Guardant Health Inc (GH) 2025 Q3 法說會逐字稿

Good afternoon. Thank you for attending the Guardant Health Inc Q3 2025 earnings call. My name is Cameron, and I'll be your moderator for today. (Operator Instructions)

午安.感謝您參加 Guardant Health Inc 2025 年第三季財報電話會議。我叫卡梅倫，我將擔任今天的主持人。（操作說明）

And I would now like to pass the conference over to your host, Zarak Khurshid with Guardant Health. You may proceed.

現在，我謹將會議交給主持人，來自 Guardant Health 的 Zarak Khurshid。您可以繼續。

Thank you. Earlier today, Garden Health released financial results for the quarter ended September 30, 2025. Joining me today from Guardant are Helmi Eltoukhy, co-CEO; Amirali Talasaz, co-CEO; and Mike Bell, Chief Financial Officer.

謝謝。今天早些時候，Garden Health 發布了截至 2025 年 9 月 30 日的季度財務業績。今天與我一同出席的 Guardant 公司的有：聯合執行長 Helmi Eltoukhy、聯合執行長 Amirali Talasaz 和財務長 Mike Bell。

Before we begin, I'd like to remind you that during this call, management will make forward-looking statements within the meaning of federal. Securities laws. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. This call will also include a discussion of non-GAAP financial measures which are adjusted to exclude certain specified items, additional information regarding material risks and uncertainties, as well as the non-GAAP financial reconciliation. The most directly comparable GAAP financial measures are available in the press release Garden issued today, as well as in our 10K and other filings with the SEC. Gardens disclaims any intention or obligation to update or revise financial projections and forward-looking statements, whether because of new information, future events, or otherwise, except as required by law. The information in this conference call is accurate only as of the live broadcast. With that, I would like to turn the call over to Helmy.

在開始之前，我想提醒各位，在本次電話會議中，管理層將發表符合聯邦法律定義的前瞻性聲明。證券法。這些聲明涉及重大風險和不確定性，可能導致實際結果或事件與預期結果或事件有重大差異。本次電話會議還將討論非公認會計準則財務指標（已進行調整以排除某些特定項目）、有關重大風險和不確定性的補充資訊以及非公認會計準則財務指標的調節表。最直接可比較的 GAAP 財務指標可在 Garden 今天發布的新聞稿以及我們向美國證券交易委員會提交的 10-K 表格和其他文件中查閱。除法律要求外，花園公司聲明，無論由於新資訊、未來事件或其他原因，均無意願或義務更新或修改財務預測和前瞻性聲明。本次電話會議中的資訊僅在直播時有效。接下來，我想把電話交給赫爾米。

Thanks, Eric. Good afternoon and thank you for joining our third quarter 2025 earnings call. Starting on Slide three, Q3 was an exceptional quarter for Guardant Health, Inc. with broad-based growth across our business. Anthology volumes grew 40% as year-over-year volume growth continued to accelerate driven by Guardant360 Liquid, Guardant360 Tissue, and Reveal. Our biopharma business grew nicely year over year with positive CDx momentum and screening volume accelerated with a sequential increase of 8,000 SHIELD tests. Importantly, screening has started to generate meaningful revenue tracking at an annual run rate of approximately $100 million roughly one year into the commercial launch of the FDA-approved product.

謝謝你，埃里克。下午好，感謝各位參加我們2025年第三季財報電話會議。從第三張投影片開始，第三季度對於 Guardant Health, Inc. 來說是一個非凡的季度，我們的業務實現了全面成長。合集銷量成長了 40%，年銷售成長持續加速，這主要得益於 Guardant360 Liquid、Guardant360 Tissue 和 Reveal 的推動。我們的生物製藥業務年成長良好，CDx 勢頭良好，篩檢量也隨著 SHIELD 檢測量較上季增加 8,000 次而加速成長。重要的是，在獲得 FDA 批准的產品商業化推出大約一年後，篩檢業務已開始產生有意義的收入，年運行率約為 1 億美元。

Overall, we are very pleased with our performance this quarter delivering 39% year-over-year revenue growth and crossing over $1 billion in annualized revenue for the first time. Excluding screening, we reached a major milestone with the rest of the business becoming cash flow positive one quarter earlier than expected. Indeed, this quarter sets us up very well to deliver on the long-term plan that we laid out at our Investor Day last month. Lastly, we recently surpassed 1 million cumulative clinical patients tested by Guardant Health, Inc. and as such we want to highlight one of these patients with a story that captures the profound impact our tests are having in everyday clinical practice.

總體而言，我們對本季的業績非常滿意，實現了 39% 的同比增長，並且首次突破了 10 億美元的年化收入大關。除篩檢業務外，我們實現了重大里程碑，其餘業務的現金流量比預期提前一個季度轉正。事實上，本季的業績為我們實現上個月投資者日上製定的長期計劃奠定了非常良好的基礎。最後，我們最近累計接受 Guardant Health, Inc. 檢測的臨床患者人數突破了 100 萬，因此我們想重點介紹其中一位患者的故事，以展現我們的檢測在日常臨床實踐中產生的深遠影響。

A 67-year-old man had gone unscreened for colorectal cancer for several years despite his physician recommending colonoscopy or stool-based tests annually beginning in 2021. Each time the patient declined to be screened. In December 2024, the physician ordered a SHIELD blood test and the patient agreed to complete the blood draw during the same visit. The result came back positive. When his physician explained that a positive SHIELD result required a follow-up colonoscopy, the patient agreed to have the procedure despite previously resisting. The colonoscopy was performed in January 2025 revealing colorectal cancer. The patient quickly began treatment, and at his most recent follow-up, he had successfully completed therapy and was doing well.

一名 67 歲男子多年來一直沒有接受大腸癌篩檢，儘管他的醫生建議他從 2021 年開始每年進行大腸鏡檢查或糞便檢查。每次患者都拒絕接受篩檢。2024 年 12 月，醫生開立了 SHIELD 血液檢測單，患者同意在同一次就診時完成抽血。結果呈陽性。當醫生解釋 SHIELD 檢測結果呈陽性需要進行後續大腸鏡檢查時，儘管之前一直拒絕，患者還是同意接受檢查。2025年1月進行的大腸鏡檢查發現患有大腸直腸癌。患者很快就開始接受治療，在最近一次追蹤中，他已成功完成治療，恢復良好。

This is a powerful example of how the SHIELD blood test can remove barriers to screening, provide a more pleasant and convenient option for patients, and ultimately improve outcomes.

這是一個強而有力的例子，說明 SHIELD 血液檢測如何消除篩檢障礙，為患者提供更愉快、更方便的選擇，並最終改善治療效果。

Michael Bell: Now turning to top-line performance on Slide four. Q3 revenue grew 39% year over year to $265 million with strong performance again across our oncology screening and biopharma and data businesses. Taking a closer look at our oncology business on Slide five. Oncology revenue increased 31% to $184 million and oncology volumes increased 40% year over year to approximately 74,000 tests in the third quarter. Turning to Slide six. We have seen a clear acceleration in volume since July, following the introduction of Guardant360 Liquid on our smart platform.

麥可貝爾：現在來看第四張投影片，重點介紹主要表現。第三季營收年增 39% 至 2.65 億美元，腫瘤篩檢、生物製藥和數據業務再次表現強勁。第五張幻燈片將帶您更詳細地了解我們的腫瘤業務。第三季腫瘤科收入成長 31% 至 1.84 億美元，腫瘤科檢測量年增 40% 至約 74,000 次檢測。請看第六張投影片。自 7 月以來，隨著 Guardant360 Liquid 在我們的智慧平台上推出，銷量出現了明顯的加速成長。

Since then, we have launched two additional waves of applications, driving five consecutive quarters of accelerating volume growth and we look forward to future waves of smart app introductions to both through the power of Infinity AI to help fuel future growth. In addition to Guardant360 Liquid, Guardant360 Tissue and REVEAL volumes also experienced strong year-over-year growth. Moving on to Slide seven. As a reminder, our 1 million patient samples include more than 350,000 epigenetic profiles across more than 100 tumor types to bring powerful insights and new products to market faster than ever.

此後，我們又推出了兩波應用程序，推動了連續五個季度的銷量加速增長，我們期待未來借助 Infinity AI 的力量，推出更多智能應用程序，以推動未來的增長。除了 Guardant360 Liquid 之外，Guardant360 Tissue 和 REVEAL 的銷售也實現了強勁的同比增長。接下來是第七張投影片。再次提醒大家，我們的 100 萬個患者樣本包含 100 多種腫瘤類型的 35 萬多個表觀遺傳圖譜，能夠以前所未有的速度將強大的洞察力和新產品推向市場。

Infinity AI enables higher resolution mapping of tumor biology giving rise to not only entirely new products in the clinical business, but novel signatures for faster drug discovery relevant to our biopharma business and new commercial insights and decision support tools. Turning to Slide eight. To date, we have launched 15 groundbreaking smart apps on Guardant360 Liquid with dozens more in development that will roll out across Guardant360 Liquid, Tissue, and Reveal. Each new application builds towards what we see as a GPS for cancer care. Guiding physicians with the right insights at every step of the patient journey.

Infinity AI 能夠更高解析度地繪製腫瘤生物學圖譜，不僅在臨床業務中催生出全新的產品，而且還能為我們的生物製藥業務帶來新的特徵，從而加快藥物發現速度，並帶來新的商業見解和決策支援工具。翻到第八張幻燈片。到目前為止，我們已在 Guardant360 Liquid 上推出了 15 款突破性的智慧型應用程序，還有數十款正在開發中，這些應用程式將陸續在 Guardant360 Liquid、Tissue 和 Reveal 上推出。每個新應用都朝著我們所看到的癌症治療 GPS 的方向發展。在患者診療過程的每一步，為醫師提供正確的指導。

We believe these applications not only significantly expand the clinical utility of Guardant360 Liquid but further extend our technical leadership in the liquid CGP market. Looking more closely at some of the recent highlights within our oncology business on Slide nine. Guardant360 volume grew exceptionally with more than 30% year-over-year growth. Guardant360 Tissue also had a great quarter showing strong year-over-year acceleration following the major product upgrades released in the second quarter. Once again, Reveal contributed very nicely and continues to be our fastest-growing oncology product. In addition to the strong performance, we recently reached a major milestone with the submission of our PMA application to the FDA for Guardant360 Liquid.

我們相信這些應用不僅顯著擴展了 Guardant360 Liquid 的臨床用途，而且進一步鞏固了我們在液體 CGP 市場的技術領先地位。第九張幻燈片將更詳細地介紹我們腫瘤業務近期的一些亮點。Guardant360 的交易量實現了異常增長，同比增長超過 30%。Guardant360 Tissue 在第二季推出重大產品升級後，本季也表現出色，實現了強勁的年成長。Reveal再次表現出色，並持續成為我們成長最快的腫瘤產品。除了強勁的業績之外，我們最近還取得了重大里程碑式的進展，向美國食品藥物管理局 (FDA) 提交了 Guardant360 Liquid 的 PMA 申請。

This submission has the potential to streamline Guardant360 Liquid with a single flagship FDA-approved liquid biopsy for therapy selection, simplifying our portfolio, accelerating adoption, and further strengthening our leadership in this space. In addition, FDA approval would lay the foundation for ADLP designation which is an important mechanism for capturing the appropriate value for our expanded test offering in the future. We had a strong presence at ESMO 2025, with 15 abstracts spanning the cancer care continuum, from MRD detection and recurrence monitoring with studies such as PEGASUS to advanced stage tumor profiling and therapy response assessment. For REVEAL, we are making great progress with data generation and publications.

此次提交預計將簡化 Guardant360 Liquid，使其成為 FDA 批准的單一旗艦級液體活檢療法選擇方案，從而簡化我們的產品組合，加速產品推廣，並進一步鞏固我們在該領域的領先地位。此外，獲得 FDA 批准將為 ADLP 認定奠定基礎，這是未來為我們擴大的檢測服務獲取適當價值的重要機制。我們在 2025 年 ESMO 大會上表現出色，發表了 15 篇摘要，涵蓋了癌症治療的各個方面，從 MRD 檢測和復發監測（如 PEGASUS 研究）到晚期腫瘤分析和治療反應評估。對於 REVEAL 項目，我們在數據生成和發布方面取得了巨大進展。

We recently submitted our immuno-oncology therapy monitoring data package to MolDx to support Medicare reimbursement and submitted data from our chemotherapy monitoring study for publication. Turning to Slide 10 to take a closer look at our REVEAL data pipeline. Over the last few months, we have made significant progress in MRD, generating and publishing compelling data across multiple cancer types. Earlier this year, we achieved Medicare coverage for CRC surveillance and have since submitted dossiers for breast surveillance as I just mentioned for immuno-oncology therapy monitoring. We plan to submit packages for chemotherapy and CDK4/6 inhibitor monitoring following those publications. Looking ahead, we have ongoing studies across more than five additional tumor types in both the adjuvant and surveillance settings.

我們最近向 MolDx 提交了我們的免疫腫瘤治療監測資料包，以支持 Medicare 報銷，並提交了我們的化療監測研究數據以供發表。接下來請翻到第 10 張投影片，仔細看看我們的 REVEAL 資料管道。在過去的幾個月裡，我們在 MRD 方面取得了重大進展，產生並發布了多種癌症類型的有力數據。今年早些時候，我們獲得了 Medicare 對 CRC 監測的覆蓋，此後我們提交了乳癌監測的檔案，就像我剛才提到的免疫腫瘤治療監測一樣。我們計劃根據這些出版物提交化療和 CDK4/6 抑制劑監測的資料包。展望未來，我們正在針對五種以上的其他腫瘤類型進行輔助治療和監測的研究。

Together, this growing body of evidence will continue to strengthen the clinical utility and analytical validity of Reveal, supporting broader adoption in MRD. Turning now to Slide 11. I am proud of the progress we have made over the last few years in both driving demand and revenue growth across our portfolio. Looking ahead, we see multiple drivers across our oncology business that position us well for durable long-term growth. We will continue investing in commercial initiatives that make it easier for physicians to access our tests through portal enhancements, EMR integrations, and enhanced workflows.

越來越多的證據將共同加強 Reveal 的臨床實用性和分析有效性，從而支持其在 MRD 中得到更廣泛的應用。現在請看第11張投影片。我為我們過去幾年在推動產品組合的需求和收入成長方面取得的進展感到自豪。展望未來，我們看到腫瘤業務的多個驅動因素將使我們處於有利地位，並實現持久的長期成長。我們將繼續投資於商業舉措，透過入口網站改進、EMR 整合和改進工作流程，使醫生更容易獲得我們的檢測服務。

In our therapy selection business, transitioning to the smart platform unlocks wave after wave of novel applications, many unique to Guardant Health, Inc. that will help us differentiate and continue gaining market share. And in MRD, redoubled commercial focus on REVEAL supported by significantly lower COGS and Medicare coverage for CRC surveillance positions us for strong growth ahead. We are also excited to introduce an ultra-sensitive tissue-informed MRD assay that will complement our best-in-class tissue-free REVEAL test. Looking more closely at some of the recent highlights within our biopharma and data business in Slide 12. We delivered another strong quarter with third-quarter revenue growing 18% year over year.

在我們的治療選擇業務中，向智慧平台的過渡將解鎖一波又一波的新應用，其中許多應用是 Guardant Health, Inc. 獨有的，這將幫助我們脫穎而出並繼續獲得市場份額。在 MRD 領域，我們加倍專注於 REVEAL 的商業發展，同時大幅降低 COGS 並擴大 CRC 監測的 Medicare 覆蓋範圍，這為我們未來的強勁成長奠定了基礎。我們也很高興推出一種超靈敏的組織資訊 MRD 檢測方法，它將與我們一流的無組織 REVEAL 檢測方法相輔相成。在第 12 張幻燈片中，我們將更仔細地了解我們生物製藥和數據業務最近的一些亮點。第三季業績表現強勁，營收年增 18%。

We continue to deepen our relationships with large pharma and had two additional companion diagnostic approvals in Q3. In late September, Guardant360 CDx received FDA approval as a companion diagnostic to Inlureo for the treatment of ESR1 mutated advanced breast cancer. This marks the second FDA-approved indication in breast and the sixth overall CDx claim approved by the FDA for Guardant360 CDx. We also received regulatory approval in Japan for Guardant360 CDx as a companion diagnostic to Enhertu for non-small cell lung cancer patients with HER2 mutations. We now have 23 total CDx approvals across biomarker and tumor types. Our robust and growing pipeline of partnerships ensures that near-term revenue visibility remains high.

我們繼續深化與大型製藥公司的合作關係，並在第三季度獲得了兩項伴隨診斷產品的批准。9 月下旬，Guardant360 CDx 獲得 FDA 批准，作為 Inlureo 的伴隨診斷試劑，用於治療 ESR1 突變的晚期乳癌。這是 Guardant360 CDx 獲得 FDA 批准的第二個乳癌適應症，也是 FDA 批准的第六個 CDx 適應症。我們也獲得了日本監管部門的批准，Guardant360 CDx 可作為 Enhertu 的伴隨診斷試劑，用於治療 HER2 突變的非小細胞肺癌患者。目前，我們在生物標記和腫瘤類型方面共獲得了 23 項 CDx 批准。我們強大且不斷增長的合作夥伴關係確保了近期收入的可觀性。

With that, I will now turn the call over to AmirAli for an update on screening.

接下來，我會把電話轉給 AmirAli，請他回報篩檢的最新情況。

Thanks, Helmy. Moving on to Slide 13. We delivered $24 million of Shield testing revenue in Q3, driven by approximately 24,000 tests. It has been incredibly rewarding to see Shield volume take off and hear story after story of patients positively impacted by this pioneering test, such as the story Helmy highlighted at the beginning of our call. Now turning to Slide 14 to take a closer look at screening highlights for 2025. Starting with CRC screening, given the strong performance and growing demand, we have accelerated the building out of our commercial infrastructure beyond our original plan.

謝謝你，赫爾米。接下來是第13張投影片。第三季度，我們透過大約 24,000 次測試實現了 2,400 萬美元的 Shield 測試收入。看到 Shield 的銷售飆升，並聽到一個又一個患者因這項開創性檢測而受益的故事，真是令人無比欣慰，例如 Helmy 在我們電話會議開始時重點提到的那個故事。現在請翻到第 14 張投影片，仔細看看 2025 年的放映亮點。從 CRC 篩檢開始，鑑於其強勁的表現和不斷增長的需求，我們加快了商業基礎設施的建設，超越了我們最初的計劃。

In addition, the breakthrough nature of the Shield brand has provided us with strategic partnership opportunities, including our recently announced collaborations with Quest Diagnostics and PATH Group. Shield continues to generate strong demand from both patients and physicians with high adherence rates. As exemplified by the patient story we shared earlier, we are seeing Shield tests get completed with blood samples received for more than 90% of ordered cases. This demonstrates the simplicity of Shield as a routine blood test for CRC screening that can be implemented into routine PCP practice. We are encouraged by the performance of our Shield CRC V2, which demonstrated solid clinical performance with improved sensitivity for stage one colorectal cancer. Turning to our multi-cancer initiatives.

此外，Shield 品牌的突破性特性為我們提供了策略合作機會，包括我們最近宣布與 Quest Diagnostics 和 PATH Group 的合作。Shield 持續受到病患和醫師的強烈歡迎，且遵從率很高。正如我們先前分享的患者案例所示，在 90% 以上的已訂購病例中，透過血液樣本即可完成 Shield 檢測。這證明了 Shield 作為 CRC 篩檢常規血液檢測的簡單性，可以應用於 PCP 的常規實踐中。我們對 Shield CRC V2 的表現感到鼓舞，它展現了可靠的臨床性能，提高了對 I 期結直腸癌的敏感性。接下來談談我們的多癌種防治計劃。

We are very excited to announce that Shield Multi-Cancer is now available nationwide through our clinical data collection initiative. At our Investor Day last month, we shared strong real-world performance data for Shield MCD from a study of 9,251 individuals. Specificity was 99% consistent with earlier NCI findings and positive predictive value was 41%, meaning that when Shield is positive, there is a 41% likelihood of cancer being present. Lastly, we are proud to partner with the American Cancer Society and look forward to everyone having access to convenient and timely cancer screening so we can detect cancer earlier and provide opportunities for better outcomes.

我們非常興奮地宣布，Shield Multi-Cancer 現在已透過我們的臨床數據收集計劃在全國推出。在上個月的投資者日上，我們分享了 Shield MCD 在一項針對 9,251 名個體的研究中取得的強勁的實際業績數據。特異性為 99%，與 NCI 早期的研究結果一致，陽性預測值為 41%，這表示當 Shield 檢測結果為陽性時，有 41% 的可能性有癌症。最後，我們很榮幸能與美國癌症協會合作，並期待每個人都能獲得便利及時的癌症篩檢，以便我們能夠更早發現癌症，並為患者提供更好的治療效果。

Taking a closer look at our recent strategic partnerships to scale our commercial infrastructure on Slide 15. First, we were very excited to announce a strategic collaboration with Quest to expand and accelerate Shield Access more broadly in the US Quest's provider clients will be able to order Shield Tests and receive the results directly through the Quest connectivity system. We believe this strategic collaboration is valuable in two ways. First, it enables a better ordering experience and brings forward our nationwide EMR strategy by several years. This will give us immediate connectivity to 650,000 clinician and hospital accounts in the Quest system. We believe this accelerated connectivity will drive our scale.

在第 15 張投影片中，我們將更詳細地了解我們最近為擴大商業基礎設施規模而建立的策略合作夥伴關係。首先，我們非常興奮地宣布與 Quest 達成戰略合作，以在美國更廣泛地擴展和加速 Shield Access 的普及。 Quest 的供應商客戶將能夠訂購 Shield 測試，並透過 Quest 連接系統直接接收結果。我們認為這種戰略合作在兩方面都很有價值。首先，它帶來了更好的訂購體驗，並將我們的全國電子病歷策略提前了數年。這將使我們能夠立即連接到 Quest 系統中的 65 萬個臨床醫生和醫院帳戶。我們相信，這種加速的互聯互通將推動我們的規模擴張。

We will also have access to deep logistical infrastructure, including 2,000 patient service centers, and 6,000 in-office phlebotomists in the United States. Second, Quest's promotional activities using their nationwide field force in combination with our own multi-100 person sales force will further strengthen our competitive position in the primary care market. Quest's national commercial sales team will proactively educate primary care physicians and OBGYNs about the SHIELD test, accelerating awareness and adoption among their ordering providers. We expect Shield to be available for physician order through Quest in 2026. We will continue to process all Shield tests and control client services and billing and reimbursement operations.

我們還將擁有完善的物流基礎設施，包括美國境內的 2,000 個病患服務中心和 6,000 名診所抽血員。其次，Quest 利用其遍布全國的銷售隊伍所進行的促銷活動，結合我們自己數百人的銷售隊伍，將進一步加強我們在初級保健市場的競爭地位。Quest 的全國商業銷售團隊將積極主動地向初級保健醫生和婦產科醫生普及 SHIELD 檢測，從而加快其訂購醫生對該檢測的認識和採用。我們預計 Shield 將於 2026 年透過 Quest 向醫生開放訂購。我們將繼續處理所有 Shield 測試，並控制客戶服務、計費和報銷作業。

In addition, we recently announced our partnership with PATH Group, which expands Shield's reach to more than 250 health systems across 25 states representing another exciting accelerator for physician and patient access. We are looking forward to seeing the positive impact of our growing commercial infrastructure in 2026 and years to come. We also remain confident in the potential inclusion of Shield in the American Cancer Society guidelines in the near future which should be a catalyst for broader patient access. Moving on to Slide 16. Our goal has always been to detect many cancer types early when they are most treatable. With that in mind, we developed Shield as a multi-cancer detection platform. Turning to Slide 17.

此外，我們最近宣布與 PATH 集團建立合作夥伴關係，這將使 Shield 的服務範圍擴大到 25 個州的 250 多個醫療系統，這代表著醫生和患者獲得醫療服務的另一個令人興奮的加速器。我們期待在 2026 年及以後的幾年裡，看到我們不斷發展的商業基礎設施帶來的正面影響。我們也仍然相信，Shield療法在不久的將來有可能被納入美國癌症協會的指南中，這應該會促進更廣泛的患者獲得治療。接下來是第16張投影片。我們的目標始終是儘早發現多種癌症類型，以便在最容易治療的時候進行治療。基於此，我們開發了 Shield，一個多癌症檢測平台。翻到第17張幻燈片。

And as I mentioned earlier, we have now broadened access to Shield multi-cancer detection. In order for a patient to access this result report, their physician will need to opt in to receive the multi-cancer report, and the patient will need to authorize the release of medical records to Guardant Health, Inc. We successfully piloted this workflow in several accounts and following overwhelming positive feedback from physicians and strong participation by patients, we expanded this offering nationwide. Moving on to Slide 18.

正如我之前提到的，我們現在已經擴大了 Shield 多癌種檢測的覆蓋範圍。病人若要取得此結果報告，其醫師需選擇接收多癌種檢測報告，且患者需授權向 Guardant Health, Inc. 揭露醫療記錄。我們已在多個帳戶中成功試點此工作流程，並獲得了醫生的壓倒性積極反饋和患者的積極參與，因此我們將此服務推廣至全國。接下來是第18張投影片。

The launch of this initiative establishes a scalable platform for clinical data generation, enables assessment of the utilization of MCD results in patient care, and provides a new avenue to expand patient access to multi-cancer detection, bringing this important innovation to a broader population. This nationwide initiative is expected to reach hundreds of thousands of participants making it one of the largest prospective evidence generation initiatives for early cancer detection. Turning now to Slide 19. With the expansion of Shield to include MCD results together with authorization to release medical data, we are now well-positioned to further strengthen our data moat.

這項計劃的啟動建立了一個可擴展的臨床數據生成平台，能夠評估 MCD 結果在患者護理中的應用，並為擴大患者獲得多癌症檢測的機會提供了一條新途徑，將這項重要的創新帶給更廣泛的人群。這項全國性計畫預計將惠及數十萬名參與者，使其成為癌症早期檢測領域規模最大的前瞻性證據生成計畫之一。現在請看第19張投影片。隨著 Shield 擴展至包含 MCD 結果以及發布醫療數據的授權，我們現在處於有利地位，可以進一步加強我們的數據護城河。

This high-quality data serves as a regulatory-grade source of truth, providing details on each patient's cancer journey that were previously not accessible. We will generate large-scale prospective evidence about the performance, clinical value, and safety profile. We believe this high-resolution data will power continuous improvement of Shield MCD, and also lay the foundation to potentially expand into multi-disease detection. With that, I will now turn the call over to Mike for more detail on our financials.

這些高品質數據可作為監管級別的真實來源，提供以前無法獲得的每位患者的癌症治療歷程的詳細資訊。我們將產生關於其性能、臨床價值和安全性的大規模前瞻性證據。我們相信，這些高解析度數據將推動 Shield MCD 的持續改進，並為未來擴展到多疾病檢測奠定基礎。接下來，我將把電話交給麥克，讓他詳細介紹我們的財務狀況。

Thanks, AmirAli. Turning to Slide 20. I will now review select financial highlights for the quarter ended September 30, 2025. Unless otherwise noted, all growth rates are year over year. Total revenue for the third quarter grew 39% to $265.2 million driven by strong performance across all three major revenue lines: Oncology, biopharma and data, and screening. Oncology revenue increased 31% to $184.4 million primarily driven by another quarter of accelerated test volume growth. We reported approximately 74,000 oncology tests in the third quarter, representing 40% growth reflecting continued positive momentum across the portfolio.

謝謝，AmirAli。翻到第20張投影片。接下來，我將回顧截至 2025 年 9 月 30 日的季度的部分財務亮點。除非另有說明，所有成長率均為年增速。第三季總營收成長 39% 至 2.652 億美元，主要得益於三大主要收入來源（腫瘤、生物製藥和數據以及篩檢）的強勁表現。腫瘤業務收入成長 31% 至 1.844 億美元，主要得益於檢測量連續第二季加速成長。第三季我們報告了約 74,000 例腫瘤檢測，年增 40%，反映了整個產品組合持續的正面動能。

Guardant360 Liquid delivered its fifth consecutive quarter of accelerating growth, with volumes up more than 30%, supported by the expanding clinical utility enabled by smart launched over the past year. Guardant360 Tissue also had an exceptional quarter, showing strong year-over-year acceleration following the major product upgrade released in the second quarter. Reveal remains our fastest-growing oncology product, benefiting from CRC surveillance reimbursement achieved earlier this year and continued strength across both breast and lung cancer indications. As a reminder, we do not include Guardant hereditary cancer testing or IHC volumes in our reported totals. We continue to expect minimal revenue contribution from these new offerings through 2025. Average selling prices remained stable compared to the prior quarter.

Guardant360 Liquid 連續第五個季度實現加速成長，銷量成長超過 30%，這得益於過去一年推出的 smart 功能所帶來的不斷擴大的臨床應用。Guardant360 Tissue 也取得了非凡的季度業績，在第二季推出重大產品升級後，實現了強勁的同比增長。Reveal 仍然是我們成長最快的腫瘤產品，受益於今年稍早 CRC 監測報銷的實現，以及在乳癌和肺癌適應症方面持續強勁的成長。再次提醒，我們報告的總數不包括 Guardant 遺傳性癌症檢測或 IHC 檢測量。我們預計到 2025 年，這些新產品帶來的營收貢獻將微乎其微。與上一季相比，平均售價保持穩定。

Guardant360 Liquid was in the range of $3,000 to $3,100, Guardant360 Tissue was approximately $2,000, and Reveal was in the range of $600 to $700. We also recognized approximately $5 million of out-of-period oncology revenue in the third quarter compared to $12 million in the prior year period. Our biopharma and data business continued to perform well, with revenue increasing 18% to $54.7 million, including milestone revenue from two companion diagnostic approvals achieved during the quarter. The biopharma pipeline remains solid, providing confidence in both the near-term and long-term growth prospects. Screening revenue from Shield totaled $24.1 million generated from 24,000 tests reported during the quarter. Shield ASP was approximately $880 above expectations, reflecting our continued focus on Medicare-covered patients.

Guardant360 Liquid 的價格在 3,000 美元到 3,100 美元之間，Guardant360 Tissue 的價格約為 2,000 美元，而 Reveal 的價格在 600 美元到 700 美元之間。第三季度，我們也確認了約 500 萬美元的非當期腫瘤業務收入，而去年同期為 1,200 萬美元。我們的生物製藥和數據業務持續表現良好，營收成長 18% 至 5,470 萬美元，其中包括本季獲得兩項伴隨診斷批准的里程碑收入。生物製藥產品線依然穩健，為近期和長期成長前景提供了信心。本季度，Shield 的篩檢收入總計 2,410 萬美元，來自 24,000 次檢測。Shield ASP 比預期高出約 880 美元，這反映了我們持續關注 Medicare 覆蓋的患者。

We also recognized approximately $3 million of out-of-period screening revenue, driven by better-than-expected reimbursement from Medicare Advantage payers for tests performed in 2025. This positive trend reinforces our confidence in both near-term and long-term expectations for Medicare Advantage reimbursement rates and overall Shield ASP targets. Turning to Slide 21. We are very pleased with the year-over-year improvement in non-GAAP gross margin, which increased to 66% in Q3 2025 compared to 63% in the prior year period. This improvement was primarily driven by a significant reduction in REVEAL COGS, which have declined from over $1,000 per test in Q3 2024 to less than $500 per test, as well as strong progress in Shield gross margin.

我們也確認了約 300 萬美元的非週期性篩檢收入，這主要得益於 Medicare Advantage 付款方對 2025 年進行的檢測的報銷金額高於預期。這一正向趨勢增強了我們對 Medicare Advantage 報銷率和 Shield 整體 ASP 目標的近期和長期預期的信心。翻到第21張幻燈片。我們對非GAAP毛利率的年比改善感到非常滿意，2025年第三季毛利率增加至66%，而去年同期為63%。這項改善主要得益於 REVEAL 成本的大幅降低，從 2024 年第三季的每次測試超過 1000 美元降至每次測試不到 500 美元，以及 Shield 毛利率的強勁增長。

Shield's non-GAAP gross margin improved from negative levels at the launch just over a year ago to 55% in 2025. This improvement reflects strong ASPs under the Medicare ADLT rate of $1,495, disciplined focus on reimbursable tests, and continued COGS reduction. Shield's non-GAAP cost per test again trended lower sequentially and continues to be below $500 per test, consistent with our operational plan. These gains reflect the ongoing benefits of increased Shield volume and disciplined cost management. Turning to Slide 22. Non-GAAP operating expenses were $228.8 million in the third quarter, an increase of 22% in line with expectations. The increase was primarily driven by continued investments to expand our screening commercial infrastructure and scale sales and marketing for Shield.

Shield 的非 GAAP 毛利率從一年多前推出時的負值水準提高到 2025 年的 55%。這項改善反映了在 Medicare ADLT 費率 1495 美元下強勁的平均銷售價格、對可報銷測試的嚴格關注以及持續的銷售成本降低。Shield 的非 GAAP 每次偵測成本再次較上季下降，並持續低於每次偵測 500 美元，這與我們的營運計畫一致。這些收益反映了Shield銷售增加和嚴格的成本管理所帶來的持續效益。翻到第22張投影片。第三季非GAAP營運支出為2.288億美元，成長22%，符合預期。成長的主要原因是持續投資擴大我們的篩選商業基礎設施，並擴大 Shield 的銷售和市場規模。

As we conclude 2025 and enter 2026, we will maintain focus on these investments to maximize our first-mover advantage in blood-based colorectal cancer screening. Adjusted EBITDA loss was $45.5 million, an improvement of $10.7 million compared to a loss of $56.2 million in 2024. We remain disciplined in our approach to cash management. Free cash flow burn was $45.8 million, improving by $9.5 million compared to the prior year period. Importantly, excluding the screening business, Guardant Health, Inc. generated positive free cash flow during the quarter, a significant milestone achieved one quarter ahead of our stated target.

2025 年即將結束，2026 年即將到來，我們將繼續專注於這些投資，以最大限度地發揮我們在血液結直腸癌篩檢領域的先發優勢。調整後的 EBITDA 虧損為 4,550 萬美元，比 2024 年的虧損 5,620 萬美元減少了 1,070 萬美元。我們在現金管理方面始終保持嚴謹的態度。自由現金流消耗為 4,580 萬美元，比去年同期減少了 950 萬美元。值得注意的是，除篩檢業務外，Guardant Health, Inc. 在本季度實現了正自由現金流，這是一個重要的里程碑，比我們既定目標提前了一個季度實現。

We expect the core business to remain free cash flow positive in the fourth quarter as well as for the full year 2026 and beyond. We ended the quarter with approximately $690 million in cash, cash equivalents, and restricted cash. Turning to the full-year 2025 outlook on Slide 23. Based on our strong year-to-date performance, we are raising full-year 2025 revenue guidance for the third time this year to a range of $965 million to $970 million, representing approximately 31% growth compared to 2024. At the midpoint, this represents an increase of $47.5 million versus our prior range.

我們預計核心業務在第四季以及2026年全年及以後將保持正自由現金流。本季末，我們持有約 6.9 億美元的現金、現金等價物和受限現金。接下來請看第 23 頁投影片，了解 2025 年全年展望。鑑於我們今年迄今的強勁業績，我們將 2025 年全年營收預期第三次上調至 9.65 億美元至 9.7 億美元之間，與 2024 年相比成長約 31%。中點值比我們之前的預期範圍增加了 4750 萬美元。

We now expect oncology revenue to grow approximately 25% year over year, up from prior guidance of 20%, driven by stronger-than-expected oncology volumes in the third quarter and higher expected volumes for the remainder of the year. We now forecast total oncology test volume to grow more than 30% compared to our previous expectation of greater than 27%. Our biopharma and data business remains on track to deliver mid-teens growth for the full year. We are also increasing our Shield revenue guidance to $71 million to $73 million, up from $55 million to $60 million, reflecting higher expected volume of 80,000 to 82,000 tests compared to prior guidance of 68,000 to 73,000 tests.

我們現在預計腫瘤業務收入將年增約 25%，高於先前 20% 的預期，這主要得益於第三季腫瘤業務量強於預期，以及預計今年剩餘時間業務量將有所增長。我們現在預測腫瘤檢測總量將增加超過 30%，而我們先前的預期是成長超過 27%。我們的生物製藥和數據業務仍有望實現全年兩位數中段的成長。我們同時將 Shield 的營收預期從 5,500 萬至 6,000 萬美元上調至 7,100 萬至 7,300 萬美元，這反映出預計檢測量將達到 8 萬至 8.2 萬次，高於先前預期的 6.8 萬至 7.3 萬次。

With continued improvement in gross margins, we are raising our full-year non-GAAP gross margin guidance to 64% to 65%, up from 63% to 64%. As previously outlined, we plan to reinvest incremental screening gross profit to accelerate commercial expansion. Accordingly, we now expect 2025 non-GAAP operating expenses to be in the range of $865 million to $875 million, representing a 14% to 16% increase compared to 2024. Finally, with our long-term financial roadmap, we remain committed to reducing cash burn each year and achieving company-wide cash flow breakeven by 2027. For the full year 2025, we continue to expect free cash flow burn of $225 million to $235 million, an improvement from $275 million in 2024. Turning to Slide 24.

由於毛利率持續改善，我們將全年非GAAP毛利率預期從63%至64%上調至64%至65%。如前所述，我們計劃將新增的篩選毛利再投資，以加速商業擴張。因此，我們現在預計 2025 年非 GAAP 營運費用將在 8.65 億至 8.75 億美元之間，比 2024 年成長 14% 至 16%。最後，根據我們的長期財務路線圖，我們仍然致力於逐年減少現金消耗，並在 2027 年實現公司整體現金流收支平衡。對於 2025 年全年，我們繼續預期自由現金流消耗為 2.25 億美元至 2.35 億美元，較 2024 年的 2.75 億美元有所改善。翻到第24張投影片。

We began 2025 with an ambitious set of strategic and operational objectives. Through our strong execution, we have delivered on nearly all of them, and we expect continued momentum as we close out the year. Our progress this quarter positions Guardant Health, Inc. for sustained success in 2026 with continued oncology volume growth and strong Shield adoption. With that, we will now open the call for questions.

2025 年伊始，我們制定了一系列雄心勃勃的策略和營運目標。憑藉我們強而有力的執行力，我們幾乎實現了所有目標，我們預計在年底前將繼續保持這一勢頭。本季的進展使 Guardant Health, Inc. 在 2026 年能夠持續取得成功，腫瘤業務量將持續成長，Shield 也將廣泛應用。接下來，我們將開始接受提問。

Thank you. We will now begin the Q&A session. (Operator Instructions)

謝謝。現在開始問答環節。（操作說明）

Bradley Bowers, Mizuho.

Bradley Bowers，瑞穗銀行。

Hey, there. Thanks for the question. A strong performance across the businesses, but I am going to focus on Shield here. Was wondering if you could walk us through kind of the Shield ASP dynamics exiting the year. Continued strong pricing, I think it is surprising given the ADLT pricing, but that $900 we are kind of exiting the year at. It is supposed to walk down to $700 by 2028. I know there are some mix implications there, but is it kind of a steady degradation? Is there a fallout expected as ADLT pricing kind of rolls off the initial phase at the end of this year? Any color on the phasing of that would be helpful. Thank you.

嘿。謝謝你的提問。各業務部門表現強勁，但我將專注於 Shield 業務。我想請您為我們介紹一下Shield在今年年底的平均售價（ASP）動態。考慮到 ADLT 的定價，我認為價格持續走強令人驚訝，但我們今年的收官價是 900 美元。預計到 2028 年價格將降至 700 美元。我知道這其中存在一些混合影響，但這算是一種持續惡化的過程嗎？隨著 ADLT 定價機制在今年年底結束初始階段，是否預計會出現一些負面影響？如果能提供一些關於相位的資訊就更好了。謝謝。

Yes, Brad. This is Mike. I can take that. I mean, to break down the Shield ASP, you know, we have the Medicare rates at $1,495 that came into play at the start of the second quarter. We are also receiving really good payment from Medicare Advantage payers. And so when they are paying us, they are paying us at this $1,495 rate also. And at the moment, the majority of our volume is skewed towards Medicare and Medicare Advantage. And then we have a tranche of commercial patients, and we are effectively getting paid more or less zero for those.

是的，布拉德。這是麥克。我可以接受。我的意思是，要分析 Shield 的平均銷售價格，你知道，我們有 Medicare 的費率，該費率為 1,495 美元，從第二季初開始生效。我們也從聯邦醫療保險優勢計劃的支付方那裡獲得了非常可觀的付款。所以，當他們付錢給我們的時候，也是以1495美元的費率支付給我們。目前，我們的大部分業務量都集中在聯邦醫療保險和聯邦醫療保險優勢計劃上。此外，我們還有一部分商業病人，但我們實際上從這些病人身上幾乎沒有任何報酬。

And so as we look at over the next few years, we are very confident in the $1,495 ADLT rate going forward. And in fact, we have just submitted our package back to Medicare on the date of submission of the pricing over the last six months, and that should help us maintain this $1,495 rate now, at least for the next two years. Going forward, also, we expect Medicare Advantage to continue to be strong. In fact, we would hope that it can get stronger than where it is today.

因此，展望未來幾年，我們對 1,495 美元的 ADLT 稅率非常有信心。事實上，我們剛剛將過去六個月的定價方案提交給了聯邦醫療保險，這應該有助於我們至少在未來兩年內維持 1,495 美元的費率。展望未來，我們預計聯邦醫療保險優勢計劃將繼續保持強勁勢頭。事實上，我們希望它能比現在更強大。

The fluctuation over the next couple of years is going to be the percentage of commercial payer patients that we have and how quickly we can ramp up the commercial reimbursement there. And so we are assuming in 2028, there is just a higher proportion of commercial patients in the mix. It is going to take us time to sort of establish that reimbursement rate. But overall, we are really happy with where the ASP is today, and we think it bodes well for as we go into 2026 and beyond.

未來幾年的波動將取決於我們商業保險患者的比例以及我們提高商業保險報銷速度的能力。因此我們假設到 2028 年，商業患者的比例會更高。我們需要一些時間來決定報銷率。但總的來說，我們對目前的平均售價 (ASP) 非常滿意，我們認為這預示著 2026 年及以後會有良好的發展前景。

Doug Schenkel, Wolfe Research.

道格‧申克爾，沃爾夫研究中心。

Hey, good afternoon and thank you for taking my question. So another question on Shield. You mentioned at the Investor Day, and as well as in your prepared remarks that potential ACS guideline inclusion later this year could set the stage for commercial coverage in, I think, at least 10 states. And we believe Anthem and other large blues are watching closely. So to the best of our knowledge, ACS concluded their CRC screening guidelines review earlier this month. With that in mind, is guideline inclusion at this point a real possibility by year-end with ACS?

您好，下午好，感謝您回答我的問題。那麼，關於Shield還有另一個問題。您在投資者日以及您事先準備好的發言中都提到，今年稍後美國癌症協會 (ACS) 指南的潛在納入可能會為至少 10 個州的商業保險鋪平道路。我們相信 Anthem 和其他大型藍調樂團都在密切關注著事態發展。據我們所知，美國癌症協會 (ACS) 已於本月初完成了 CRC 篩檢指南的審查。考慮到這一點，在年底前將 ACS 納入指南是否真的有可能？

And then once guidelines are in place, how long do you think it is going to take for that to translate into you actually getting paid? Then the final component of the question is, beyond those initial 10 or so states, there are other states like Florida and Louisiana where mandates have been brought in to include ACS as well as NCCN in addition to USPS. So if we think about that broader universe of states, which I think maybe gets you closer to 17, is it likely that reimbursement could occur not just in the initial 10%, but closer to 20 over the next year or so? Thank you.

那麼，一旦相關準則出台，你認為需要多久才能真正轉化為你獲得報酬？那麼，問題的最後一個組成部分是，除了最初的 10 個左右的州之外，還有像佛羅裡達州和路易斯安那州這樣的其他州，這些州已經強制要求將 ACS 和 NCCN 以及 USPS 納入其中。所以，如果我們考慮更廣泛的州範圍，我認為可能會接近 17 個州，那麼在未來一年左右的時間裡，是否有可能不僅在最初的 10% 的情況下進行報銷，而且在接近 20% 的情況下進行報銷呢？謝謝。

Thank you, Doug, for your question. Yeah. You know, based on what we know, it appears that ACS research team is almost done with their work. So we remain confident about this potential for Shield to be included in the near future. We are monitoring the situation very closely, but we are very optimistic about that. In terms of the guide, like, you know, it is not part of this year guide. We are not counting on any kind of upside associated with the ACS guideline. And, you know, it is going to take some time.

謝謝你的提問，道格。是的。根據我們目前掌握的情況來看，ACS 研究團隊似乎已經接近完成他們的工作了。因此，我們仍然對Shield在不久的將來被納入其中充滿信心。我們正在密切關注事態發展，但我們對此非常樂觀。至於指南方面，你知道，它不屬於今年的指南。我們並不指望 ACS 指南會帶來任何好處。你知道，這需要一些時間。

When we go into the guideline, it gives us initially some upper hand, and it should have a strong it should have a positive impact on our appeal success rate. Initially. And then at some point, you know, that would result in product coverage and contracting successes. I am proud of what our team has achieved so far in trying to broaden access to Shield, you know, just Florida, now you know, through a consortium of, you know, supporters of making sure that innovative technology becomes accessible. Now, for instance, Medicaid patient population in Florida have access to tests like Shield, and we are very proud of that.

當我們遵循指導原則時，它最初會給我們帶來一些優勢，並且應該會對我們的上訴成功率產生積極的影響。最初。然後，在某種程度上，你知道，這將帶來產品覆蓋範圍和合約簽訂的成功。我為我們團隊迄今為止在擴大 Shield 的普及範圍方面所取得的成就感到自豪，你知道，目前只是在佛羅裡達州，現在你知道，這是透過一個聯盟實現的，你知道，該聯盟由一些支持者組成，旨在確保創新技術能夠普及。例如，現在佛羅裡達州的醫療補助患者群體可以獲得像 Shield 這樣的檢測，我們為此感到非常自豪。

And in general, we are very pleased with some of the positive and regular dialogue that even we have with the admin about their priorities around cancer screening, around prevention, around making America healthy. And I am excited. That looks like both the president and secretary are looking for ways to see how maybe the rate of cancer can get reduced in the country and how could we try to bring innovations to patients in a faster way. But we will see what happens, but, obviously, we are not counting on any of those successes. In our drive at this time.

總的來說，我們對與政府就癌症篩檢、預防和保障美國民眾健康等優先事項進行的一些積極且定期的對話感到非常滿意。我很興奮。看來總統和部長都在尋找降低該國癌症發病率的方法，以及如何更快地將創新療法帶給患者。但我們會拭目以待，不過很顯然，我們並沒有期待這些成功。此刻我們正在開車。

Puneet Souda, Leerink Partners.

Puneet Souda，Leerink 合夥人。

Yes. Thanks for taking my questions. Really impressive quarter here and really strong guide. If I may, AmirAli, first one on Shield. Just growth is accelerating on volumes, rightfully so, new product and ASP is also up. Should we think about 2026 growth for Shield and any early reception details that you can talk about on the MCD side? What is sort of the early attach rate? And for Helmy, it has been almost a decade since you launched G360 when it appeared on the market for the first time. It is really impressive to see ten years later, this product is growing 30% plus.

是的。謝謝您回答我的問題。本季表現非常出色，而且是一條非常強勁的指導方針。如果可以的話，AmirAli，Shield 上的第一個。銷售成長加速，理所當然，新產品和平均售價也有所上漲。我們是否應該考慮一下 Shield 在 2026 年的成長情況，以及您在 MCD 方面可以談談的任何早期回饋細節？早期附著率大概是多少？對 Helmy 來說，距離 G360 首次上市已經過了近十年。十年後，這款產品仍維持著30%以上的成長率，真是令人印象深刻。

Maybe just talk to us about what is behind that and how should we think about growth going forward here for the Liquid G360, which has been impressive? Thank you.

或許您可以和我們談談背後的原因，以及我們該如何看待 Liquid G360 的未來發展，它的表現令人印象深刻？謝謝。

Maybe I will make the Shield part quick so I can talk to you about the oncology side. So as you have seen, we consistently raised our outlook throughout this year. We are very pleased with what we are seeing, the momentum that we are seeing. We want to be thoughtful and not get ahead of our skis. So, you know, I think still it is too early for us to comment about 2026. At the right time, we will talk about it, but we continue to be very confident about the long-term, you know, outlooks that we shared in our Investor Day.

或許我會盡快完成 Shield 部分，這樣我就可以和你談談腫瘤學方面的事情了。正如您所看到的，我們今年一直在不斷提高預期。我們對目前所看到的情況和發展勢頭感到非常滿意。我們希望謹慎行事，不要操之過急。所以，你知道，我認為現在對 2026 年發表評論還為時過早。時機成熟時，我們會討論這個問題，但我們仍然對我們在投資者日上分享的長期前景充滿信心。

Yeah. No. We are very pleased with the performance, and Sachiv, eleven years and counting in from when we launched in 2016. So to see it grow at this rate, you know, I think at this point in the product cycle, is really pleasing, but I think it is sort of what we expected in the sense that many people think of this as a test and they pattern match it to, you know, other tests in the market. But it truly is an application platform.

是的。不。我們對業績非常滿意，Sachiv 自 2016 年推出以來已經走過了十一年，而且還在繼續發展。所以看到它以這樣的速度增長，我認為在產品週期的這個階段，真的令人欣慰，但我認為這在某種程度上也是我們所預期的，因為許多人認為這是一個測試，他們將其與市場上的其他測試進行比對。但它確實是一個應用平台。

When you think about these smart apps that we are introducing and really the multiplication of clinical utility and ability and capabilities of this platform, this is just the beginning in terms of where liquid biopsy can go. I mean, that is the point of liquid biopsy is you can come in, you can test, you know, many more patients. You can increase access. But you can test them longitudinally as well. And you know, we are still at the very, very early innings in terms of where this can go with the technology can go. Just in oncology. So I think you are going to see a lot more I think, of this trajectory in the coming years.

當你想到我們正在推出的這些智慧應用程序，以及該平台臨床實用性、能力和功能的巨大提升時​​，你會發現這只是液體活檢發展方向的開始。我的意思是，液體活檢的意義就在於，你可以來這裡，你可以檢測，你知道，更多的病人。您可以增加存取權限。但你也可以對它們進行縱向測試。你知道，就這項技術的發展前景而言，我們目前還處於非常非常早期的階段。僅限於腫瘤科。所以我認為，在未來幾年裡，你會看到更多這樣的發展軌跡。

As we continue to expand on the capabilities of Guardant360 over the next decade.

在接下來的十年裡，我們將繼續擴展 Guardant360 的功能。

Subbu Nambi, Guggenheim.

蘇布南比，古根漢美術館。

Thank you for taking my question. If you were to put a timeline if we were to put a timeline to NCD FDA approval based on Shield trajectory next year, would FDA submission for MCD in late 2027 be a reasonable expectation?

感謝您回答我的問題。如果要根據 Shield 的進展軌跡，為 NCD 獲得 FDA 批准設定時間表，那麼在 2027 年底向 FDA 提交 MCD 申請是否是一個合理的預期？

For MCD, you know, we just actually broadened access, and we just actually started getting access to this kind of clinical data that I talked about. During our Investor Day and the prepared remarks. So we need to monitor it and see how quickly we can build that evidence. But we are very optimistic that potentially through the way that we are doing, we can get access to hundreds of thousands of patients' data and monitor actually the impact of MCD testing in the clinical value, performance, safety. It is still too early for us to specifically put a timeline for FDA approval.

對於 MCD，你知道，我們實際上擴大了獲取途徑，並且我們實際上開始獲得我剛才提到的那種臨床數據。在我們的投資者日活動和準備好的發言稿中。所以我們需要密切關注，看看我們能以多快的速度收集相關證據。但我們非常樂觀地認為，透過我們正在採取的方式，我們有可能獲得數十萬名患者的數據，並實際監測 MCD 檢測在臨床價值、效能和安全性方面的影響。現在就確定FDA批准的具體時間表還為時過早。

But we would monitor the situation closely and as we get more confidence, maybe we can talk about it at the right time. Perfect.

但我們會密切關注情勢，隨著信心的增強，或許我們可以在適當的時機討論這個問題。完美的。

Thank you, guys.

謝謝大家。

Patrick Donnelly, Citi.

派崔克唐納利，花旗銀行。

Hey guys. Thank you for taking the questions. Helmy, maybe one for you on Reveal. I know in the past, you have talked about driving the test per patient higher. Can you just talk about the traction there given the bigger push internally? What kind of progress you are seeing? Where can that go? Over the relative near term? And I know during the prepared remarks, you talked about obviously the ongoing studies, the additional tumor types, just talk about what we should be looking for and the key catalysts on the REVEAL side here the next couple of quarters to keep an eye on? Thank you.

嘿，大家好。感謝您回答這些問題。Helmy，或許Reveal上有個適合你的。我知道你過去曾談到要提高每位患者的檢測次數。鑑於內部更大的推動力，您能否談談這方面的進展？你看到了哪些進展？那會去哪裡？短期內呢？我知道在事先準備好的演講稿中，您談到了正在進行的研究、新增的腫瘤類型，請談談我們應該關注哪些方面，以及在接下來的幾個季度裡，REVEAL 研究方面有哪些關鍵的催化劑需要關注？謝謝。

Yes. Great question. I think we said at the beginning of the year, as we got the surveillance indication from a reimbursement point of view for Reveal that would be turning on a lot of the sort of capabilities to be able to pull in subsequent test orders and so on and you know, I am pleased to report that, you know, we have put a lot of those in place, and we are seeing some of the benefits of that and the return on investment there.

是的。問得好。我想我們在年初就說過，從報銷的角度來看，隨著我們對 Reveal 的觀察，我們將啟用很多功能，以便能夠獲得後續的測試訂單等等。我很高興地報告說，我們已經落實了很多這樣的功能，並且正在看到一些好處和投資回報。

So we know we can pull in subsequent orders now in a sort of very straightforward way and so that is going to pay dividends across our blood-based portfolio as we think about the emergence and really, the place where longitudinal testing will sit in terms of management of patients in oncology with things like Serena six in terms of ESR1 with the upcoming launch for therapy monitoring, based on REVEAL. And then, obviously, with REVEAL itself in the MRD setting, recurrence monitoring. Setting. So yeah, really great progress. The number of tests per patient has gone up pretty nicely, and we are still, I would say, very much in the early cycles of really capitalizing on that investment.

所以我們知道，現在我們可以以非常直接的方式獲得後續訂單，這將為我們基於血液的產品組合帶來回報，因為我們正在考慮縱向檢測的出現，以及縱向檢測在腫瘤患者管理中的地位，例如即將推出的基於 REVEAL 的 ESR1 治療監測產品 Serena Six。然後，很顯然，在 MRD 設定中，REVEAL 本身可以用於復發監測。環境。是的，進展非常順利。每位患者的檢測次數已經顯著增加，我認為我們仍然處於真正利用這項投資的早期階段。

Tycho Peterson, Jefferies.

泰科·彼得森，傑富瑞集團。

Hey, thanks. I would love to hear your views on the Pegasus data and just kind of how you think about that. Having kind of any impact on just MRD-driven therapy management? And then how are you thinking about clinical utility evidence in general? And NCCN guidelines?

嘿，謝謝。我很想聽聽你對飛馬座數據的看法，以及你對此的想法。對僅以微小殘留病灶（MRD）為導向的治療管理有任何影響嗎？那麼，您整體上是如何看待臨床實用性證據的？NCCN指南呢？

Yes. Pegasus was an interesting study. It was a phase two signal finding study, and you know, I think there are a few things that showed that I think were exciting to me, is the fact that you could spare something like 75% of patients from chemotherapy, which meant, you know, huge, huge reduction in terms of neurotoxicity and other toxicities related to such really harsh chemotherapy. And so I think you know, Pegasus is based on our previous version of REVEAL. And so I think we are really looking forward to track c, which is based on a newer version.

是的。飛馬號的研究很有趣。這是一項二期訊號發現研究，你知道，我認為有幾件事讓我感到興奮，那就是它可以使大約 75% 的患者免於化療，這意味著，你知道，神經毒性和其他與這種非常強烈的化療相關的毒性將大幅減少。所以我想你應該知道，Pegasus 是基於我們之前的 REVEAL 版本開發的。所以我覺得我們非常期待基於新版本的 Track c。

And really, the field, you know, having larger datasets to really understand exactly you know, where the threshold should be in terms of you know, escalation and de-escalation in terms of patients. But, you know, I think it is clear that I think there can be a lot of benefit by using, you know, this additional data in terms of ctDNA in the adjuvant and surveillance settings. But I think this is a good foundation and one that we can build on. As we continue investing in both clinical validity and clinical utility studies around our Reveal platform.

實際上，該領域需要更大的數據集才能真正了解，在患者病情升級和降級方面，閾值應該在哪裡。但是，你知道，我認為很明顯，利用 ctDNA 的這些額外數據，在輔助治療和監測環境中，可以帶來許多好處。但我認為這是一個很好的基礎，我們可以以此為基礎繼續發展。我們將繼續投資於圍繞 Reveal 平台的臨床有效性和臨床實用性研究。

Bill Bonello, Craig-Hallum.

比爾·博內洛，克雷格-哈勒姆。

Hey guys. I just want to push a little deeper on Sunit's third question about the growth in Guardant360. Could you just give us some sense today? I mean, we think about what is out there that is driving, there is the underlying growth, there is the fact that you are probably taking share. But I am also curious about sort of where we stand today in terms of a paradigm shift to liquid first or perhaps to combination testing with liquid and solid tumor. And then to what extent we are seeing some of the repeat testing that you are talking about or the use of 360 for monitoring?

嘿，大家好。我想就 Sunit 提出的關於 Guardant360 成長的第三個問題再深入探討一下。今天您就不能跟我們講點道理嗎？我的意思是，我們會思考是什麼在推動這一切，有潛在的成長，也有你可能正在搶佔市場份額的事實。但我也很好奇，就目前而言，我們處於怎樣的典範轉移階段，是先進行液體腫瘤檢測，還是進行液體腫瘤和實體腫瘤的聯合檢測。那麼，我們目前在多大程度上看到了您所說的重複測試，或者在多大程度上看到了360度監控的應用？

Just trying to get a sense of what inning we are at in terms of some of these new growth drivers and how much of that is still in front of us?

我只是想了解一下，就這些新的成長動力而言，我們目前處於哪個階段，以及還有多少成長動力等待我們去實現？

Yes. Great, great question. So we are still very early even in the penetration of liquid biopsy in terms of, you know, one test per lifetime. And so given, you know, the capabilities of 360 right now, they are just kind of mind-blowing to a lot of physicians just in terms of, you know, the depth, the sensitivity, the application space. We see that growth in just that initial setting. So that means not only market growth, but we are seeing from what we can see, significant share gains as well as a result. Then there are other growth drivers we are seeing. The fact that concurrent testing will likely become the standard of care of both tissue and liquid.

是的。非常好的問題。所以，即使就一生一次的檢測而言，液體切片的普及程度仍然很低。因此，鑑於 360 度全景影像技術目前的強大功能，對於許多醫生來說，無論是在深度、靈敏度還是應用領域方面，都令人嘆為觀止。我們僅在初始階段就看到了這種成長。所以這意味著不僅市場成長，而且從我們目前所看到的來看，市場佔有率也會大幅成長。此外，我們還看到了其他一些成長驅動因素。同時進行組織和液體檢測很可能成為標準治療方法。

And so that is also another sort of growth driver and starting to see that really take off. And then finally, the test for patients. And so we estimate, at maturation that we should be able to go from one test per patient per lifetime to something like four and a half or four or five tests per patient per year which, you know, obviously means more than, you know, probably doubling of where the market is today. Sorry. More than a 10x in terms of where the market is today.

所以這也是另一種成長動力，而且我們開始看到它真正起飛了。最後，是患者檢測。因此我們估計，技術成熟後，我們應該能夠將每位患者一生的檢測次數從一次提高到每位患者每年四次半、四次或五次，這顯然意味著市場規模可能會翻倍以上。對不起。比目前的市場水準高出十倍以上。

And so that is really exciting in terms of where things are going, and this is things like Serena's six in terms of ESR1, longitudinal monitoring, therapy monitoring, the data that we have with IO monitoring, with chemo monitoring, and so on. All of that will feed into essentially establishing, this new paradigm of, essentially monitoring patients with ctDNA. We are already seeing our biopharma partners use this type of testing in their phase one, phase two, phase three studies, using it to decide do they sort of scale phase one to phase two?

所以，就事情的發展方向而言，這真的很令人興奮，例如小威的六歲，ESR1，縱向監測，治療監測，我們擁有的IO監測數據，化療監測數據等等。所有這些都將有助於建立這種新的範式，即利用 ctDNA 監測患者。我們已經看到我們的生物製藥合作夥伴在他們的一期、二期、三期研究中使用這種類型的測試，以此來決定他們是否將一期試驗擴展到二期試驗？

Using it for dosing, and so that is the other piece that I think is not very well appreciated is that a lot of tests you launch them they are used exactly the same way ten years later or fifteen years later and so on. They only have sort of one function. The application space and utility of how you use something like Guardant360 and Guardant Reveal is really multiplying quarter by quarter and year by year. And so, yeah, this is a true platform. That word is often overused. But this is a true platform.

將其用於劑量控制，而我認為另一個沒有得到充分重視的方面是，你進行的許多測試，在十年或十五年後，其使用方式仍然完全相同。它們似乎只有一種功能。Guardant360 和 Guardant Reveal 等產品的應用範圍和實用性確實在逐季逐年地成長。所以，是的，這是一個真正的平台。這個詞經常被濫用。但這確實是一個平台。

And you are seeing what that means in terms of our volume growth and you know, the trajectory that we laid out at our Investor Day.

而你們現在看到的，正是我們銷售成長所取得的成就，以及我們在投資人日上所製定的發展軌跡。

Michael Ryskin, Bank of America.

邁克爾·里斯金，美國銀行。

Hi, thank you for taking the question. This is Aaron on for Mike. I wanted to dive into Reveal volumes in specifically Reveal versus Ultra and how you guys are thinking about the R&D investment needed in both of those assets? And then the second part of that is MRD is still a fairly open space. 10% penetrated, what people are saying. So I guess, how are you guys looking at the market? How are you guys looking at growth? And how should we be expecting both of those assets to grow over the next three years? Thank you.

您好，感謝您回答這個問題。這是亞倫替麥克報道。我想深入探討 Reveal 的發行量，特別是 Reveal 與 Ultra 的發行量對比，以及你們如何看待這兩種資產所需的研發投入？其次，MRD市場仍處於相當開放的階段。據人們所說，市場滲透率只有10%。所以我想問，你們如何看待市場？你們如何看待成長？那麼，我們該如何預期這兩項資產在未來三年內的成長情況呢？謝謝。

Yes. We are very excited about our MRD franchise. Reveal is, you know, the leading tissue-free MRD test in the market. We know that there will be essentially two parts of the market that will be important: the tissue-free side and the tumor-informed side of things. And, you know, we are very pleased in terms of where we sit in the tissue-free side. It is our fastest-growing product in oncology. And, you know, the amount of data, the amount of investments, you know, we have a 10x sort of data generation, planned as we presented before. Next year. And so, you know, that flywheel is really sort of chugging away. And so we are excited about that trajectory.

是的。我們對我們的 MRD 特許經營權感到非常興奮。Reveal是目前市場上領先的無組織MRD檢測產品。我們知道，市場基本上會分為兩個重要部分：無組織部分和腫瘤資訊部分。你知道，就我們目前在無紙巾領域所處的位置而言，我們非常滿意。它是我們腫瘤領域成長最快的產品。你知道，數據量、投資額，你知道，我們計劃將數據生成量提高 10 倍，正如我們之前所展示的那樣。明年。所以，你知道，那個飛輪一直不停地轉動。因此，我們對這一發展軌跡感到興奮。

And then you know, in terms of the tumor-informed side, I think we agree with you. There is, you know, kind of a lot of opportunity there. In terms of a, you know, test that can really hit the needs of both biopharma and clinicians in terms of sensitivity better really acquired for that setting. And, yeah, we are just very pleased with the technology that we have developed. You know, think about it, just everything we have built as a company sort of is at a really nice point.

然後，你知道，就腫瘤相關因素而言，我想我們同意你的觀點。你知道，那裡有很多機會。你知道，就測試而言，它能夠真正滿足生物製藥公司和臨床醫生的需求，在靈敏度方面，並更好地適應這種環境。是的，我們對我們開發的技術非常滿意。你知道，想想看，我們公司所取得的一切成就現在都處於一個非常好的階段。

You know, the fact that we have really chugging away on our tissue volumes and the capabilities we have with using very low amounts of input material, very fast turnaround times. The sensitivity we have on the liquid biopsy side and the capabilities, bugs down and the speed to results, all of that is coming together in Reveal Ultra. And I think it is going to be a product that will, frankly, blow everyone away once we launch it. Very excited for that and making really good progress.

你知道，我們一直在努力提高組織產量，並且能夠以非常少的輸入材料實現非常快速的周轉時間。Reveal Ultra 將液體活檢的靈敏度、功能、故障率和結果速度完美地融合在一起。坦白說，我認為這款產品一旦上市，一定會讓所有人感到驚艷。對此我感到非常興奮，而且進展非常順利。

Daniel Barkowitz, Evercore ISI.

丹尼爾·巴科維茨，Evercore ISI。

Mark Massaro, BTIG.

馬克·馬薩羅，BTIG。

Hey guys, thanks for taking the questions. The first one is for you, AmirAli. Just looking at the Shield, it is great to see this trajectory. Is it reasonable to think in the near term that 1,000 sequential increase from the prior quarter is the right way to think about this just looking at the Q4 implied guide at the high end, it is plus 9%. You just did plus eight prior quarter, seven. Or so I guess I am asking if this is a reasonable run rate in the near term. Or do you think there is obviously upside from partnerships with Quest, PathGroup, you know, certainly guideline inclusion and potential DTC uplift? So that is my first part.

各位好，感謝你們回答問題。第一封是給你的，AmirAli。單看Shield的表現，就能看到這樣的發展軌跡，真是太棒了。短期內，認為比上一季季增 1000 人是否合理？僅從第四季隱含的業績指引來看，最高可達 9%。你剛完成了上個季度的八分之一，也就是七分之一。或者說，我真正想問的是，這樣的運行速度在短期內是否合理。或者您認為與 Quest、PathGroup 等公司合作顯然會帶來好處，例如納入指南和潛在的 DTC 提升？這是我的第一部分。

The second part is for Helmy. Helmy, can you just give us a sense for Reveal Ultra? I believe this is the tumor-informed that can go down to one part per million. Just give us a sense for maybe if you could clarify if that is commercially launched now and how we should think about the timing of CMS reimbursement and additional data readouts? Thanks.

第二部分是給赫爾米的。Helmy，可以簡單介紹一下 Reveal Ultra 嗎？我相信這是腫瘤相關的，其濃度可以低至百萬分之一。能否請您簡要說明一下，該產品目前是否已正式上市，以及我們應該如何看待 CMS 報銷時間和後續資料發布的時間安排？謝謝。

Thanks, Mark. So in terms of sequential growth, like our guide, what has ended in the midpoint is, like, another 8,000. Q over q growth in Q4. We are going to monitor the situation closely. And again, we do not want to get ahead of our skis and what is going to happen. Next year, we are going to talk about it at the right time. There are a bunch of catalysts, you know, still in front of us. You know, there is Quest, PathGroup, collaboration should be a positive thing. Guideline inclusion is definitely a positive thing. You know, continuous build-out of our own commercial team as we go into next year would be a positive thing.

謝謝你，馬克。所以就連續成長而言，就像我們的指南一樣，到中點時，大約又增加了 8,000。第四季Q值較q值成長。我們將密切關注事態發展。再次強調，我們不想操之過急，也不想預測會發生什麼事。明年，我們會在適當的時機討論這個問題。你知道，我們面前還有很多催化劑需要克服。你知道，有 Quest、PathGroup，合作應該是件好事。納入指南絕對是件好事。你知道，隨著我們進入明年，不斷壯大我們自己的商業團隊將是一件好事。

So and we are confident about the target that we put out there for 2028. So but we go at it one step at a time. And we are very excited to see what is going to happen in Q4.

所以，我們對2028年設定的目標充滿信心。所以，我們一步一步來。我們非常期待第四季將會發生什麼。

Yeah. In terms of Reveal Ultra, you know, I think the nice thing is we built such, you know, strong capabilities around MRD. When you think about the R&D and all the clinical studies, you know, tens of thousands of samples and many of those, we have actually retained tissue. So it is actually, you know, not, you know, very heavy investment for us to essentially leverage that to really come out with the sort of ultra technology, the tumor-informed technology we have. We are seeing really good data. Really excited in terms of where this can go.

是的。就 Reveal Ultra 而言，我認為它的優點在於我們圍繞 MRD 建立瞭如此強大的能力。當你想到研發和所有臨床研究時，你知道，成千上萬個樣本，其中許多樣本我們都保留了組織。所以實際上，你知道，對我們來說，利用這種技術來真正推出我們所擁有的這種超先進技術——腫瘤資訊技術——並不需要非常大的投資。我們看到的數據非常好。我對這個計畫的未來發展方向感到非常興奮。

In terms of the sensitivity, we think it can bring it down to a much lower level than exists in the field or, frankly, exists in the pipeline of companies we have seen out there. And I would say that you know, in terms of timing, we are keeping that close to the chest. So stay tuned. But, making good progress and we wouldn't be talking about it if it was not something that, you know, was not in the too distant future.

就敏感度而言，我們認為它可以將其降低到比目前領域或坦白說，比我們所見過的公司正在研發的產品的敏感度低得多的水平。至於時間安排，我們目前仍處於保密階段。敬請期待。但是，目前進展順利，如果不是因為這件事距離我們還有很長的路要走，我們也不會在這裡討論它。

Casey Woodring, JPMorgan.

Casey Woodring，摩根大通。

Great, thanks for taking my questions. On the shield performance in the quarter, maybe as a follow-up to to Mark's question, can you provide any KPIs around maybe average testing frequency per physician and whether volumes are coming from new new time CRC screeners? And then, just my second question here, like, if you can provide any color on gross margin for shield and reveal embedded in the updated guide of 64% to 65% for this year, that'd be helpful.

太好了，謝謝你回答我的問題。關於本季的盾牌表現，或許可以作為對 Mark 問題的後續，您能否提供一些關鍵績效指標，例如每位醫生的平均檢測頻率，以及檢測量是否來自新的 CRC 篩檢人員？然後，我的第二個問題是，如果您能提供一些關於今年更新後的 64% 到 65% 的指導方針中嵌入的盾牌和揭示毛利率的信息，那就太好了。

Thank you.

謝謝。

Yeah, maybe some KPI is actually it's exciting that the breadth of ordering continues to increase Que over Q. The depth of ordering continues to be very strong. So once the accounts actually start using shield and we go through activation, the depth of ordering is very solid, which is really an endorsement of how deep this market is and mainly how many on-screen cancer patients are out there. In the accounts that we are going to, so we are seeing their doctors, we are successfully bleeding them and so forth. So the other KPI to share, which we are very excited about is we continue to see very high adherence rates when the doctors order this stuff, more than 90% of those gets converted to a sample received in our lab, which really gives us a bunch of efficiencies in our S&M investments.

是的，或許某些關鍵績效指標（KPI）確實令人興奮，因為訂單廣度持續成長（Que 大於 Q）。訂單深度也依然非常強勁。因此，一旦帳戶真正開始使用 Shield 並完成激活，訂單量就非常穩定，這確實證明了這個市場的深度，以及螢幕上顯示的癌症患者數量之多。在我們即將接觸的案例中，我們會去看他們的醫生，我們會成功地給他們放血等等。另一個讓我們非常興奮的 KPI 是，當醫生開立這類藥物時，我們持續看到非常高的依從率，其中超過 90% 的藥物被轉化為我們實驗室收到的樣本，這確實提高了我們在銷售和行銷投資方面的效率。

Yeah, and on the on the gross margins with shield in the prepared remarks we mentioned that the shield gross margin this quarter Q3 was 55% and so you know ASPs are close to $900 and our cost per test now is consistently lower lower than $500. So we've made really great progress with shield gross margins and then. On the reveal side again, we've made fantastic progress over the last sort of 9 months or so and just to break that out a bit how ASPs are revealed continue to be in the $600 to $700 dollar range and again since the start of the year our reveal costs per test are consistently below.

是的，關於Shield的毛利率，我們在準備好的發言稿中提到，Shield本季（Q3）的毛利率為55%，所以你知道，平均售價接近900美元，而我們每次測試的成本現在持續低於500美元。所以我們在盾牌毛利率方面取得了非常大的進展，然後。在產品展示方面，我們在過去大約 9 個月中取得了巨大的進步。具體來說，ASP 的展示價格仍然在 600 到 700 美元之間，而且自年初以來，我們每次測試的展示成本一直低於這個水平。

Consistently below $500 so we have a we have a nice gross margin on reveal. It's a little bit lower than the 55% we've got on shield, but they're really what's helping drive our overall lending growth margin, and we've seen the positive impact on that going from 63% in Q3 last year to 66%. So I think good progress across the board with with gross margin.

始終低於 500 美元，因此我們在揭曉價格時可以獲得不錯的毛利率。雖然比我們目前在 Shield 上的 55% 略低，但它們確實是推動我們整體貸款成長利潤率的主要因素，我們已經看到這一積極影響從去年第三季度的 63% 增長到 66%。所以我認為毛利率方面整體都取得了良好進展。

Kyle Mikson, Canaccord.

Kyle Mikson，Canaccord。

Guys. Thanks for the questions. Congrats on the quarter. On REVEAL, is it possible you get ADLT status and breast Medicare coverage by the end of this year? Is that more likely a 2026 milestone? And then secondly, AmirAli, had a competitor this week announced advanced adenoma sensitivity data for its colon cancer blood tests. The confidence interval lower bound was fifteen percent and the study had a lot of very small lesions. Just curious if you think that a test with AA materially higher than thirteen percent for SHIELD would pose a threat and you would like, know, one day aim to improve upon your AA data.

夥計們。謝謝大家的提問。恭喜你本季取得佳績。在 REVEAL 計劃中，是否有可能在今年年底前獲得 ADLT 資格和乳癌醫療保險覆蓋？這更有可能是2026年的一個里程碑嗎？其次，AmirAli 的競爭對手本周公布了其結腸癌血液檢測的腺瘤敏感性數據。信賴區間的下限為 15%，且研究包含許多非常小的病灶。我只是好奇，您是否認為 SHIELD 測試中 AA 值顯著高於 13% 的測試結果會構成威脅，並且您是否希望有一天能夠提高您的 AA 值數據。

Yeah. I mean, I hear you feel status. You know, still a work in progress, obviously, with the government shutdown. Sort of paused some of the discussions a little bit. And then yeah, we are still working on breast and io. We have always said, you know, probably more likely early next year, and yeah, we are still, I think, on track for that. Regarding the data disclosures, you know, it is we obviously, we applaud anybody who is trying to contribute in this difficult area. This is a hard science area. And we feel very comfortable with our leadership position. And our technology stack, our data, and what we are doing.

是的。我的意思是，我感覺你很在意自己的地位。你知道，由於政府停擺，這項工作顯然還在進行中。某種程度上，這讓一些討論暫時中斷了一下。是的，我們仍在研究乳腺和IO。我們一直都說，你知道，可能更有可能在明年初，是的，我認為我們仍然在按計劃進行。關於數據揭露，我們當然讚賞任何試圖在這個困難領域做出貢獻的人。這是一個硬科學領域。我們對自己的領導地位感到非常滿意。以及我們的技術堆疊、我們的資料和我們正在做的事情。

We have seen similar results in this field now. A few times. Again, this is a hard field. It is a hard science field. And we believe we have the best tech stack, very innovative technology at home brew that gives us confidence. We have a three-year head start on CRC now. And know, probably even much longer on the multi-cancer side relative to some of these competitions. So we feel very good with our position at this time. And, definitely, there are some five activities that we are working on. We will see what happens.

目前我們已經在這個領域看到了類似的結果。幾次。這又是一個競爭激烈的領域。這是一個硬科學領域。我們相信我們擁有最好的技術棧，我們自主研發的創新技術讓我們充滿信心。我們在CRC方面已經領先三年了。而且要知道，在多癌治療方面，相對於某些比賽而言，治療時間可能還要長得多。所以，我們對目前的情況感到非常滿意。當然，我們正在進行五項活動。我們拭目以待。

Luke Sergott, Barclays.

盧克·塞爾戈特，巴克萊銀行。

Great. Thanks for the questions. Just wanted to touch here on the step up in OpEx that you guys have for the year and implied in 4Q? And really just kind of dig in where that spend, the incremental spend is going and where you guys think from an S&M perspective, where you guys want to exit the year as a number of reps as you think about Shield and Oncology and Reveal. And kind of how that you are able to pull forward any of those costs given the success you have had in some of these some of the other launches?

偉大的。謝謝大家的提問。我想在這裡談談你們今年在營運支出方面的提升，以及第四季所暗示的提升？真正深入了解一下這些支出，新增支出流向了哪裡，以及從銷售和行銷的角度來看，你們希望在今年年底前達到多少銷售代表的目標，尤其是在考慮 Shield、Oncology 和 Reveal 時。鑑於你們在其他一些產品發布中取得的成功，你們是如何提前支付這些成本的？

Yes. I mean, for the OpEx step up, it is pretty much all in the sales and marketing line. I think we have been consistent throughout the year whereby we said we are going to be reinvesting any incremental gross profit in screening back into the sales and marketing line to really drive that commercial build-out. So and we will continue to do that. I think it is the biggest focus for us. As we look to scale. We have said on the screening side, we have now got over 250 salespeople out in the field. So that is a significant ramp-up. During the year, and we will continue to look at how we build that out.

是的。我的意思是，就營運支出提升而言，幾乎全部都集中在銷售和行銷方面。我認為我們全年都堅持一個原則，那就是將篩選過程中任何新增的毛利再投資到銷售和行銷管道，以真正推動商業發展。所以，我們將繼續這樣做。我認為這是我們最關注的重點。隨著我們尋求規模化發展。我們之前說過，在篩選方面，我們現在有超過 250 名銷售人員在外奔波。所以這是一個顯著的成長。今年我們將繼續研究如何推進這項工作。

On the oncology side, it is a little bit larger than that. And we have got a very sort of well-built-out commercial infrastructure with oncology. But, yes, as we look forward and going to 2026, I think you should expect to see a similar ramp in the sales and marketing line where very focused in the R&D line and G&A line and keeping them relatively flat. So I think that is the plan for the next twelve months.

腫瘤科方面，規模大一些。我們在腫瘤學領域擁有非常完善的商業基礎設施。是的，展望未來，到 2026 年，我認為銷售和行銷部門將會有類似的成長，而研發部門和一般及行政部門則會非常注重保持相對穩定。所以我認為這就是未來十二個月的計畫。

Dan Brennan, TD Cowen

丹布倫南，TD Cowen

Great. Thank you. Congrats on the quarter. Maybe just on G360, just a couple. Maybe one for Mike and then one for Helmy. Just on the guide, I know that clinical oncology volume guide is now greater than 30. Does that contemplate like a big step down from the G360 line, which is accelerated tremendously year to date, obviously? The Q3 30%? And then B, more so for Helmy, I know you have given a lot of color on the excitement over the kind of outlook for G360. But could you give a little more color on the acceleration you have seen year to date? Is it more share gains which you talked about?

偉大的。謝謝。恭喜你本季取得佳績。或許只有G360，就那麼幾台。或許給麥克一個，再給赫爾米一個。僅從指南上看，我知道臨床腫瘤學卷號指南現在已超過 30。這是否意味著它比 G360 系列遜色很多？要知道，G360 系列今年以來的發展速度顯然非常驚人。第三季30%？還有 B，尤其是 Helmy，我知道你對 G360 的前景感到非常興奮，並對此進行了很多描述。您能否更詳細地介紹一下今年迄今為止您所看到的成長動能？您說的是更多股票收益嗎？

Like are you seeing like hospitals consolidate? Do you think it is more just penetration of CGP? Or do you think it is more like this test per patient pickup? Any way you can kind of dissect a little bit of this really strong acceleration? Thank you.

你有沒有看到醫院合併之類的現象？你認為這比較是 CGP 的滲透率嗎？還是您認為更像是依照患者人數進行檢測和取樣？你能不能稍微分析一下這種強烈的加速現象？謝謝。

Yes. Maybe I will just start on our four Q4 guide. So, you know, we had a great Q3. I think our guide for Guardant360 volume and for overall oncology volume, it implies sequential growth in Q4. It implies a very strong year-over-year growth in volume. So yes, if you back into it, it is over 30% year-over-year growth in Q4. So I think we have just continued to expect the momentum that we saw in Q3 to continue into Q4. So I think for us, things are looking very strong as we get towards the end of the year.

是的。或許我應該先開始著手準備我們的第四季業績指南。所以，你知道，我們第三季業績非常好。我認為我們對 Guardant360 銷售和整體腫瘤銷售的預測表明，第四季度將持續成長。這意味著銷量較去年同期成長非常強勁。所以，是的，如果反向推算，第四季年增超過 30%。所以我認為，我們一直預期第三季看到的成長動能延續到第四季。所以我覺得，隨著年底臨近，我們的情況看起來非常強勁。

Yes. In terms of growth driver, I think what you are seeing really is the fact that, you know, it is just a very compelling test from a value proposition. So I think a lot of what you are seeing is some of the share gains, you know, from the sort of other tests in the market from, you know, other hospitals and so on. So that has been exciting. We are seeing a little bit of the sort of, you know, increase in testing in terms of longitudinally, but I would say that is a very minor part. I think that is still a lot of that is still another, like, major growth catalyst for us.

是的。就成長動力而言，我認為你看到的實際上是，你知道，這只是一個非常有說服力的價值主張測試。所以我認為你現在看到的許多份額成長，都來自於市場上其他檢測方法的競爭，例如其他醫院的檢測等等。這真是令人興奮。我們看到縱向偵測量略有增加，但我認為這只是很小的一部分。我認為這仍然是我們另一個重要的成長催化劑。

In the future that we have not really tapped into. And then the third piece is you know, this test has so many capabilities, things like, you know, being able to determine the type of cancer, what someone who has a cancer of unknown primary, sub. So if you think about the long tail of cancers where liquid biopsies and even tissue tumor biopsies are not really utilized, the fact, you know, that we have this smart platform with epigenetics and so on that can give so much more insight into tumor biology I think you are seeing penetration into some of these longer tail of cancers as well.

在我們尚未真正探索的未來。第三點是，你知道，這項測試有很多功能，例如，能夠確定癌症的類型，對於原發灶不明的癌症患者，可以進行亞臨床診斷。所以，如果你想想那些液體活檢甚至組織腫瘤活檢都無法真正利用的癌症長尾，那麼，我們擁有表觀遺傳學等智慧平台，可以更深入地了解腫瘤生物學，我認為你也看到了它對這些癌症長尾的滲透。

One more question please, Cameron.

卡梅倫，請再問一個問題。

Daniel Arias, Stifel.

Daniel Arias，Stifel。

Yes. Good afternoon, guys. Thanks. Helmy, I just wanted to go back to REVEAL. You maybe talk about where things are on the commercial side when it comes to reimbursement and colorectal? What is a good ballpark number at this point for just the percentage of tests that are getting paid for, I guess, stage two and three patients would be the right subpopulation to ask about there. But I am really just trying to understand about for the side of CMS in your key indication there.

是的。下午好，各位。謝謝。Helmy，我只是想回到 REVEAL。您能否談談在大腸癌的報銷方面，商業領域的現況？目前，對於獲得付費的檢測比例，比較合理的估計數字是多少？我想，應該詢問的是第二期和第三期患者的這個亞群。但我其實只是想了解您提到的關鍵指標中關於 CMS 的部分。

Yeah. Dan, it is Mike here. It cut out a bit towards the end, but I think you are asking about Reveal reimbursements with CRC. CRC now is it is roughly 50% of our volume. It continues to be at that sort of level. And the rest being made at the moment from breast and lung and where we are getting reimbursed is for all of the now whenever we run a CRC test, getting reimbursed for all of these tests that we do for Medicare. And that is at the $1,640 rate. And we are getting good pull through with Medicare Advantage. We are starting to see traction with commercial payers. That is improving all of the time.

是的。丹，我是麥克。結尾部分有點中斷，但我認為你問的是 Reveal 與 CRC 的報銷事宜。CRC 目前約占我們業務量的 50%。目前仍維持在這種水準。目前，其餘的檢查項目包括乳癌和肺癌，而我們現在獲得報銷的都是 CRC 檢測，我們為 Medicare 所做的所有檢測都能獲得報銷。這是以1640美元的匯率計算的。而且我們在聯邦醫療保險優勢計劃（M​​edicare Advantage）方面也取得了不錯的成效。我們開始看到商業保險公司對此有所反應。情況一直在改善。

And so I think we are feeling good about where the reimbursement level is. And then as we look forward, we think there is continuous runway with Reveal. Again, more and more Medicare Advantage and commercial payments on the CRC side, but as we just mentioned, we are anticipating Reveal Breast reimbursement. We have submitted the data package to MolDx for Reveal IO. And so, hopefully, going forward, we are getting incremental Medicare reimbursement and incremental reimbursement from all of the payers as we move into 2026.

所以我覺得我們對目前的報銷水準感到滿意。展望未來，我們認為 Reveal 的發展前景一片光明。再次強調，越來越多的 Medicare Advantage 和商業支付將用於 CRC，但正如我們剛才提到的，我們預計 Reveal Breast 將獲得報銷。我們已將資料包提交給 MolDx 公司，用於 Reveal IO 服務。因此，希望到 2026 年，我們能夠從所有支付方獲得逐步增加的醫療保險報銷和逐步增加的報銷。

That was our last question. That concludes today's call. Thank you for your participation and enjoy the rest of your day.

這是我們最後一個問題。今天的電話會議到此結束。感謝您的參與，祝您今天餘下的時間愉快。