使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good afternoon, and thank you for attending the Guardant Health Q2 2025 earnings conference call. My name is Jason, and I'll be the moderator today. (Operator Instructions)
下午好,感謝您參加 Guardant Health 2025 年第二季收益電話會議。我叫傑森,今天我將擔任主持人。(操作員指示)
I would now like to pass the conference over to your host, Zarak Khurshid.
現在我想將會議交給主持人 Zarak Khurshid。
Zarak Khurshid - Vice President, Investor Relations
Zarak Khurshid - Vice President, Investor Relations
Thank you. Earlier today, Guardant Health released financial results for the quarter ended June 30, 2025. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer.
謝謝。今天早些時候,Guardant Health 發布了截至 2025 年 6 月 30 日的季度財務業績。今天與我一起出席的還有 Guardant 聯合執行長 Helmy 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.
在我們開始之前,我想提醒您,在本次電話會議中,管理層將根據聯邦證券法做出前瞻性陳述。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有重大差異。本次電話會議也將討論非公認會計準則財務指標,這些指標經過調整以排除某些特定項目。
Additional information regarding material risks and uncertainties as well as the non-GAAP financial reconciliation to most directly comparable GAAP financial measures are available in the press release Guardant issued today as well as in our 10-K and other filings with the SEC. Guardant 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.
有關重大風險和不確定性以及非 GAAP 財務與最直接可比的 GAAP 財務指標的調節的更多信息,請參閱 Guardant 今天發布的新聞稿以及我們向美國證券交易委員會 (SEC) 提交的 10-K 和其他文件。除非法律要求,Guardant 不承擔更新或修改財務預測和前瞻性聲明的任何意圖或義務,無論是由於新資訊、未來事件或其他原因。
The information in this conference call is accurate only as of the live broadcast.
本次電話會議中的資訊僅在現場直播時準確。
With that, I would like to turn the live call over to Helmy.
說完這些,我想將現場通話轉交給 Helmy。
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Thanks, Zarak. Good afternoon, and thank you for joining our second-quarter 2025 earnings call. Starting on slide 3. Q2 marked another exceptional quarter for Guardant. We continue to build momentum across oncology, biopharma, and screening business lines, including accelerating therapy selection and MRD volume growth, record biopharma sales, and quickly scaling Shield volumes and revenues.
謝謝,札拉克。下午好,感謝您參加我們的 2025 年第二季財報電話會議。從投影片 3 開始。第二季度對於 Guardant 來說又是一個非凡的季度。我們繼續在腫瘤學、生物製藥和篩檢業務線上保持強勁發展勢頭,包括加速治療選擇和 MRD 量增長、創下生物製藥銷售額紀錄以及快速擴大 Shield 銷售和收入。
Product innovation built on smart liquid biopsy, combined with strong commercial execution were integral to the strong performance in the second quarter. I'll walk through some of the key highlights of the quarter in just a moment. But first, as always, I would like to start with a powerful story that demonstrates the impact our test can have on patients around the world.
基於智慧液體活檢的產品創新,加上強大的商業執行力,是第二季強勁表現的關鍵。我稍後將介紹本季的一些主要亮點。但首先,像往常一樣,我想以一個有力的故事開始,展示我們的測試對世界各地患者的影響。
Last August, a 46-year-old woman was diagnosed with Stage 3 endometrial carcinoma. Once it became clear that her cancer was progressing, her oncologists ordered a Guardant360 tissue test to help identify potential treatment options beyond the standard of care. Guardant360 Tissue had just gone through a major upgrade to incorporate comprehensive DNA and RNA and oncologists ordered both results.
去年8月,一名46歲的婦女被診斷出罹患第3期子宮內膜癌。當她的癌症明顯惡化後,腫瘤科醫生要求她進行 Guardant360 組織測試,以幫助確定超出標準治療範圍的潛在治療方案。Guardant360 Tissue 剛剛進行了重大升級,納入了全面的 DNA 和 RNA,腫瘤學家訂購了這兩項結果。
The test identified a RET fusion, an actionable biomarker that made her eligible for a targeted therapy she likely would not have received based on our initial diagnosis alone. I'm glad to be able to share that she has responded positively to this treatment and is doing well today. This case is a powerful example of how comprehensive molecular profiling through our recently upgraded Guardant360 Tissue test can help guide treatment decisions and improve patient outcomes.
測試發現了 RET 融合,這是一種可操作的生物標記物,使她有資格接受標靶治療,而僅根據我們最初的診斷,她可能不會接受這種治療。我很高興能夠告訴大家,她對這次治療反應積極,現在情況良好。這個案例有力地證明了我們最近升級的 Guardant360 組織測試如何透過全面的分子分析來幫助指導治療決策並改善患者的治療效果。
Turning to top-line performance on slide 4. Q2 revenue grew 31% year over year to $232 million, with strong performance across our oncology screening and biopharma and data businesses.
轉向幻燈片 4 上的頂線表現。第二季營收年增 31% 至 2.32 億美元,我們的腫瘤篩檢、生物製藥和數據業務表現強勁。
Starting with our oncology business on slide 5. Roughly half of the overall year-over-year revenue growth in Q2 came from the oncology business with revenue increasing 22% to $159 million. Oncology volumes increased 30% year over year to approximately 64,000 tests in the second quarter with the majority of growth driven by Guardant360 Liquid, again, closely followed by a strong contribution from Reveal.
從幻燈片 5 上的腫瘤學業務開始。第二季總營收年增約一半來自腫瘤業務,營收成長 22%,達到 1.59 億美元。第二季腫瘤學檢測量年增 30%,達到約 64,000 次,其中大部分成長由 Guardant360 Liquid 推動,緊隨其後的是 Reveal 的強勁貢獻。
Looking more closely at some of the recent highlights within our oncology business on slide 6. We saw continued volume growth across all oncology tests this quarter with particularly strong performance from Guardant360 Liquid, where year-over-year growth accelerated for the fourth-consecutive quarter and was over 20% in Q2. We continue to believe that the steady cadence of new app introductions powered by smart liquid biopsy has been instrumental to the accelerating growth profile of Guardant360 Liquid.
在第 6 張投影片上更仔細地查看我們腫瘤學業務中的一些近期亮點。本季度,我們看到所有腫瘤學檢測的數量持續增長,其中 Guardant360 Liquid 的表現尤為強勁,其同比增長連續第四個季度加速,第二季度增長超過 20%。我們仍然相信,由智慧液體活檢驅動的新應用程式的穩步推出對 Guardant360 Liquid 的加速成長起到了重要作用。
In late May, as part of the lead up to ASCO 2025, we introduced 11 groundbreaking smart liquid biopsy applications for Guardant360 Liquid, significantly expanding the clinical utility and further extending our technical leadership in the liquid CGP market. I'll walk through some of these applications in more detail shortly.
5 月下旬,作為 ASCO 2025 籌備工作的一部分,我們為 Guardant360 Liquid 推出了 11 款突破性的智慧液體活檢應用,顯著擴展了臨床實用性,並進一步擴大了我們在液體 CGP 市場的技術領導地位。我很快就會更詳細地介紹其中一些應用程式。
Guardant360 Tissue continues to be our second fastest-growing oncology product and is even better positioned today to accelerate following the major upgrade in April, which we believe make it a best-in-class product.
Guardant360 Tissue 繼續成為我們成長速度第二快的腫瘤產品,並且在 4 月進行重大升級後,如今更具備加速發展的潛力,我們相信這將成為同類最佳產品。
As a reminder, the recent improvements expand the panel to include RNA and broad methylome analysis powered by our smart liquid biopsy platform and enable readouts with 40% less slides than the industry norm, which we believe is an important differentiator.
提醒一下,最近的改進擴展了面板,包括由我們的智慧液體活檢平台支援的 RNA 和廣泛甲基化組分析,並且能夠以比行業標準少 40% 的玻片進行讀數,我們認為這是一個重要的區別。
We are also excited to report for the first time that Guardant360 tissue ASP was approximately $2,000 in Q2, achieving our 2028 target three years ahead of schedule.
我們也很高興地首次報告,Guardant360 紙巾平均售價在第二季度約為 2,000 美元,提前三年實現了我們的 2028 年目標。
For Reveal, we made great progress with data generation and publications. We recently submitted our Reveal breast cancer data package to MolDx for Medicare reimbursement and the first publication of immuno-oncology therapy monitoring data under Reveal was published this week.
對於 Reveal,我們在資料生成和發布方面取得了巨大進展。我們最近向 MolDx 提交了 Reveal 乳癌資料包以獲得醫療保險報銷,並且本週發布了 Reveal 下的第一份免疫腫瘤治療監測數據。
In May, we continue to augment our offering with the launches of Guardant hereditary cancer testing and a suite of immunohistochemistry or IHC tests. These additions bring us closer to becoming a one-stop shop for oncologists, providing insights across the patient journey.
5 月份,我們繼續擴大我們的服務範圍,推出 Guardant 遺傳性癌症檢測和一系列免疫組織化學或 IHC 檢測。這些新增功能使我們更接近成為腫瘤學家的一站式服務中心,為患者提供整個治療過程的見解。
Turning to slide 7. At the annual ASCO meeting in early June, results from the landmark SERENA-6 trial were sponsored by AstraZeneca were featured in a high-profile plenary session. This was the first pivotal trial to use a ctDNA-guided approach to detect and treat emerging resistance in first-line therapy ahead of disease progression in breast cancer.
翻到幻燈片 7。在 6 月初舉行的 ASCO 年度會議上,由阿斯特捷利康贊助的具有里程碑意義的 SERENA-6 試驗的結果在一次備受矚目的全體會議上進行了展示。這是首次使用 ctDNA 引導方法在乳癌病情進展之前檢測和治療第一線治療中出現的抗藥性的關鍵試驗。
Guardant360 was exclusive companion liquid biopsy used in the trial for this monitoring application. Feedback from KOLs during and after ASCO was incredibly positive, and we look forward to camizestrant potentially becoming a new option for breast cancer patients.
Guardant360 是本次監測應用試驗中使用的唯一伴隨液體活檢。ASCO 期間和之後 KOL 的回饋非常積極,我們期待卡米司群有可能成為乳癌患者的新選擇。
This important new paradigm involving frequent Guardant360 testing in order to quickly detect the emergence of resistance mutations has potential to change clinical practice and improve outcomes for patients with advanced breast cancer. With a prevalence pool of approximately 40,000 patients in the US, this new application of Guardant360 has the potential to drive significant incremental Guardant360 revenue in 2026 and beyond.
這個重要的新範例涉及頻繁進行 Guardant360 測試,以便快速檢測抗藥性突變的出現,有可能改變臨床實踐並改善晚期乳癌患者的預後。Guardant360 的這項新應用在美國擁有約 40,000 名患者,有可能在 2026 年及以後推動 Guardant360 收入大幅成長。
Moving on to slide 8. We have built a powerful real-world evidence platform utilizing over 100,000 genomic and broad epigenomic profiles across more than 50 cancer types. By combining the multiomic profiling capabilities of our Infinity platform with the analytical power of our Infinity AI learning engine, we are driving the development of first-of-the-kind clinical applications that are setting a new standard in precision oncology.
移至幻燈片 8。我們利用涵蓋 50 多種癌症類型的 100,000 多個基因組和廣泛的表觀基因組圖譜,建立了一個強大的真實世界證據平台。透過將我們的 Infinity 平台的多組學分析功能與我們的 Infinity AI 學習引擎的分析能力相結合,我們正在推動首創的臨床應用的開發,為精準腫瘤學樹立新的標準。
Turning to slide 9. Since July of last year, Guardant360 has delivered accelerating growth each quarter, fueled by our Guardant Infinity smart liquid biopsy platform. In Q2 alone, we launched nearly a dozen groundbreaking new apps, greatly expanding the utility of Guardant360 liquid. The latest wave of new apps include complementary genomic features, which add an even higher resolution view of tumor biology, helping healthcare providers to make smarter, more personalized treatment decisions even when tissue isn't available for analysis.
翻到第 9 張投影片。自去年 7 月以來,在 Guardant Infinity 智慧液體活檢平台的推動下,Guardant360 每個季度都實現了加速成長。僅在第二季度,我們就推出了近十幾個突破性的新應用程序,大大擴展了 Guardant360 liquid 的實用性。最新一波的新應用程式包括互補的基因組功能,這些功能增加了對腫瘤生物學更高分辨率的視圖,即使在無法進行組織分析的情況下,也能幫助醫療保健提供者做出更明智、更個性化的治療決策。
Among the many newly launched applications are cancer subtype classification using tumor-specific methylation signatures to complement and enhance standard testing methods, cancer site of origin identification when the primary site is unknown, guiding better diagnosis and therapy. Advanced negative prediction to confidently identify wild-type patients and pharmacogenomic profiling to identify genetic variations that impact the safety and efficacy of commonly used anticancer therapies.
新推出的眾多應用包括使用腫瘤特異性甲基化特徵進行癌症亞型分類,以補充和增強標準檢測方法,在原發部位未知的情況下識別癌症原發部位,以指導更好的診斷和治療。透過進階陰性預測可以自信地識別野生型患者,並透過藥物基因組學分析來識別影響常用抗癌療法的安全性和有效性的基因變異。
Now shifting gears to Reveal on slide 10, where we are the leader in tissue-free MRD. Over the last few months, we have continued to generate and publish compelling data on Reveal across a number of cancer types. As I mentioned earlier, the Reveal breast reimbursement submission has been made to MolDx and the IO monitoring study just published will support reimbursement submission for this application in the near future.
現在轉到幻燈片 10 上的展示,我們是無組織 MRD 領域的領導者。在過去的幾個月裡,我們繼續在 Reveal 上產生並發布針對多種癌症類型的令人信服的數據。正如我之前提到的,Reveal 乳癌報銷申請已經提交給 MolDx,剛剛發布的 IO 監測研究將在不久的將來支持該申請的報銷申請。
Starting with slide 11. We are excited to announce a new breast cancer publication in ESMO Open, highlighting the performance of Reveal. This retrospective study evaluated 95 patients who are diagnosed with early-stage ER-positive/HER2-negative or triple-negative breast cancer undergoing chemotherapy prior to surgery.
從投影片 11 開始。我們很高興地宣佈在 ESMO Open 上發表了一篇新的乳癌出版物,重點介紹了 Reveal 的性能。這項回顧性研究評估了 95 名被診斷為早期 ER 陽性/HER2 陰性或三陰性乳癌並在手術前接受化療的患者。
Notably, nearly 40% of patients had minimal or no residual tumor following neoadjuvant chemotherapy, demonstrating the value of Reveal's tissue-free approach. Reveal showed strong performance with 100% sensitivity for distance recurrence in patients with ER-positive/HER2-negative breast cancer, 100% specificity and 100% positive predictive value for relapse and an overall sensitivity of 71%.
值得注意的是,近 40% 的患者在新輔助化療後腫瘤殘留很少或沒有殘留,證明了 Reveal 無組織方法的價值。Reveal 表現出色,對 ER 陽性/HER2 陰性乳癌患者的遠端復發的敏感性為 100%,特異性為 100%,復發的陽性預測值為 100%,整體敏感性為 71%。
These results, combined with the data recently published in clinical cancer research, further validate Reveal's potential to transform neoadjuvant and post-treatment surveillance strategies with the ultimate goal of improving patient outcomes.
這些結果與最近在臨床癌症研究中發表的數據相結合,進一步驗證了 Reveal 改變新輔助和治療後監測策略的潛力,最終目標是改善患者的治療效果。
Moving on to slide 12. I am proud to share the RADIOHEAD/Reveal immuno-oncology monitoring study, which involved 521 Stage 4 pan-cancer patients treated with standard of care immunotherapy was published in Cancer Research Communications, a journal of the American Association of Cancer Research. This study demonstrated that any decrease in Reveal tumor fraction signal in the study was significantly associated with improved patient outcomes. Additionally, Reveal identified non-responders more than three months and as many as five months before disease progression was visible on standard imaging.
移至投影片 12。我很自豪地與大家分享 RADIOHEAD/Reveal 免疫腫瘤學監測研究,該研究涉及 521 名接受標準護理免疫療法治療的 4 期全癌症患者,並發表在美國癌症研究協會的期刊《癌症研究通訊》上。這項研究表明,研究中 Reveal 腫瘤分數訊號的任何減少都與患者預後的改善顯著相關。此外,Reveal 可以在標準成像顯示病情進展之前三個多月甚至五個月內識別出無反應患者。
Turning to slide 13. At this year's ASCO Annual Meeting, data from the largest study to date using ctDNA in Stage 3 colon cancer further validated the clinical utility of REVEAL. This Phase 3 study involved over 2,000 patients evaluated with a median follow-up of 6.1 years showed that ctDNA detected after surgery and before chemotherapy is a powerful predictor of recurrence and survival.
翻到第 13 張投影片。在今年的ASCO年會上,迄今為止使用ctDNA治療3期結腸癌的最大規模研究的數據進一步驗證了REVEAL的臨床實用性。這項 3 期研究涉及 2,000 多名患者,平均追蹤期為 6.1 年,結果顯示手術後、化療前檢測到的 ctDNA 是復發和存活的有力預測指標。
Among patients with detectable ctDNA, 63% experienced recurrence within three years compared to just 15% of those without detectable ctDNA. These findings strongly support the routine use of Guardant Reveal to stratify patients by risk, inform adjuvant therapy decisions, and ultimately improve outcomes.
在可檢測到 ctDNA 的患者中,63% 在三年內復發,而未檢測到 ctDNA 的患者中只有 15% 在三年內復發。這些發現有力地支持常規使用 Guardant Reveal 對患者進行風險分層,為輔助治療決策提供信息,並最終改善治療結果。
We have made strong progress over the last few months in MRD. Reveal volume growth accelerated in the second quarter on a year-over-year basis, consistent with our expectations, and we continue to have an extensive pipeline of clinical cohorts to further support clinical utility and analytical validity for Reveal.
過去幾個月我們在 MRD 方面取得了長足的進步。Reveal 銷售在第二季度同比增長加速,符合我們的預期,我們繼續擁有廣泛的臨床隊列,以進一步支持 Reveal 的臨床實用性和分析有效性。
Turning now to slide 14. Our oncology business is well-positioned for durable growth, supported by continued CGP penetration, favorable ASP dynamics, and international expansion. Guardant360 Liquid and Guardant360 Tissue are seeing increased adoption driven by the recently expanded genomic and epigenomic breadth of our platform, which is unlocking greater clinical utility and driving share gains.
現在翻到第 14 張投影片。在持續的 CGP 滲透、有利的 ASP 動態和國際擴張的支持下,我們的腫瘤業務已準備好實現持久成長。Guardant360 Liquid 和 Guardant360 Tissue 的採用率正在不斷提高,這得益於我們平台最近擴大的基因組和表觀基因組廣度,從而釋放出更大的臨床實用性並推動了市場份額的增長。
With a redoubled commercial focus on Reveal following major COGS improvements in Medicare CRC surveillance reimbursement earlier this year, the business is primed for strong growth in MRD.
今年早些時候,隨著醫療保險 CRC 監測報銷的 COGS 大幅改善,該公司對 Reveal 的商業關注度加倍,為 MRD 的強勁增長做好了準備。
Looking more closely at some of the recent highlights within our biopharma and data business on slide 15. We delivered a record quarter for our biopharma business, achieving all-time highs in both volume and revenue with second quarter revenue growing 28% year-over-year.
在第 15 張投影片上更仔細地查看我們生物製藥和數據業務中的一些近期亮點。我們的生物製藥業務創下了新紀錄,銷量和收入均創下歷史新高,第二季營收年增 28%。
We continue to deepen our relationship with large pharma and signed two new companion diagnostic deals in Q2. We continue to have a robust and growing pipeline of partnerships and near-term revenue visibility remains high. Of note, our biopharma volume mix continues to skew towards methylation analysis on Infinity powered by our smart liquid biopsy platform.
我們繼續深化與大型製藥公司的關係,並在第二季簽署了兩項新的伴隨診斷協議。我們繼續擁有強勁且不斷增長的合作夥伴關係,近期收入可見度仍然很高。值得注意的是,我們的生物製藥產量組合繼續偏向由我們的智慧液體活檢平台支援的 Infinity 上的甲基化分析。
With that, I will now turn the call over to AmirAli for an update on screening.
說完這些,我現在將電話轉給 AmirAli,詢問其篩選的最新情況。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Thanks, Helmy. Moving on to slide 16. We delivered $15 million of Shield testing revenue in Q2, driven by approximately 16,000 tests. We are pleased to see continued strong traction for Shield in the third full quarter of commercial launch.
謝謝,Helmy。翻到第 16 張投影片。我們在第二季度實現了 1500 萬美元的 Shield 測試收入,其中約有 16,000 次測試。我們很高興看到 Shield 在商業發布的第三季度繼續保持強勁成長勢頭。
Shield continues to generate strong enthusiasm from both patients and physicians with high adherence rates that continue to be over 90%, meaning we received blood samples 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 standard PCP care. We also continue to observe strong depth of ordering per physician.
Shield 繼續受到患者和醫生的強烈歡迎,其高依從率持續超過 90%,這意味著我們收到了超過 90% 的訂購病例的血液樣本。這表明 Shield 作為 CRC 篩檢的常規血液檢查非常簡單,可以納入標準 PCP 護理中。我們也繼續觀察到每位醫生的訂購深度很強。
Moreover, we've been encouraged with the momentum in sales rep productivity in the field, although it's still early days in our commercial journey and the average tenure of our sales reps is less than eight months.
此外,儘管我們的商業旅程仍處於早期階段,並且我們的銷售代表的平均任期不到八個月,但我們對該領域銷售代表生產力的勢頭感到鼓舞。
Given our performance this quarter across revenue, volume, and gross margin, we are further accelerating the build-out of our commercial infrastructure and now expect to surpass 250 sales reps by year-end to support this growth as we go to 2026.
鑑於本季在收入、銷售和毛利率方面的表現,我們正在進一步加快商業基礎設施的建設,目前預計到年底銷售代表人數將超過 250 人,以支持 2026 年的成長。
Moving on to slide 17. In late May, we are very encouraged to see National Comprehensive Cancer Network, or NCCN, updated its CRC screening guidelines to include Shield. The new NCCN guidelines place Shield in Category 2A, which is the same category recommendation as the other first-line screening modalities. This represents the first national guideline recommendation for Shield, and in our view, paves the way for improved commercial coverage and patient access. This also supports our confidence that Shield will be included in other national CRC screening guidelines in the future.
移至投影片 17。5 月下旬,我們很高興看到美國國家綜合癌症網絡 (NCCN) 更新了其 CRC 篩檢指南,將 Shield 納入其中。新的 NCCN 指南將 Shield 置於 2A 類,這與其他第一線篩檢方式的類別建議相同。這是針對 Shield 的首個國家指南建議,我們認為,這為改善商業覆蓋範圍和患者可近性鋪平了道路。這也增強了我們的信心,Shield 未來將納入其他國家 CRC 篩檢指南。
Now turning to slide 18 to take a closer look at screening highlights for the second quarter 2025. Starting with Shield CRC. As I mentioned earlier, we are very pleased with the high patient adherence, strong depth of ordering per physician, and the productivity of our reps in the field. We are also very excited to see Shield is now a guideline recommended screening test by the NCCN.
現在翻到第 18 張幻燈片來仔細看看 2025 年第二季的放映亮點。從 Shield CRC 開始。正如我之前提到的,我們對患者的高依從性、每位醫生的強大醫囑深度以及我們在該領域的代表的生產力感到非常滿意。我們也很高興看到 Shield 現在是 NCCN 推薦的篩檢測試指南。
Along with this strong momentum, Shield was recently named a winner of Fast Company's 2025 World Changing Idea Awards, an award that recognizes innovative companies and projects addressing the world's most urgent challenges.
除了這一強勁勢頭之外,Shield 最近還被《Fast Company》雜誌評為「2025 年改變世界創意獎」的獲得者,該獎項旨在表彰解決全球最緊迫挑戰的創新公司和項目。
Beyond CRC, we made meaningful progress with Shield multi-cancer detection and CD in the second quarter. As a reminder, we presented the clinical validation of Shield MCD test at AACR and ASCO this year. This momentum continued when Shield MCD received breakthrough device designation from the FDA, making an important milestone for us.
除了 CRC 之外,我們在第二季度在 Shield 多癌症檢測和 CD 方面也取得了有意義的進展。提醒一下,我們今年在 AACR 和 ASCO 上展示了 Shield MCD 測試的臨床驗證。當 Shield MCD 獲得 FDA 的突破性設備稱號時,這種勢頭得以延續,這對我們來說是一個重要的里程碑。
Moving on to slide 21 (sic - slide 19). As a reminder, our goal has always been to detect cancer early when it's most treatable. We developed our Shield assay as a platform capable of multi-cancer detection with CRC screening representing just the first indication for Shield given it has an established regulatory and reimbursement pathway. While we are encouraged by the strong traction we are seeing for Shield CRC, we are even more excited about broadening the impact of Shield across multiple cancer types.
前往投影片 21(原文如此 - 投影片 19)。提醒一下,我們的目標一直是及早發現癌症,以便最容易治療。我們開發了 Shield 檢測平台,能夠進行多種癌症檢測,其中 CRC 篩檢只是 Shield 的第一個適應症,因為它具有成熟的監管和報銷途徑。雖然我們對 Shield CRC 的強勁發展勢頭感到鼓舞,但我們更興奮的是擴大 Shield 對多種癌症類型的影響。
Moving on to slide 22 (sic - slide 20). In early January, we announced Shield selection for inclusion in the National Cancer Institute's Vanguard study, which is a 24,000-patient pilot study to evaluate the use of MCD tests. As a reminder, Shield was one of only two technologies selected through a highly competitive process.
移至投影片 22(原文如此 - 投影片 20)。1 月初,我們宣布 Shield 入選美國國家癌症研究所的 Vanguard 研究,這是一項涉及 24,000 名患者的試驗研究,旨在評估 MCD 測試的使用情況。提醒一下,Shield 是透過激烈的競爭過程選出的僅有的兩種技術之一。
We are pleased to share the commencement of NCI Vanguard study just a few weeks ago, and we have already started delivering MCD results to physicians and their patients through this trial. The initiation of this study establishes the clinical and operational readiness for Shield MCD and marks an important milestone for the Shield platform. We are looking forward to broadening access to Shield MCD beyond the scope of the Vanguard study in the near future.
我們很高興地宣布,幾週前 NCI Vanguard 研究已經開始,並且我們已經開始透過這項試驗向醫生及其患者提供 MCD 結果。這項研究的啟動為 Shield MCD 的臨床和操作做好了準備,標誌著 Shield 平台的一個重要里程碑。我們期待在不久的將來將 Shield MCD 的存取權限擴展到 Vanguard 研究的範圍之外。
Looking ahead, Shield V2 continues to be a very active program for us, and we remain confident about the potential inclusion of Shield in American Cancer Society or ACS guidelines.
展望未來,Shield V2 對我們來說仍然是一個非常活躍的項目,我們對 Shield 被納入美國癌症協會或 ACS 指南的可能性充滿信心。
With that, I will now turn the call over to Mike for more detail on our financials.
說完這些,我現在將把電話轉給麥克,以了解有關我們財務狀況的更多詳細資訊。
Michael Bell - Chief Financial Officer
Michael Bell - Chief Financial Officer
Thanks, AmirAli. Turning to slide 23 (sic - slide 21). I'll now discuss some select financial highlights for the quarter ended June 30, 2025. I'll refer to year-over-year growth rates unless otherwise noted. Second-quarter total revenue grew 31% to $232.1 million, driven by strong performance across all our key revenue lines, oncology, biopharma, and data and screening.
謝謝,AmirAli。翻到第 23 張投影片(原文如此 - 第 21 張投影片)。我現在將討論截至 2025 年 6 月 30 日的季度的一些財務亮點。除非另有說明,我將參考同比增長率。第二季總營收成長 31% 至 2.321 億美元,這得益於我們所有主要收入線、腫瘤學、生物製藥以及數據和篩檢的強勁表現。
Starting with our oncology business. Oncology revenue grew 22% to $158.7 million, primarily driven by another quarter of accelerated volume growth. As a reminder, oncology volume consists of our Guardant360 liquid and tissue therapy selection tests and our Reveal and Response monitoring tests. Oncology volume grew 30% to approximately 64,000 tests in Q2, with the majority of growth driven by Guardant360 Liquid, closely followed by a strong contribution from Reveal.
從我們的腫瘤學業務開始。腫瘤學收入成長 22% 至 1.587 億美元,主要得益於另一個季度的銷售加速成長。提醒一下,腫瘤學卷包括我們的 Guardant360 液體和組織治療選擇測試以及我們的揭露和反應監測測試。第二季腫瘤學檢測量成長了 30%,達到約 64,000 次,其中大部分成長由 Guardant360 Liquid 推動,緊隨其後的是 Reveal 的強勁貢獻。
Guardant360 Liquid year-over-year volume growth accelerated for the fourth consecutive quarter and was over 20% in Q2. Reveal year-over-year volume growth also accelerated in Q2 and continues to be our fastest-growing oncology product.
Guardant360 Liquid 交易量較去年同期成長連續第四個季度加速,第二季增幅超過 20%。Reveal 的銷售年增率在第二季也有所加速,並且持續成為我們成長最快的腫瘤產品。
We also continue to see strong oncology ASPs in Q2. Guardant360 Liquid ASP was in the range of $3,000 to $3,100 in the second quarter of 2025, in line with the prior quarter.
我們也看到第二季腫瘤學平均售價持續保持強勁。2025 年第二季度,Guardant360 Liquid ASP 在 3,000 美元至 3,100 美元之間,與上一季持平。
Guardant360 Tissue ASP increased to approximately $2,000 in Q2, which means that we have reached our 2028 tissue ASP target three years ahead of schedule. This has been driven by the increase in Medicare pricing from $3,140 to $3,500 at the start of the year, good progress with commercial payers and incremental reimbursement related to the recently launched tissue RNA feature.
Guardant360 紙巾平均售價在第二季度上漲至約 2,000 美元,這意味著我們提前三年實現了 2028 年紙巾平均售價目標。這是由於今年年初醫療保險價格從 3,140 美元上漲至 3,500 美元、商業付款人取得良好進展以及與最近推出的組織 RNA 功能相關的增量報銷。
We've been very encouraged by the attachment of RNA to our Guardant360 tissue test, and we want to highlight that we do not count tissue RNA separately from Guardant360 tissue in our reported volumes.
我們對 RNA 添加到我們的 Guardant360 組織測試中感到非常鼓舞,我們想強調的是,在報告的數量中,我們不會將組織 RNA 與 Guardant360 組織分開計算。
Reveal ASP continues to be in the range of $600 to $700 following Medicare CRC surveillance coverage earlier in the year. AS of period revenue was consistent with normal expected levels in Q2 and did not provide a material upside in the quarter.
根據今年稍早的 Medicare CRC 監測報告顯示,ASP 繼續保持在 600 美元至 700 美元的範圍內。期間營收的 AS 與第二季的正常預期水準一致,並且在本季沒有帶來實質的成長。
Finally, note that we do not include Guardant Hereditary cancer testing or IHC volumes in our reported volumes, and we expect minimal revenue contribution from these new offerings throughout 2025.
最後,請注意,我們的報告數量不包括 Guardant 遺傳性癌症檢測或 IHC 數量,並且我們預計這些新產品在 2025 年全年的收入貢獻很小。
Our biopharma and data business performed incredibly well again in the second quarter with record revenue totaling $56 million, an increase of 28%. Our biopharma pipeline continues to shape up solidly, driven by Guardant Infinity and additional companion diagnostic partnerships signed in the quarter, all of which add to our confidence in both the short-term and long-term business.
我們的生物製藥和數據業務在第二季度再次表現優異,總收入創紀錄地達到 5,600 萬美元,成長 28%。在 Guardant Infinity 和本季度簽署的其他伴隨診斷合作夥伴關係的推動下,我們的生物製藥產品線繼續穩步發展,所有這些都增強了我們對短期和長期業務的信心。
Finally, we continue to see increasing revenue contribution from Shield, with screening revenue totaling $14.8 million in Q2 generated from the 16,000 Shield tests that we reported in the quarter.
最後,我們繼續看到 Shield 的營收貢獻不斷增加,第二季我們報告的 16,000 次 Shield 測試產生了總計 1,480 萬美元的篩檢收入。
Turning to slide 24 (sic - slide 22). We're extremely pleased to report that we are making great progress with Shield non-GAAP gross margin, which increased to 48% in Q2 compared to 18% in Q1 2025 and 2% in Q4 2024. This was driven by continued improvements in both ASP and COGS.
翻到第 24 張投影片(原文如此 - 第 22 張投影片)。我們非常高興地報告,Shield 非 GAAP 毛利率取得了巨大進步,第二季毛利率上升至 48%,而 2025 年第一季為 18%,2024 年第四季為 2%。這是由 ASP 和 COGS 的持續改善所推動的。
Shield ASP was over $900 in Q2, which represents a significant increase over the ASP of approximately $600 in Q1. The main drivers of ASP improvement were the increase to our Medicare rate from $920 to $1,495 following the receipt of ADLT status, which became effective on April 1 and the continued high mix of reimbursable test volume.
Shield 的平均售價在第二季超過 900 美元,與第一季約 600 美元的平均售價相比有大幅成長。ASP 改善的主要驅動力是,在獲得 ADLT 狀態(於 4 月 1 日生效)後,我們的醫療保險費率從 920 美元增加到 1,495 美元,並且可報銷測試量持續保持在較高水準。
It should also be noted that the Shield ASP reflects the strong reimbursement that we are receiving from Medicare Advantage payers. Equally pleasing is that Shield non-GAAP cost per test further reduced in Q2 and is now less than $500. This continued improvement is driven by increased Shield volume and the excellent performance of our operations team in maintaining rigorous cost controls and driving efficiency gains.
還應該注意的是,Shield ASP 反映了我們從 Medicare Advantage 付款人那裡獲得的豐厚報銷。同樣令人高興的是,Shield 非 GAAP 每次測試成本在第二季進一步降低,目前不到 500 美元。這種持續的改進得益於盾構產量的增加以及我們的營運團隊在維持嚴格的成本控制和提高效率方面的出色表現。
Similar to last quarter, we plan to reinvest the incremental Shield gross profit we generate back into the sales and marketing line to accelerate the screening commercial infrastructure build-out. We continue to be very proud of the financial profile that Shield has demonstrated in such a short period of time.
與上一季類似,我們計劃將產生的增量 Shield 毛利重新投資到銷售和行銷線上,以加速篩選商業基礎設施的建設。我們繼續對 Shield 在如此短的時間內展現出的財務狀況感到非常自豪。
Turning to slide 25 (sic - slide 23). Our non-GAAP gross profit was $153.8 million, an increase of $47 million or 44% year over year. Our non-GAAP gross margin of 66% was above our expectations in the second quarter of 2025 and was a significant improvement compared to 60% in the second quarter of '24.
翻到第 25 張投影片(原文如此 - 第 23 張投影片)。我們的非公認會計準則毛利為 1.538 億美元,年增 4,700 萬美元,增幅為 44%。2025 年第二季度,我們的非 GAAP 毛利率為 66%,高於我們的預期,與 2024 年第二季的 60% 相比有顯著改善。
The improvement in gross margin is primarily a result of improved oncology ASPs as well as a significant turnaround in gross margins for Reveal and Shield, which were both gross margin negative in Q2 2024 and which are now both gross margin positive. As we noted last quarter, Reveal cost per test has reduced from over $1,000 in 2024 to less than $500 in 2025.
毛利率的提高主要得益於腫瘤學平均售價的提高,以及 Reveal 和 Shield 毛利率的大幅好轉,這兩個品牌在 2024 年第二季度的毛利率均為負值,而現在均變為正值。正如我們上個季度所指出的,Reveal 每次測試的成本已從 2024 年的 1,000 多美元降至 2025 年的不到 500 美元。
Non-GAAP operating expenses were $215.3 million in the second quarter of 2025, an increase of 20% and in line with our expectations. Both non-GAAP R&D and G&A expenses in the quarter were approximately flat compared to prior year, which reflects the operating leverage that we're achieving throughout the business.
2025 年第二季非公認會計準則營運費用為 2.153 億美元,成長 20%,符合我們的預期。本季的非公認會計準則研發費用和一般及行政費用與去年同期相比基本持平,這反映了我們在整個業務中實現的營運槓桿。
Non-GAAP sales and marketing expense increased 45% to $107.8 million in the second quarter of 2025. This increase was due to the ongoing screening commercial build-out as well as continued investment in oncology, sales and marketing.
2025 年第二季非公認會計準則銷售和行銷費用成長 45% 至 1.078 億美元。這一增長歸因於正在進行的篩檢商業建設以及對腫瘤學、銷售和行銷的持續投資。
Adjusted EBITDA loss was $51.9 million for Q2 2025, an improvement of $10 million compared to a loss of $61.9 million in Q2 2024. We continue to be focused on cash management and reducing our burn in 2025 versus 2024.
2025 年第二季調整後 EBITDA 虧損為 5,190 萬美元,較 2024 年第二季 6,190 萬美元的虧損改善了 1,000 萬美元。我們將繼續專注於現金管理,並減少 2025 年和 2024 年的現金消耗。
Q2 2025 free cash flow burn was $65.9 million compared to $99.1 million in the prior year period. We ended the quarter with approximately $735 million in cash, cash equivalents and restricted cash.
2025 年第二季自由現金流消耗為 6,590 萬美元,去年同期為 9,910 萬美元。本季末,我們擁有約 7.35 億美元的現金、現金等價物和受限現金。
Moving to slide 26 (sic - slide 24) for our outlook and assumptions for the full year 2025. We're increasing our full year 2025 revenue guidance for the second time this year to be in the range of $915 million to $925 million, representing growth of approximately 24% to 25% compared to 2024 and an increase of $35 million compared to our prior range of $880 million to $890 million.
前往投影片 26(原文如此 - 投影片 24),查看我們對 2025 年全年的展望和假設。我們今年第二次調高 2025 年全年營收預期,將其定為 9.15 億美元至 9.25 億美元,較 2024 年成長約 24% 至 25%,較先前的 8.8 億美元至 8.9 億美元增加 3,500 萬美元。
We now expect oncology revenue to grow approximately 20% year over year in 2025 compared to our prior guidance of 18%. The increase is based on stronger-than-expected Guardant360 Liquid and Reveal volumes in Q2 2025 as well as higher oncology volume now projected for the remainder of the year.
我們現在預計,到 2025 年,腫瘤學收入將年增約 20%,而我們先前的預測是 18%。此次成長是基於 2025 年第二季 Guardant360 Liquid 和 Reveal 銷量強於預期,以及預計今年剩餘時間腫瘤學銷量將增加。
For the full year 2025, we now expect total oncology volume to grow greater than 27% versus our prior expectation of greater than 25%. We continue to expect our biopharma and data business to perform well throughout 2025 and now expect mid-teens revenue growth compared to our prior expectation of low double-digit growth.
對於 2025 年全年而言,我們目前預計腫瘤治療總量將增加 27% 以上,而我們先前預期的成長幅度為 25% 以上。我們繼續預期我們的生物製藥和數據業務將在 2025 年表現良好,目前預計收入成長率將達到十五六個百分點,而我們先前預期的成長率為兩位數。
We're also raising our full-year 2025 Shield revenue guidance again this quarter to $55 million to $60 million from our prior guidance of $40 million to $45 million. This increase is largely driven by higher volume where we now expect 68,000 to 73,000 tests versus our prior guidance of 52,000 to 58,000 tests.
本季度,我們也將 2025 年全年 Shield 營收預期從先前的 4,000 萬至 4,500 萬美元上調至 5,500 萬至 6,000 萬美元。這一增長主要是由於檢測量增加所致,我們目前預計檢測量將達到 68,000 至 73,000 次,而我們先前預測的檢測量為 52,000 至 58,000 次。
Our Shield revenue guidance assumes an ASP of approximately $800 for the second half of 2025, slightly lower than our Q2 ASP as we anticipate potential changes to the mix of Medicare and commercial pay tests as we scale the business. With the significant improvements to gross margins that we've generated during the first half of the year, we are raising our full-year non-GAAP gross margin guidance to be in the range of 63% to 64% compared to the previous range of 62% to 63%.
我們的 Shield 收入指引假設 2025 年下半年的 ASP 約為 800 美元,略低於我們的第二季 ASP,因為我們預計隨著業務規模的擴大,醫療保險和商業支付測試的組合可能會發生變化。由於我們上半年毛利率顯著提高,我們將全年非 GAAP 毛利率預期從先前的 62% 至 63% 上調至 63% 至 64%。
As we've previously outlined, we plan to reinvest any incremental screening gross profit we generate throughout the year back into the business to accelerate our commercial infrastructure build-out. As a result of improved Shield volume and gross margin, we're increasing our sales and marketing efforts and now expect 2025 non-GAAP operating expenses to be in the range of $840 million to $850 million, representing an 11% to 12% increase compared to 2024. We continue to expect full-year non-GAAP R&D and G&A expenses to be relatively flat compared to 2024.
正如我們之前所概述的,我們計劃將全年產生的所有增量篩選毛利重新投資到業務中,以加速我們的商業基礎設施建設。由於 Shield 銷售量和毛利率的提高,我們正在加大銷售和行銷力度,目前預計 2025 年非 GAAP 營運費用將在 8.4 億美元至 8.5 億美元之間,與 2024 年相比增長 11% 至 12%。我們仍然預計全年非 GAAP 研發和 G&A 費用與 2024 年相比將相對持平。
Lastly, our commitment to cash burn reduction each year in order to reach company-wide cash flow breakeven in 2028 is unchanged. For full year 2025, we still expect free cash flow burn to be in the range of $225 million to $235 million, an improvement compared to $275 million for 2024. We continue to expect our cash burn in 2025 to consist of approximately $200 million related to screening as we scale our Shield business and maximize our first-mover advantage.
最後,我們每年減少現金消耗以在 2028 年實現全公司現金流量收支平衡的承諾保持不變。對於 2025 年全年,我們仍預期自由現金流消耗將在 2.25 億美元至 2.35 億美元之間,與 2024 年的 2.75 億美元相比有所改善。隨著我們擴大 Shield 業務規模並最大限度地發揮先發優勢,我們預計 2025 年與篩檢相關的現金消耗將達到約 2 億美元。
Significantly, excluding screening, we continue to expect the remainder of the business to burn approximately $25 million to $35 million during the year and to reach free cash flow breakeven in the fourth quarter of 2025.
值得注意的是,除篩選外,我們繼續預期其餘業務將在今年消耗約 2,500 萬至 3,500 萬美元,並在 2025 年第四季實現自由現金流盈虧平衡。
Moving on to slide 27 (sic - slide 25). At the start of the year, we outlined an ambitious pipeline of catalysts, and it's a testament to our team's strong execution that we've delivered on nearly all of them just halfway through the year.
移至投影片 27(原文如此 - 投影片 25)。在今年年初,我們制定了一系列雄心勃勃的催化劑計劃,僅在今年年中我們就幾乎實現了所有計劃,這證明了我們團隊強大的執行力。
And finally, turning to slide 28 (sic - slide 26). We'll be hosting an Investor Day on Wednesday, September 24, in New York City. We look forward to sharing a deeper dive across our business. Please reach out to investors@guardanthealth.com for more information.
最後,翻到第 28 張投影片(原文如此 - 第 26 張投影片)。我們將於 9 月 24 日星期三在紐約市舉辦投資者日。我們期待更深入地分享我們的業務。請聯絡 investors@guardanthealth.com 以獲取更多資訊。
With that, we'll now open the call to questions.
現在,我們開始回答問題。
Operator
Operator
(Operator Instructions) Mark Massaro, BTIG.
(操作員指示)Mark Massaro,BTIG。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Congratulations on the strong beat and raise. Helmy, the first one is for you. Clearly, you guys are doing a really great job in G360 Liquid and you've raised the volume guidance for the year. You talked about SERENA-6. And what I'm curious about is, did you see any benefit from the New England Journal publication perhaps in Q2? And can you give us a sense for the likelihood that you can continue to drive the interval of testing in 360 in breast cancer?
恭喜強勢擊敗並加註。Helmy,第一個是給你的。顯然,你們在 G360 Liquid 方面做得非常出色,並且提高了今年的銷售預期。您談到了 SERENA-6。我很好奇的是,您是否認為《新英格蘭雜誌》的出版在第二季帶來了任何好處?您能否告訴我們,您繼續推動乳癌 360 度檢測間隔的可能性有多大?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yeah. No, thanks for the question. We're happy with the quarter, obviously, and happy with the performance of our core business. I think as we've said, this quarter, we saw something like over 20% growth for G360, which is just fantastic to see this kind of growth, a product that's been in the market for so long.
是的。不,謝謝你的提問。顯然,我們對本季的表現感到滿意,也對我們的核心業務的表現感到滿意。我想,正如我們所說的,本季度,我們看到 G360 的成長超過 20%,對於一款已經在市場上銷售了很長時間的產品來說,看到這樣的成長真是太棒了。
And I think what we're seeing right now is really, I think, a testament to the product market fit we've achieved with our Infinity smart liquid biopsy platform. And I think there's a lot more juice to squeeze.
我認為我們現在所看到的確實證明了我們的 Infinity 智慧液體活檢平台已經實現了產品市場契合。我認為還有更多的潛力可以挖掘。
If there was SERENA-6 impact, it was very minimal. This quarter, we think we'd see the majority of that once and if the drug is finally approved. And we obviously are very excited about that in terms of the potential for adding significantly more testing opportunities to the liquid biopsy space.
如果有 SERENA-6 的影響,其影響也是非常小的。本季度,我們認為,如果該藥物最終獲得批准,我們將看到大部分結果。我們對此感到非常興奮,因為這有可能為液體活檢領域增加更多的檢測機會。
But I think this is really, I think, shows kind of how big the CGP liquid biopsy market is. I think we're still in the early innings of converting users to essentially just one test to the first test from a liquid biopsy space. But we have so much room to run, I think, so many years of growth ahead of us as we start getting this sort of monitoring paradigm really kind of fully realized by the market.
但我認為這確實表明了 CGP 液體活檢市場有多大。我認為我們仍處於將使用者從液體活檢領域轉化為第一個測試的早期階段。但我認為,隨著這種監控模式開始真正被市場充分認識到,我們還有很大的發展空間,未來還有很多年的成長空間。
Operator
Operator
Puneet Souda, Leerink.
Puneet Souda,Leerink。
Puneet Souda - Analyst
Puneet Souda - Analyst
Hey, guys. Thanks for the questions here, and congrats on a really strong quarter. If you don't mind, I'll try to squeeze my questions into one. First, Shield growth is obviously very impressive. Can you talk a little bit about what's driving that among PCPs among the PCP practices? Is it NCCN? Is it the ramp in the sales force? And wondering if you can give sort of an ASP number, it seems to be higher than the 800 that you had projected. So wondering where that's going to land.
嘿,大家好。感謝您的提問,並祝賀本季業績表現強勁。如果您不介意的話,我會盡量把我的問題濃縮成一個。首先,Shield 的成長顯然非常令人印象深刻。您能否稍微談談 PCP 在 PCP 實務中採取此做法的推動因素?是NCCN嗎?是銷售隊伍的壯大嗎?我想知道您是否可以提供一個 ASP 數字,它似乎高於您預期的 800。所以想知道它會落到哪裡。
And around Shield, if I may also ask, Shield V2 is a big focus for investors. We were hoping for data by now. Any updates on that data?
關於 Shield,如果我可以問的話,Shield V2 是投資人關注的重點。我們現在希望獲得數據。有關於該數據的更新嗎?
And I'll pause there. I have more questions, but I'll follow up with Helmy later.
我就此暫停一下。我還有其他問題,但稍後我會與 Helmy 進行跟進。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Okay. Thanks, Puneet, for good question. So we are very excited with the Shield commercial performance. We are continuing to see a very strong pull by market. When physicians are becoming aware of this test and they're getting access to this test as we are scaling up our footprint in the field in terms of reps, we are seeing a very strong demand.
好的。謝謝 Puneet,這個問題問得好。因此我們對 Shield 的商業表現感到非常興奮。我們繼續看到市場強勁的拉動。當醫生們開始意識到這項測試,並且隨著我們在該領域的代表人數不斷擴大而獲得這項測試的機會時,我們看到了非常強勁的需求。
And I think this beat and raise is really an endorsement of a higher productivity that we are seeing in this newly formed sales team that we have kind of assembled. And we are very excited about it and looking forward to see what we can do in second half of the year.
我認為,這種超出預期的業績成長確實證明了我們新組建的銷售團隊的生產力有所提高。我們對此感到非常興奮,並期待看到下半年我們能取得什麼成就。
Maybe I go to Shield V2 and then I give it to Mike to talk about ASP. As I mentioned in the prepared remarks, V2 is a very active program for us. A lot of work has gone into it and still it's ongoing, and we'll see what happens. Mike?
也許我會去找 Shield V2 然後把它交給 Mike 來談論 ASP。正如我在準備好的演講中提到的,V2 對我們來說是一個非常活躍的計劃。我們已為此投入了大量工作,並且仍在繼續進行中,我們將拭目以待。麥克風?
Michael Bell - Chief Financial Officer
Michael Bell - Chief Financial Officer
Yeah. I can add on the ASP that we saw a really good uplift in Shield ASP in the quarter. We went from in Q1, ASP was just over $600. And in Q2, that increased to over $900. And the main driver of that obviously was that the ADLT status became effective on the 1st of April.
是的。我可以補充一下 ASP,我們在本季看到 Shield ASP 有了非常好的提升。從第一季開始,平均售價就剛剛超過 600 美元。而在第二季度,這一數字增加到 900 美元以上。而其主要驅動因素顯然是 ADLT 狀態於 4 月 1 日生效。
So our Medicare rate increased from $920 to $1,495. And we're also seeing very strong Medicare Advantage reimbursement that's coming through now from pretty much all of the payers. And so that's helping to really stabilize that ASP.
因此我們的醫療保險費率從 920 美元增加到 1,495 美元。我們也看到,幾乎所有付款人都提供了非常強勁的醫療保險優勢報銷。這有助於真正穩定 ASP。
I think when we look at the back half of the year, and we said it in the prepared remarks, we'd expect our ASP for the next six months to be around $800. And so that will be slightly lower than Q2. And really, that's a function of the mix. As we continue to scale, we think we'll see more of the mix move from Medicare, Medicare Advantage on to commercial. So we're just allowing for that over the next six months. But yeah, I think ASP story on Shield has been really positive for us this quarter.
我認為,當我們展望下半年時,正如我們在準備好的評論中所說,我們預計未來六個月的平均銷售價格將在 800 美元左右。因此這將略低於第二季。事實上,這是混合的功能。隨著我們不斷擴大規模,我們認為我們會看到更多的組合從醫療保險、醫療保險優勢轉向商業。所以我們只是在接下來的六個月內考慮這一點。但是的,我認為 Shield 的 ASP 故事本季對我們來說確實很積極。
Operator
Operator
Dan Brennan, TD Cowen.
丹布倫南 (Dan Brennan),TD Cowen。
Daniel Brennan - Analyst
Daniel Brennan - Analyst
Thank you. Thanks for the question. Maybe just one on G360 since doing so well and it's your biggest business. Just could you give a little color in terms of kind of where the growth is coming from? Do you feel that you're seeing better penetration maybe locally or big AMCs? Do you feel like it's more just penetration in the existing market, or do you feel like maybe you're taking share?
謝謝。謝謝你的提問。也許 G360 上只有一個,因為它做得很好,而且它是你最大的業務。您能否稍微解釋一下這種成長源自於哪裡?您是否覺得本地或大型 AMC 的滲透率更高了?您是否覺得這只是在現有市場的滲透,還是您可能正在搶佔市場份額?
And then the other factor is Helmy, you discussed a lot of the benefits of smart liquid biopsy in terms of the performance. Is that resonating at the oncologist level? Is that really a sale into the hospital administrator? Just trying to unpack a little bit your growth versus maybe the other players in the broader market.
然後另一個因素是 Helmy,您討論了智慧液體活檢在性能方面的許多好處。這在腫瘤學家層面上引起共鳴嗎?這真的是對醫院管理者的推銷嗎?只是想稍微分析一下你的成長與更廣闊市場中的其他參與者相比有何不同。
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yeah. No, that's a great question. When we dissect the numbers, it really is a broad-based growth. We're seeing more oncologists than ever before ordering every single month. So that continues to grow pretty dramatically over the last few quarters since we launched smart liquid biopsy.
是的。不,這是一個很好的問題。當我們分析這些數字時,我們發現這確實是一個廣泛的成長。我們每個月會診的腫瘤科醫師比以往任何時候都多。自從我們推出智慧液體活檢以來,過去幾個季度裡,這一數字持續大幅成長。
We're seeing higher depth. So in those same accounts, we're seeing a much higher average of number of 360 tests per month. And so that's really exciting. So we know that is coming from just the increased utilization of the test, we're growing the sort of market and use cases of liquid biopsy, but also significant share gains as well, which is great to see.
我們看到了更高的深度。因此,在相同的帳戶中,我們看到每月 360 次測試的平均數量要高得多。這真的非常令人興奮。因此,我們知道這僅僅是由於測試利用率的提高,我們正在擴大液體活檢的市場和用例,同時也顯著增加了份額,這是令人高興的。
And I think as I alluded to before, we have a test that truly has achieved much greater product market fit than anything out there. And when we talk about these features, these features are really resonating at the oncologist level. I was at ASCO. I can tell you that many of the key opinion leaders we work with, many academic center oncologists are really, really excited about these features. But these features resonate at the community level as well.
我認為,正如我之前提到的,我們有一個測試,它確實比現有的任何測試都更能實現產品市場契合度。當我們談論這些特徵時,這些特徵確實在腫瘤學家層面引起了共鳴。我當時在 ASCO。我可以告訴你,我們合作的許多關鍵意見領袖、許多學術中心腫瘤學家都對這些功能感到非常非常興奮。但這些特質在社區層面也引起了共鳴。
The fact that we can do what sometimes tissue can't, the fact that we can see how the tumor is evolving from a subtype point of view, which has serious implications in terms of treatment decisions. We can see those patients who may be -- may qualify for certain drugs that many other tests out there can from immunotherapies to PARP inhibitors.
事實上,我們可以做到組織有時無法做到的事情,我們可以從亞型的角度了解腫瘤是如何演變的,這對治療決策具有重要意義。我們可以看到那些可能適合接受某些藥物治療的患者,而許多其他測試也表明這些藥物可以用於從免疫療法到 PARP 抑制劑的治療。
And this is just the beginning in terms of what we're able to do. I can tell you that the pipeline we have of new applications and new apps that we're going to launch over the coming quarters is probably even more exciting than what we've launched today.
就我們能做的事情而言,這只是一個開始。我可以告訴你們,我們在未來幾季即將推出的新應用程式和新應用程式可能比我們今天推出的更令人興奮。
So there's many things, I think as I told you we could do three years ago, most oncologists, most scientists would have said is science fiction. And that is really, I think, the power of this platform in terms of what we can do. And it's -- and you're starting to see it in the numbers on both the biopharma side and now the clinical side.
所以有很多事情,我想正如我三年前告訴你的那樣,我們可以做很多事情,大多數腫瘤學家、大多數科學家會說這是科幻小說。我認為,就我們能做的事情而言,這確實就是這個平台的威力。而且 — — 你開始在生物製藥方面和現在的臨床方面的數字中看到這一點。
Operator
Operator
Tycho Peterson, Jefferies.
傑富瑞 (Jefferies) 的 Tycho Peterson。
Tycho Peterson - Analyst
Tycho Peterson - Analyst
Hye, thanks. On Shield, congrats on the Vanguard enrollment. I'm just wondering if you can walk through kind of next steps to getting Shield marketed as an MCD test. Do you have to wait for data from the ongoing lung study or an interim Vanguard readout? How do you feel about inducement concerns? That seems to be a bit of a debate in the investment community.
嘿,謝謝。在 Shield 上,恭喜您加入先鋒隊。我只是想知道您是否可以介紹一下將 Shield 作為 MCD 測試推向市場的後續步驟。您是否必須等待正在進行的肺部研究的數據或中期先鋒讀數?您對誘導擔憂有何看法?這似乎在投資界引起了一些爭論。
And then can you maybe just talk to your view on the risk around USPSTF? Obviously, if the whole panel gets replaced, that could throw a monkey wrench.
那麼,您能否談談您對 USPSTF 風險的看法?顯然,如果更換整個面板,可能會造成麻煩。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Yeah. So Tycho, we are very excited with this progress we had on the R&D side. Now MCD is clinically validated. So it's clinically validated. We are not waiting for any other test or test to be a clinical-grade test.
是的。所以 Tycho,我們對研發方面的進展感到非常興奮。現在MCD已經經過臨床驗證。因此它已通過臨床驗證。我們不會等待任何其他測試或測試成為臨床級測試。
We spent some energy and effort to make it operationally ready for patient testing. And now that we have started the Vanguard study labs are running these samples. We are reporting out these clinical reports for patient management within the Vanguard. So from those aspects, we are actually ready. It's not that we are waiting for any kind of pivotal study readout to come before we take any action on broadening access for Shield MCD.
我們花了一些精力和努力,使其能夠為患者測試做好準備。現在我們已經開始讓先鋒研究實驗室運作這些樣本。我們正在報告這些臨床報告,以供先鋒隊內部的病患管理使用。所以從這些方面來看,我們其實已經準備好了。我們並不是在等待任何關鍵研究結果出來後才採取行動擴大 Shield MCD 的存取權限。
As I mentioned in the prepared remarks, hopefully, we can have some conversation about it in the near future. And stay tuned about it.
正如我在準備好的發言中所提到的,希望我們能在不久的將來就此進行一些對話。請繼續關注。
In terms of some [matters], I think, the matters you mentioned, we are very aware of the laws. We are here to help the patients. Never we are going to do something which is against the laws. And I think the way I read about it is the tremendous opportunity that we have with Shield that excites us. I think just over time, would increase.
就某些[事項]而言,我認為,就您提到的事項而言,我們非常了解法律。我們來這裡是為了幫助病人。我們絕不會做違反法律的事。我認為我讀到的關於 Shield 的巨大機會讓我們感到興奮。我認為隨著時間的推移,會增加。
USPSTF very quickly. We are monitoring the situation very closely. Yeah, it looks like the whole panel appears to be -- to get into the process to get replaced. The good success that we had with our Shield in the market right now with a very healthy gross margin and a very big greenfield, which is in front of us. We have a lot of actually opportunity in front of us to mine, build this business while we are waiting for task force guideline inclusion.
USPSTF 非常快。我們正在密切關注局勢發展。是的,看起來整個小組似乎都進入了更換程序。目前,我們的 Shield 在市場上取得了良好的成功,擁有非常健康的毛利率和巨大的發展潛力。在等待工作小組指導方針的納入的同時,我們面前實際上有很多機會去挖掘和發展這項業務。
Operator
Operator
Subbu Nambi, Guggenheim.
蘇布南比 (Subbu Nambi),古根漢美術館。
Subbu Nambi - Equity Analyst
Subbu Nambi - Equity Analyst
Hey, guys. Thank you for taking my question. You had recently said that Reveal was at approximately 1.7 tests per patient. How much do you expect the CRC surveillance reimbursement to drive this number upwards in the near term in 2026? And then in the long run, what do you think this number could look like?
嘿,大家好。感謝您回答我的問題。您最近說過,Reveal 每位患者大約需要進行 1.7 次測試。您預計 2026 年 CRC 監測報銷將在短期內推動這一數字上升多少?那麼從長遠來看,您認為這個數字會是多少?
And I noticed in the catalyst slide, you don't have Reveal ADLT listed. I don't think that was on the slide before, but I'm curious if you have any updates there.
我注意到在催化劑幻燈片中,您沒有列出 Reveal ADLT。我認為之前的幻燈片上沒有這個內容,但我很好奇您是否有任何更新。
Michael Bell - Chief Financial Officer
Michael Bell - Chief Financial Officer
Yeah. No, good question. We're already seeing it drive higher with some of the progress we've made. We've seen not only great traction, as we've said, Reveal is our fastest-growing product on the oncology side, really only second to Shield across the company. And so we're really excited about the progress we've made. We're seeing acceleration there. Really good traction with new patient starts, but even more so with subsequent draws, which is where we hadn't been pushing quite as much.
是的。不,好問題。隨著我們取得的一些進展,我們已經看到它進一步走高。我們不僅看到了巨大的吸引力,正如我們所說,Reveal 是我們在腫瘤學領域成長最快的產品,實際上在整個公司範圍內僅次於 Shield。因此,我們對所取得的進展感到非常興奮。我們看到那裡正在加速發展。對於新病人的開始治療確實有很好的牽引力,但對於後續的治療更是如此,而我們之前並沒有在這方面投入太多精力。
Now that we've turned a lot of that machinery on really sort of -- it's been exciting to see how much we can start to lean into that and really drive that volume. So yeah, I mean, I think the next few quarters and certainly into '26, we have high expectations for Reveal, and we can certainly get that number, I think, up significantly in terms of number of tests per patient.
現在我們已經啟動了很多這樣的機器——看到我們可以在多大程度上依靠它並真正推動產量成長,這令人興奮。是的,我的意思是,我認為在接下來的幾個季度,當然還有 26 年,我們對 Reveal 抱有很高的期望,而且我認為,就每位患者的測試數量而言,我們肯定可以顯著提高這個數字。
In terms of ADLT, that was never on the milestone chart there, but it's certainly something we've submitted for, and we are waiting for decision basically. Hopefully, over the next quarter or so, we'll know the resolution. I think we're very positive. We know that the test qualifies for ADLT. So hopefully, it will come back as a positive.
就 ADLT 而言,這從未出現在里程碑圖表上,但這是我們確實提交的內容,基本上我們正在等待決定。希望在接下來的一個季度左右,我們能夠知道解決方案。我認為我們非常積極。我們知道該測試符合 ADLT 要求。所以希望它能帶來正面的結果。
Operator
Operator
Kyle Mikson, Canaccord.
凱爾米克森(Kyle Mikson),Canaccord。
Kyle Mikson - Equity Analyst
Kyle Mikson - Equity Analyst
Hey, guys. Thanks for the questions. Congrats on a great quarter. Help me, why are you confident that Reveal Medicare reimbursement for breast is going to be obtained faster than CRC, including surveillance for colon that took a while.
嘿,大家好。感謝您的提問。恭喜本季取得優異成績。幫幫我,為什麼你確信 Reveal Medicare 對乳癌的報銷會比 CRC 更快獲得,包括需要一段時間的結腸監測。
And then second for AmirAli, NCCN inclusion was nice, but is that having an impact on Shield volumes or do we need ACS and USPSTF? And then on the point of USPSTF from earlier, if the panel is replaced with people that clinicians don't really trust, is this going to make that milestone for you guys maybe less important?
其次,對於 AmirAli 來說,NCCN 的納入很好,但這會對 Shield 數量產生影響嗎?或者我們是否需要 ACS 和 USPSTF?然後關於之前提到的 USPSTF,如果專家小組被臨床醫生不真正信任的人所取代,這是否會使你們的里程碑變得不那麼重要?
Michael Bell - Chief Financial Officer
Michael Bell - Chief Financial Officer
A lot of questions. The -- in terms of Reveal Medicare coverage, the second time we got for CRC surveillance was actually pretty quick. I think it was just, I think, something like four, five months, which as fast as it really comes in from a submission to sort of coverage. So yes, I mean, obviously, the first time we went through the process, it took a little bit longer. Second time, much, much faster. So I think we have a better sense for what is required from a Medicare point of view.
有很多問題。就揭露醫療保險覆蓋範圍而言,我們第二次獲得 CRC 監測實際上非常快。我認為從提交到報道只需四、五個月的時間。是的,我的意思是,顯然,我們第一次經歷這個過程時,花費的時間要長一點。第二次,速度快很多。因此我認為,從醫療保險的角度來看,我們對需要做什麼有了更好的了解。
Obviously, it's always up to their discretion in terms of what passes the bar or not. But clearly, having gone through the process multiple times now, we have a better sense of what is required. And so yes, we have pretty high confidence around -- we have good confidence around IO in terms of when we finally submit that to MolDx. And we're making good progress on other cohorts as well with Reveal. So it's an exciting pipeline for us.
顯然,什麼能通過標準審查或不能通過標準審查始終由他們自行決定。但顯然,經過多次經歷這個過程後,我們對需要做什麼有了更好的了解。是的,我們對此非常有信心——就我們最終將其提交給 MolDx 而言,我們對 IO 非常有信心。我們在 Reveal 的其他群組中也取得了良好的進展。所以這對我們來說是一個令人興奮的管道。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Regarding NCCN guideline, definitely, it was a surprise, great milestone for us. How much of it is impacting our volume like within this very strong ramp that we are experiencing, it's very hard for us to kind of carve out the impact of each one of these kind of catalysts for us.
關於 NCCN 指南,這對我們來說無疑是一個驚喜,一個偉大的里程碑。在我們所經歷的這種非常強勁的成長勢頭中,它對我們的銷量有多大影響,我們很難弄清楚每種催化劑對我們造成的影響。
But NCCN, again, it's the voice of expert oncologists at the end. So we are very excited with it. And we also continue to be very confident about inclusion by other guidelines, including ACS and USPSTF.
但 NCCN 最終還是代表了腫瘤專家的聲音。所以我們對此感到非常興奮。我們也仍然對包括 ACS 和 USPSTF 在內的其他指南的納入充滿信心。
I think some of the stuff is just common sense. You detect almost all Stage 2 and above CRCs, you can cure or have very long-term survival even if you detect CRC at Stage 2. You want patients to be unscreened and do not detect their cancer. I think some of the stuff is just common sense. But over time, we are going to figure it out, but -- and we were very confident and we remain very confident about guideline inclusion.
我認為其中一些東西只是常識。您可以檢測出幾乎所有 2 期及以上的 CRC,即使您在 2 期檢測到 CRC,您也可以治癒或獲得長期生存。您希望患者不接受篩檢並且檢測不到自己的癌症。我認為其中一些東西只是常識。但隨著時間的推移,我們會弄清楚的,但是——我們非常有信心,我們仍然對指南的納入非常有信心。
Operator
Operator
Dan Arias, Stifel.
丹·阿里亞斯(Dan Arias),Stifel。
Daniel Arias - Analyst
Daniel Arias - Analyst
Hey, guys. Thank you. AmirAli, you were sufficiently vague on that answer to V2 data timing. Is everything squared away on your end and it's just a matter of when you decide to pull back the curtain on the results? Or are there still things that are being worked on there? Sorry to ask again, but hot topic to say the least.
嘿,大家好。謝謝。AmirAli,你對 V2 資料時間的回答相當模糊。您這邊所有事情都安排妥當了嗎?只剩下什麼時候公佈結果的問題了?或者那裡還有正在進行的工作嗎?很抱歉再次詢問,但至少可以說這是一個熱門話題。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
No problem. I understand. So we are not putting a fine point on the exact timing of the V2 data. But as I mentioned, it's a very active program. A lot of work has gone into it.
沒問題。我明白。因此,我們無法精確指出 V2 資料的確切時間。但正如我所提到的,這是一個非常活躍的項目。我們為此付出了很多努力。
It's a lot of work is going into it as we speak. And we'll see like -- on the other side, we do not feel rush to get to this and some of it is really because of commercial success we are seeing by the currently approved product, the V1. It gives us opportunity to balance some of our R&D initiatives like we pulled forward this MSET clinical validation, bringing the lab and operation up for patient reporting, which can open up opportunities for us in near future down the road. And we'll see when we can wrap up this V2 still, we are working on it.
正如我們所說,還有很多工作要做。我們會看到——另一方面,我們並不急於實現這一目標,部分原因實際上是因為我們看到了目前批准的產品 V1 所取得的商業成功。它使我們有機會平衡一些研發計劃,例如我們提前了這項 MSET 臨床驗證,將實驗室和操作納入患者報告範圍,這可以在不久的將來為我們帶來機會。我們將看看何時可以完成這個 V2,我們正在努力。
Operator
Operator
Patrick Donnelly, Citi.
花旗銀行的 Patrick Donnelly。
Patrick Donnelly - Analyst
Patrick Donnelly - Analyst
Hey, guys. Thanks for taking my questions. Maybe one just on the profitability side. Nice to see the gross margins continue to creep higher with the profitability side. As you guys have advertised in the last couple of quarters, you're going to continue to invest that on the sales and marketing side. I mean, Mike, does that speak to just your confidence in the path to real profitability here in the out years, the fact that you are willing to continue to reinvest rather than chase near-term profitability. Can you just talk about the confidence in the balance sheet and again, that path to profitability as you reinvest some of these profit dollars?
嘿,大家好。感謝您回答我的問題。也許只是在獲利方面。很高興看到毛利率隨著獲利能力的提高而持續攀升。正如你們在過去幾個季度所宣傳的那樣,你們將繼續在銷售和行銷方面進行投資。我的意思是,麥克,這是否表明您對未來幾年實現真正盈利的道路充滿信心,並且您願意繼續進行再投資而不是追求短期盈利。您能否談談對資產負債表的信心,以及當您將部分利潤重新投資時實現盈利的途徑?
Michael Bell - Chief Financial Officer
Michael Bell - Chief Financial Officer
Yeah, Patrick. I mean, I think at a high level, at our last Investor Day two years ago, we set this path to profitability of 2028, and we said from then 2023, we would be reducing our cash burn every year. So far, we're on track, well on track with that. Things are going very well. And we remain very confident that we can get to breakeven in 2028.
是的,派崔克。我的意思是,我認為從高層來看,在兩年前的上一次投資者日上,我們設定了 2028 年實現盈利的路線,並且我們表示從 2023 年開始,我們將每年減少現金消耗。到目前為止,我們的進展一切順利。一切進展順利。我們仍然非常有信心在 2028 年達到收支平衡。
On the screening side, we sort of repeatedly said over the next couple of years, we'll manage the burn to something like $200 million, and we'll be very thoughtful about reinvesting the -- any additional gross profit back into the sales and margin line. And I think we're ahead of track the gross profit very strongly in Q2. It's 48% gross margins. And so we're reinvesting that, but that's not increasing our overall burn of the target that we set at the start of the year.
在放映方面,我們曾多次表示,在接下來的幾年裡,我們會將支出控制在 2 億美元左右,我們會非常謹慎地將任何額外的毛利重新投資到銷售和利潤線上。我認為我們第二季的毛利將大幅領先。毛利率為48%。因此,我們正在重新投資,但這並沒有增加我們年初設定的目標的整體消耗。
And so I think we're managing that very well. And it's giving us -- this $200 million burn is giving us everything that we need to really scale that commercial infrastructure as quickly as we can. And if you exclude screening, actually, we're making fantastic progress.
所以我認為我們管理得很好。這 2 億美元的投入為我們提供了盡快擴大商業基礎設施規模所需的一切。事實上,如果不考慮篩檢,我們正在取得巨大進步。
We said earlier on in the year that excluding screening, the rest of the business is on track to be breakeven before the end of the year. And that's still the case. And I think with the traction that we continue to see on ASPs better-than-expected gross margins, we feel really confident on that.
我們在今年稍早就說過,除篩選業務外,其餘業務預計在年底前實現收支平衡。情況至今仍是如此。我認為,隨著我們繼續看到平均銷售價格 (ASP) 和毛利率好於預期,我們對此充滿信心。
So I think from a balance sheet perspective, to profitability, yeah, we're still confident and on track to what we stated in the past.
因此,我認為從資產負債表的角度來看,對於獲利能力來說,是的,我們仍然有信心並且正在朝著我們過去所說的目標前進。
Operator
Operator
Rachel Vatnsdal, JPMorgan.
摩根大通的 Rachel Vatnsdal。
Rachel Vatnsdal - Analyst
Rachel Vatnsdal - Analyst
Perfect. Good afternoon. Thanks so much for taking the question. I wanted to press on Shield V2 a little bit more, but more so around the time lines associated with it. So you previously had talked about hoping to get that launched by year-end. Not really committing to time lines in terms of when we'll see that data. But just given we don't have it yet, can you walk us through your updated assumptions on how long do you think it will take for FDA to review once they do have the data? And are you still on track to launch that by year-end at this point?
完美的。午安.非常感謝您回答這個問題。我想對 Shield V2 進行更多的關注,但更多的是圍繞著與之相關的時間線。所以您之前曾談到希望在年底前推出該產品。我們實際上並沒有承諾何時能看到這些數據。但鑑於我們還沒有得到這些數據,您能否向我們介紹一下您的最新假設:您認為 FDA 在獲得數據後需要多長時間進行審查?目前您是否仍有望在年底前推出此計劃?
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Yes. So I'm not sure how much I can add. But in terms of, yes, the timelines for FDA approval and launch, obviously, it's a function of when we get to the readout and how long it would take FDA to review our package. So we're pleased with a bunch of conversations we had with agency in terms of what they're going to look at and how they're going to look at.
是的。所以我不確定我可以添加多少。但就 FDA 批准和發布的時間表而言,顯然,這取決於我們何時獲得讀數以及 FDA 需要多長時間來審查我們的方案。因此,我們很高興與代理商就他們將關注什麼以及如何關注進行了一系列對話。
Now, how long it's going to take to go through that review process, we have to see how long their process would take. But yeah, but maybe in terms of end of the year, maybe that's fair. Maybe we are delayed a little bit.
現在,審查過程需要多長時間,我們必須看看他們的流程需要多長時間。但是是的,但也許就年底而言,這也許是公平的。也許我們耽擱了一點時間。
But as I mentioned, I don't feel rush to get to that milestone, and it was important for us to balance some of our R&D activities between V2 and MCD, and I'm very pleased with where we are today. And we are working on it very extensively, a lot of work is happening. So -- but maybe it's a little bit delayed.
但正如我所提到的,我並不急於達到這個里程碑,對我們來說,平衡 V2 和 MCD 之間的一些研發活動非常重要,我對我們目前的狀況感到非常滿意。我們正在對此進行廣泛的研究,正在進行大量工作。所以——但可能會有點延遲。
Operator
Operator
Eve Burstein, Bernstein Research.
伊芙·伯斯坦(Eve Burstein),伯恩斯坦研究公司。
Eve Burstein - Equity Analyst
Eve Burstein - Equity Analyst
Great. Thanks so much for taking my questions. A couple on Shield. So now that Shield has had ADLT status for four months, you're through a chunk of the time that you have to get private payers to contract with you. So first, can you give us some color on how those conversations are progressing? I imagine that many private payers don't want to reimburse a test that won't get them quality credit yet. So how are you handling that?
偉大的。非常感謝您回答我的問題。Shield 上的一對夫婦。因此,現在 Shield 已擁有 ADLT 資格四個月了,您必須花大量時間讓私人付款人與您簽訂合約。那麼首先,您能否向我們介紹一下這些對話的進展?我想許多私人付款人不願意報銷無法為他們帶來品質信譽的測試。那你如何處理這個問題?
Second, do you expect to contract with private payers at or close to the ADLT rate? Or is the $920 rate more reasonable, or do you expect it to be below that?
其次,您是否希望與私人付款人簽訂以 ADLT 費率或接近 ADLT 費率簽訂的合約?或者 920 美元的利率更合理,或者您預計利率會低於這個數字?
And then third, you've given us a guide to ASP of $800 for the rest of the year. But how should we think about what happens to ASP next year? Could it actually decrease pretty meaningfully as that rate resets and as the payer mix shifts up a bit?
第三,您為我們提供了今年剩餘時間內 800 美元 ASP 的指南。但我們該如何看待明年 ASP 的趨勢呢?隨著利率重置和付款人結構略有變化,它實際上是否真的會大幅下降?
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
In terms of conversation with private payers, we've been in touch with them. And even after NCCN guideline, we've been in touch with a fraction of commercial payers that we think maybe they would be early adopter. We'll see what happens. We are not counting on any major coverage before getting into ACS and USPSTF guidelines. So we'll see how it goes.
在與私人付款人的對話方面,我們已經與他們取得了聯繫。即使在 NCCN 指南發布之後,我們仍然與一小部分商業付款人保持聯繫,我們認為他們可能是早期採用者。我們將拭目以待。在進入 ACS 和 USPSTF 指南之前,我們不指望任何主要的報道。我們將拭目以待。
In terms of expectation for ADLT rate based on the collections that we are having from Medicare Advantage, we are very confident of keeping our ADLT as what it is today as we go through the next reporting cycle, which is going to start from January of '26 till December of '27. So that 14.95, we are very confident it would remain the same.
根據我們從醫療保險優勢計劃 (Medicare Advantage) 獲得的收益,就對 ADLT 率的預期而言,我們非常有信心在下一個報告週期(從 26 年 1 月開始到 27 年 12 月)內將 ADLT 保持在目前的水平。因此,我們非常有信心 14.95 會保持不變。
In terms of ASP, I think it's going to be a function of the payer mix. I think still we are in the early innings of this commercial execution. We are pleased with how the payer mix is landing at this time, but we are going to monitor it and then we would set expectation for ASP as we get closer to 2026.
就 ASP 而言,我認為它將取決於付款人組合。我認為我們仍處於這項商業執行的早期階段。我們對目前的付款人組合情況感到滿意,但我們將對其進行監控,然後在接近 2026 年時設定對 ASP 的預期。
Operator
Operator
Bill Bonello, Craig-Hallum.
比爾·博尼洛、克雷格·哈勒姆。
Bill Bonello - Analyst
Bill Bonello - Analyst
Hey, guys. Thanks a lot for taking the question. I guess this one is for Helmy, maybe more big picture. Thinking about the traction that you've gotten with Guardant360 Liquid and the paradigm shift from years ago sort of tissue first to the big ramp you've had and the evolution towards people being willing to consider liquid first or looking at doing both. I'm just kind of curious how you might extrapolate that experience to Reveal and sort of this notion that seems to be out there that gosh, there's some superiority to tumor-informed and like tissue or tumor-naïve is fine if you can't get a tissue, but otherwise, you want to do tumor-informed. Could you see sort of a similar evolution? Are you hearing anything from physicians, KOLs in particular, now that leads you to believe that will happen?
嘿,大家好。非常感謝您提出這個問題。我猜這是為 Helmy 準備的,也許更有局觀。想想你們透過 Guardant360 Liquid 獲得的牽引力,以及從幾年前首先考慮組織到現在的巨大轉變,以及人們願意先考慮液體或同時考慮兩者的演變。我只是有點好奇,你會如何將這種經驗推廣到 Reveal 中,以及這種似乎存在的概念,天哪,腫瘤知情有一些優勢,就像組織或腫瘤幼稚一樣,如果你無法獲得組織,那就沒問題,但除此之外,你想做腫瘤知情。你能看到類似的演變嗎?您是否聽過醫生,特別是 KOL 的任何消息,讓您相信這種情況會發生?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yeah, that's a great question. I think that maybe one of the sort of underappreciated aspects of our Infinity platform, the sort of smart liquid biopsy ecosystem is that many of these apps that we're populating on 360 liquid will eventually make their way to 360 tissue and even reveal where appropriate. And so when you think of where a deal could be, it's going to look like a very different sort of product than any tumor-informed product out there that is just looking for sort of passenger mutations or a number of mutations that may not be actionable.
是的,這是一個很好的問題。我認為,也許我們的 Infinity 平台(智慧液體活檢生態系統)的一個被低估的方面是,我們在 360 液體上填充的許多應用程式最終將進入 360 組織,甚至在適當的情況下進行顯示。因此,當您考慮交易可能在哪裡時,它看起來會是一種非常不同的產品,與任何腫瘤資訊產品不同,這些產品只是在尋找某種乘客突變或一些可能無法採取行動的突變。
And we're actually seeing the biology that is there in that individual, things like the subtype, how that's evolving, the potentially even toxicity from some of the adjuvant therapy that they're being exposed to. It really opens up a different space, which is why we've said that the MRD market will likely have two aspects to it. There will be a tumor-informed sort of market that some physicians would like to use. And there's going to be, I think, a pretty massive tissue-free aspect to it in market, too.
我們實際上正在觀察該個體的生物學特性,例如亞型、其演變方式,以及他們所接觸的一些輔助療法的潛在毒性。它確實開闢了一個不同的空間,這就是為什麼我們說 MRD 市場可能有兩個面向。將會有一個腫瘤資訊市場,一些醫生願意利用它。而且我認為,它在市場上也將佔有相當大的份額,無需使用紙巾。
Just like there is in comprehensive genomic profiling, there's two big markets there. And I would argue that the liquid market in CGP, I think few would argue is ultimately going to be massively bigger than the tissue market. And we potentially see the same dynamic shaping up on the MRD side.
就像綜合基因組分析一樣,那裡有兩個大市場。我認為,幾乎沒有人會認為 CGP 的流動性市場最終會比紙巾市場大得多。我們可能會看到 MRD 方面也出現同樣的動態。
Operator
Operator
Yuko Oku, Morgan Stanley.
奧裕子,摩根士丹利。
Yuko Oku - Analyst
Yuko Oku - Analyst
Hello. Thank you for taking my question. The recent SERENA-6 readout provides a compelling argument to monitor emergence of ESR mutation for treatment with camizestrant. What do you think may be the split at steady state to monitor emergence of ESR1 mutation between comprehensive panel like G360 versus hotspot tests?
你好。感謝您回答我的問題。最近的 SERENA-6 讀數為監測 ESR 突變的出現以便用卡米司群治療提供了令人信服的論點。您認為在穩定狀態下,監測 ESR1 突變的出現,在 G360 等綜合面板和熱點測試之間可能存在什麼差異?
And also with cuts to Medicaid, what is your view on the impact to cancer testing more broadly?
另外,隨著醫療補助的削減,您認為這對癌症檢測的更廣泛影響是什麼?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yeah. So we really see this as a beachhead for a new paradigm in essentially oncology that will ultimately be the paradigm that I think all patients are monitored and treated with. And the point is ESR1 is the first of what we think will be many opportunities to switch therapies dynamically, really this idea of adaptive management of disease.
是的。因此,我們確實將此視為腫瘤學新範式的灘頭陣地,我認為這最終將成為所有患者都受到監測和治療的範式。重點是,我們認為 ESR1 是動態切換療法的眾多機會中的第一個,這實際上是一種適應性疾病管理的概念。
And the camizestrant example, we are the enrolling assay. We will be -- if it gets approved, the official CDx for that, at least in the United States. And so I think we have a very good chance of not only opening the door in this new paradigm, but capitalizing on the majority of the opportunity and volume that would be there in the first couple of years. So we see it as, I think, a very significant upside opportunity on G360 volumes in the future.
以 camizestrant 為例,我們正在進行註冊分析。如果獲得批准,我們將成為該檢測的官方伴隨診斷,至少在美國是如此。因此我認為我們不僅有很好的機會打開這個新模式的大門,而且還可以利用前幾年的大部分機會和數量。因此,我認為,我們認為這是未來 G360 銷售的一個非常重要的上升機會。
Zarak Khurshid - Vice President, Investor Relations
Zarak Khurshid - Vice President, Investor Relations
One more question, please, operator.
接線員,請再問一個問題。
Operator
Operator
Luke Sergott, Barclays.
巴克萊銀行的盧克‧塞戈特 (Luke Sergott)。
Salem Salem - Analyst
Salem Salem - Analyst
This is Salem Salem on for Luke. Thanks for squeezing us in here. Just kind of piggybacking off of a question before, I guess, on Medicaid, could you give us an update on what your exposure is to those volumes, if possible, by test, which I realize is a tall order. And if not, kind of ballpark numbers just given the expected fallout of the big beautiful bill? And what do you kind of expect on pacing of any potential headwinds this year or next year?
這是盧克的塞勒姆·塞勒姆。感謝您讓我們擠在這裡。我想,這只是之前關於醫療補助的一個問題,您能否透過測試告訴我們您接觸這些物質的情況,如果可能的話,我知道這是一個很高的要求。如果不是,那麼考慮到這項大法案的預期後果,大概的數字是多少?您對今年或明年可能遇到的不利因素有何預期?
Michael Bell - Chief Financial Officer
Michael Bell - Chief Financial Officer
Yeah, I can take that one. I mean, very simply, Medicaid volume is very, very minimal in our overall volume across all products and even less so on the revenue side. So any impact overall to Medicaid isn't really going to have any impact on our overall volume or revenue.
是的,我可以接受這個。我的意思是,很簡單,醫療補助的額度在我們所有產品的總量中所佔比例非常小,在收入方面就更少了。因此,對醫療補助計劃的整體影響實際上不會對我們的整體業務量或收入產生任何影響。
Operator
Operator
That concludes the conference call. Thank you for your participation. Enjoy the rest of your day.
電話會議到此結束。感謝您的參與。享受剩餘的一天。