX 針對實體器官移植排斥反應提出了一些針對移植 LCD 的改變。我知道這不會直接影響到您，但是，您與他們溝通過嗎？您有信心這不會成為問題嗎？

And then, one question we've gotten is, is there any risk that this could eventually spill over to MRD just in the whole concept of capitating the number of tests they're willing to cover?

然後，我們遇到的一個問題是，在他們願意承擔的測試數量的整個概念中，這最終是否有可能蔓延到 MRD 的風險？

Yeah. I'll take that. I think, first on LCD, we see it as upside for us. We're not in a position where we're running two different assays, like, running a DNA assay, running an RNA assay and billing for them separately. So our Organ Health test is DNA only. There's one bill. So we're not impacted by that at all.

是的。我會接受的。我認為，首先在 LCD 方面，我們認為它對我們是有利的。我們不會同時進行兩種不同的檢測，例如，進行 DNA 檢測、進行 RNA 檢測，然後分別計費。所以我們的器官健康測試只是 DNA。有一張賬單。所以我們完全沒有受到任何影響。

And then, the surveillance piece, we see as upside. Actually, when we look at the cadence, we see it as upside for us. So we're excited about that.

然後，我們認為監控部分有好處。實際上，當我們觀察節奏時，我們認為這對我們來說是有利的。所以我們對此感到很興奮。

Organ Health, like we said on the call, we talked mostly hear about Oncology. But we're doing really well. We're seeing a lot of big major academic centers switching over to us. That's across the board: kidney, heart and lung.

器官健康，就像我們在電話中說的那樣，我們主要談論的是腫瘤學。但我們做得確實很好。我們看到許多大型學術中心轉向我們。這是全面的：腎臟、心臟和肺。

We've got a ton of great data that's been published, very unique features that set us apart. So we're excited about continuing the opportunity to Organ Health.

我們已發布大量優秀數據，這些獨特功能使我們脫穎而出。因此，我們很高興能夠繼續為 Organ Health 提供這一機會。

And risk this concept of capitating number of tests by MolDX could spill into MRD?

而 MolDX 的這種測試次數上限概念可能會影響到 MRD 嗎？

I think that already exists in many ways, right, with these bundled reimbursement where it doesn't really matter how many tests they run. You're going to get paid a certain amount. That already exists in a significant portion of the business.

我認為這在很多方面已經存在了，對吧，透過這些捆綁報銷，他們進行多少次測試並不重要。您將獲得一定金額的報酬。這在相當一部分業務中已經存在。

And then, there's other tumor types where they have already said, hey, this is the cadence that we're going to reimburse for. So I don't think it's a risk. I think it already exists, where they look at what they think the appropriateness of ordering is.

然後，對於其他類型的腫瘤，他們已經說過，嘿，這是我們要報銷的節奏。所以我不認為這是一個風險。我認為它已經存在了，他們會考慮他們認為適當的排序方式。

In some cases, they put specific guidance in place. But normally, what we're seeing is the doctors order the test roughly around the cadence that MolDX is aligned with.

在某些情況下，他們會制定具體的指導。但通常情況下，我們看到的是醫生大致根據 MolDX 所對應的節奏安排測試。

So we don't see that as any real risk at all.

所以我們根本不認為這有什麼真正的風險。

That is all the time we have for questions. This will conclude today's conference call.

我們回答問題的時間就這麼多了。今天的電話會議到此結束。

Thank you for joining. You may now disconnect.

感謝您的加入。您現在可以斷開連線。