使用警語:中文譯文來源為 AI 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good afternoon. Thank you for attending the Guardant Health Q1 2026 earnings call. My name is Matt, and I'll be the moderator for today's call. (Operator Instructions)
下午好。感謝您參加 Guardant Health 2026 年第一季財報電話會議。我叫 Matt,將擔任今天會議的主持人。(接線員指示)
I'd now like to pass the conference over to our host, Zarak Khurshid, VP of Investor Relations. Zarak, please go ahead.
現在我想把會議交給我們的主持人——投資人關係副總裁 Zarak Khurshid。Zarak,請開始。
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 March 31, 2026. Joining me today from Guardant are Helmy Eltoukhy, Co-CEO; AmirAli Talasaz, Co-CEO; and Mike Bell, Chief Financial Officer.
謝謝。今天稍早,Guardant Health 公布了截至 2026 年 3 月 31 日止季度的財務結果。今天與我一同出席的 Guardant 團隊成員包括共同執行長 Helmy Eltoukhy、共同執行長 AmirAli Talasaz,以及財務長 Mike Bell。
Before we begin, I'd like to remind you that during this call, we 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 to most directly comparable GAAP financial measures are available in the press release Guardant issued today as well as in our 10-Q and other filings with the SEC.
在開始之前,我想提醒各位,本次電話會議中我們將在聯邦證券法的意義下作出前瞻性陳述。這些陳述涉及重大風險與不確定性,可能導致實際結果或事件與預期存在重大差異。本次電話會議亦將討論非 GAAP 財務衡量指標,該等指標經調整以排除若干特定項目。有關重大風險與不確定性的更多資訊,以及非 GAAP 財務指標與最直接可比 GAAP 財務指標之調節表,均載於 Guardant 今日發布的新聞稿,以及我們向 SEC 提交的 10-Q 與其他申報文件中。
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. The information in this conference call is accurate only as of the live broadcast.
除法律要求外,Guardant 不承擔更新或修訂財務預測與前瞻性陳述的任何意圖或義務,不論係因新資訊、未來事件或其他原因。本次電話會議中的資訊僅截至直播當時為準。
With that, I would like to turn the call over to Helmy.
接下來,我想把電話會議交給 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 first-quarter 2026 earnings call.
謝謝你,Zarak。下午好,感謝各位參加我們 2026 年第一季財報電話會議。
Starting on slide 3, we entered 2026 with significant momentum that accelerated through Q1, driving a remarkable quarter for Guardant Health. These results validate our strategic vision of delivering increasingly more actionable insights to physicians and patients across the care continuum. Notably, our commercial flywheel has achieved a new level of velocity, delivering our fastest year-over-year percentage revenue growth in the last five years and surpassing the $1 billion trailing 12-month revenue milestone. This is a testament to the burgeoning scale and long-term durability of our business.
從第 3 張投影片開始,我們以強勁動能進入 2026 年,並在第一季持續加速,推動 Guardant Health 交出亮眼的一季。這些成果驗證了我們的策略願景:在照護全流程中,為醫師與病患提供愈來愈多可採取行動的洞見。值得注意的是,我們的商業飛輪已達到新的運轉速度,創下過去五年最快的年對年營收成長率,並突破過去 12 個月(TTM)營收 10 億美元的里程碑。這證明了我們業務規模的快速擴張,以及長期的韌性與耐久性。
Before I share our results in more detail, I'd like to share a story that illustrates the real-world impact of our tests. A 77-year-old Atlanta resident recently completed a Shield CRC test. The results came back positive and the patient underwent a diagnostic colonoscopy during which a lesion was discovered and biopsied. The lesion was subsequently confirmed to be malignant by pathology. The patient then underwent surgical resection of the malignant lesion, which was confirmed to be highly localized.
在我更詳細分享業績之前,我想先分享一個故事,說明我們檢測在真實世界中的影響。一位 77 歲的亞特蘭大居民近期完成了 Shield CRC 檢測。結果呈陽性,病患隨後接受診斷性大腸鏡檢查,期間發現病灶並進行切片。之後病理檢驗確認該病灶為惡性。病患接著接受惡性病灶的外科切除,並確認病灶高度局限。
The patient welcomed this news from her oncologist and was further relieved that no additional treatment was necessary. Patient outcomes like this are one of the many reasons we have benefited from accelerating adoption and growth.
病患從其腫瘤科醫師處得知此消息後感到欣慰,也更放心的是不需要任何額外治療。像這樣的病患結果,是我們得以受惠於採用加速與成長的眾多原因之一。
Turning to our revenue performance on slide 4. We had a phenomenal start to 2026, delivering $302 million of revenue in Q1, representing 48% year-over-year growth. The growth was strong and broad-based across our oncology, biopharma and data and screening business lines.
接著看第 4 張投影片的營收表現。我們在 2026 年有個極佳的開局,第一季營收達 3.02 億美元,年對年成長 48%。成長動能強勁且涵蓋面廣,遍及我們的腫瘤、生物製藥與資料,以及篩檢等業務線。
Taking a closer look at our oncology business on slide 5. Oncology revenue growth accelerated to 36% year over year, driving Q1 revenue of $205 million. Oncology test volumes rose 47% to approximately 86,000 tests, up from 59,000 in the prior year period. This was the highest year over year percentage growth in oncology volume we've seen in nearly three years with strength across all products. We're excited to see the expanding role of our portfolio across the cancer care continuum.
再更深入看第 5 張投影片的腫瘤業務。腫瘤營收年對年成長加速至 36%,帶動第一季營收達 2.05 億美元。腫瘤檢測量年對年成長 47% 至約 86,000 次檢測,高於去年同期的 59,000 次。這是我們近三年來所見最高的腫瘤檢測量年對年百分比成長,且各產品皆表現強勁。我們很高興看到我們的產品組合在癌症照護全流程中的角色持續擴大。
Turning to slide 6. Our 47% year over year volume growth reflects the increasing breadth of our portfolio across both therapy selection and MRD. Guardant360 Liquid delivered 30% volume growth year over year, while Guardant360 Tissue was our second fastest-growing product. Smart platform innovation continues to translate directly into volume growth for both products with Infinity AI powering a steady cadence of new clinical applications that are driving deeper adoption among oncologists.
接著看第 6 張投影片。我們年對年 47% 的檢測量成長,反映出我們產品組合在治療選擇與 MRD(微量殘存病灶)兩大領域的覆蓋面持續擴大。Guardant360 Liquid 檢測量年對年成長 30%,而 Guardant360 Tissue 則是我們成長第二快的產品。Smart 平台的創新持續直接轉化為兩項產品的檢測量成長;Infinity AI 以穩定的節奏推出新的臨床應用,推動腫瘤科醫師更深度採用。
We have a strong pipeline of additional smart apps in development, and we look forward to continuing that cadence. Reveal remained our fastest-growing product with volumes up over 100% year over year, reflecting strong adoption of Reveal in MRD across indications and enthusiasm for our new therapy response monitoring use case among our customers in its first full quarter post launch.
我們仍有多項額外的 smart apps 正在開發中,並期待延續這樣的推出節奏。Reveal 仍是我們成長最快的產品,檢測量年對年成長超過 100%,反映 Reveal 在多種適應症的 MRD 應用上採用強勁,以及客戶對我們新推出的治療反應監測使用情境的高度興趣——這也是該功能上市後的第一個完整季度。
Moving on to slide 7. With each patient tested, our data treasury continues to deepen and diversify. Our data repository harnesses insights from over 1 million patient samples, 500,000 epigenetic profiles across more than 100 tumor types, and each new sample helps compound the breadth and uniqueness of what we can deliver over time.
接著看第 7 張投影片。隨著每位病患接受檢測,我們的資料寶庫持續加深並更加多元。我們的資料庫匯聚了超過 100 萬份病患樣本、涵蓋 100 多種腫瘤類型的 50 萬份表觀遺傳(epigenetic)圖譜;而每一份新增樣本都會隨時間推進,進一步累積我們可提供之洞見的廣度與獨特性。
By applying our Infinity AI learning engine to this expanding data mode, we uncover novel biological signatures, power new smart app development and accelerate therapeutic discovery for our biopharma partners. The result is a compounding flywheel wherein data drives better insights, which in turn fuels volume growth and strengthens our data advantage.
透過將我們的 Infinity AI 學習引擎應用於這個持續擴大的資料模式,我們得以發掘新的生物學特徵、驅動新的 smart app 開發,並為我們的生物製藥合作夥伴加速治療藥物的發現。其結果是一個複利式的飛輪:資料帶來更佳洞見,進而推動檢測量成長並強化我們的資料優勢。
Turning to slide 8 to take a closer look at our Reveal data pipeline. We continue to make strong progress in generating and publishing compelling data across multiple cancer types and indications. We have submitted data packages to MolDx to support coverage in breast cancer surveillance, immuno-oncology monitoring and chemotherapy monitoring, and we are engaging constructively with MolDx through the review process.
接著看第 8 張投影片,更深入了解我們的 Reveal 資料管線。我們持續在多種癌症類型與適應症上產出並發表具說服力的資料,進展良好。我們已向 MolDx 提交資料套件,以支持乳癌監測、免疫腫瘤監測與化療監測的給付涵蓋,並在審查流程中與 MolDx 進行建設性的互動。
Each submission represents a potentially meaningful reimbursement catalyst, and we are excited about the ASP upside that favorable outcomes would unlock. We are also advancing our work towards the MolDx submission for CDK4/6 inhibitor monitoring.
每一次提交都可能成為具意義的報銷催化劑,我們也對有利結果可帶來的 ASP(平均售價)上行空間感到振奮。我們也正推進針對 CDK4/6 抑制劑監測的 MolDx 提交準備工作。
Looking further ahead, we have ongoing studies across more than five additional tumor types in both the adjuvant and surveillance settings. The breadth of this pipeline gives us real confidence in Reveal's trajectory and its expanding role across the cancer care continuum.
展望更長期,我們在輔助治療(adjuvant)與監測(surveillance)情境中,針對另外超過五種腫瘤類型持續進行研究。這條管線的廣度讓我們對 Reveal 的發展軌跡及其在癌症照護全流程中日益擴大的角色充滿信心。
Turning to slide 9. We continue to make strong progress across the Guardant360 portfolio on multiple fronts. For Guardant360 Liquid, our FDA review remains on track. When approved, Guardant360 Liquid will become the most comprehensive FDA-approved liquid biopsy for therapy selection on the market. Moreover, this development will help simplify ordering across our therapy selection portfolio and create better connectivity across our larger testing ecosystem.
接著看第 9 張投影片。我們在 Guardant360 產品組合的多個面向持續取得良好進展。就 Guardant360 Liquid 而言,我們的 FDA 審查仍按計畫推進。一旦獲准,Guardant360 Liquid 將成為市場上用於治療選擇、最全面的 FDA 核准液體活檢。此外,這項進展將有助於簡化我們治療選擇產品組合的下單流程,並在我們更大的檢測生態系中建立更佳的連結性。
On the tissue side, we are excited to announce our second major platform upgrade in less than a year, expanding RNA testing to whole transcriptome. This further builds on the genomic and epigenomic foundation of our smart platform, and we believe reinforces Guardant360 Tissue's position as best-in-class in the tissue CGP market. We expect these upgrades to be a meaningful volume catalyst for both liquid and tissue, particularly as it opens the door to converting current nonusers.
在組織檢測方面,我們很高興宣布在不到一年的時間內完成第二次重大平台升級,將 RNA 檢測擴展至全轉錄組。這進一步建立在我們智慧平台的基因體與表觀基因體基礎之上,我們相信也強化了 Guardant360 Tissue 在組織 CGP 市場中同級最佳的地位。我們預期這些升級將成為液體與組織檢測的有意義量能催化劑,特別是因為它為轉化目前的非使用者打開了大門。
Turning to slide 10. Guardant had another strong showing at AACR this year. Together with our independent collaborators, 38 abstracts were presented spanning our entire oncology portfolio. The depth of the Smart App data was remarkable. 25 of the abstracts featured Infinity AI generated findings, which speaks to how rapidly this platform is maturing.
接著看第 10 張投影片。Guardant 今年在 AACR 再次有亮眼表現。我們與獨立合作夥伴合計發表了 38 篇摘要,涵蓋我們完整的腫瘤學產品組合。Smart App 的資料深度令人印象深刻。其中 25 篇摘要呈現了由 Infinity AI 產生的發現,顯示該平台正快速成熟。
We were particularly encouraged to see concrete evidence of Infinity AI enabling therapeutic response prediction and improving detection of clinically challenging alterations like ALK-fusions and MTAP deletions. These are exactly the kind of insights unlocked by our data treasury and [epigenomic] capabilities that truly differentiate our platform.
我們尤其受到鼓舞的是,看到 Infinity AI 在治療反應預測方面提供了具體證據,並改善了對臨床上具挑戰性變異(如 ALK 融合與 MTAP 缺失)的偵測。這些正是由我們的資料寶庫與[表觀基因體]能力所解鎖的洞見,真正讓我們的平台具備差異化優勢。
Shifting gears to our biopharma and data business on slide 11. We delivered another strong quarter with revenue growing 17% year over year to $53 million. The last few months have been highly productive with respect to our CDx strategy, which included Guardant360 CDx FDA approval for Pfizer's Braftovi in BRAF V600E-mutant metastatic colorectal cancer and this week's CDx FDA approval with Arvinas and Pfizer's VEPPANU for ER+/HER2- ESR1 mutated advanced breast cancer.
接著轉到第 11 張投影片,談我們的生物製藥與資料業務。我們再度交出強勁的一季,營收年增 17% 至 5,300 萬美元。過去幾個月在 CDx 策略方面成果豐碩,包括 Guardant360 CDx 取得 FDA 核准,作為輝瑞 Braftovi 用於 BRAF V600E 突變轉移性大腸直腸癌的伴隨診斷;以及本週與 Arvinas 與輝瑞的 VEPPANU 相關 CDx 也獲 FDA 核准,用於 ER+/HER2-、ESR1 突變之晚期乳癌。
Our CDx franchise now spans 26 approvals across the US, Japan and Europe, backed by a robust pipeline across multiple partnerships with leading biopharma companies. In the quarter, real-world evidence generated from Infinity AI as supplemental data alongside clinical findings contributed to the first tumor-agnostic approval of Daiichiâs Sankyo's ENHERTU in Japan. We also saw further strengthening of our relationships with leading biopharma companies, including a multiyear agreement with Merck to develop companion diagnostics and commercialize novel therapies as well as last week's announced collaboration with Nuvalent to develop companion diagnostics with an initial focus on Guardant360 Tissue.
我們的 CDx 版圖目前已涵蓋美國、日本與歐洲共 26 項核准,並由與多家領先生物製藥公司合作的強健管線所支撐。本季,Infinity AI 產生的真實世界證據作為臨床發現之外的補充資料,促成第一個在日本獲得與腫瘤類型無關(tumor-agnostic)核准的第一三共 ENHERTU。我們也看到與領先生物製藥公司的關係進一步深化,包括與默克簽署多年期協議以開發伴隨診斷並商業化新型療法,以及上週宣布與 Nuvalent 合作開發伴隨診斷,初期聚焦於 Guardant360 Tissue。
Together, these developments reflect the growing strategic value of our smart platform and Infinity AI to leading biopharma companies and reinforce our confidence in sustained growth in this business.
綜合而言,這些進展反映出我們的智慧平台與 Infinity AI 對領先生物製藥公司的策略價值日益提升,也強化了我們對此業務可持續成長的信心。
With that, I'll now turn the call over to AmirAli for an update on screening.
接下來,我把電話會議交給 AmirAli,請他更新篩檢業務的進展。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Thanks, Helmy. Moving on to slide 12. Q1 was another strong quarter for Shield. We delivered $42 million of Shield testing revenue driven by approximately 44,000 tests compared to $6 million revenue and approximately 9,000 tests in Q1 of 2025. Revenue growth has closely tracked volume growth, reflecting favorable collections and a disciplined focus on reimbursable lives. Now roughly 18 months into the commercial launch, we continue to break records and look forward to sustained strong growth throughout the remainder of 2026.
謝謝你,Helmy。接著看第 12 張投影片。第一季對 Shield 而言又是強勁的一季。我們實現 Shield 檢測營收 4,200 萬美元,約由 44,000 次檢測所帶動;相較之下,2025 年第一季為 600 萬美元營收與約 9,000 次檢測。營收成長與量能成長高度一致,反映出良好的收款表現,以及我們對可獲償付人群(reimbursable lives)的紀律性聚焦。商業化上市約 18 個月以來,我們持續刷新紀錄,並期待在 2026 年剩餘期間維持強勁成長。
Moving to slide 13 for a closer look at Q1 screening highlights. We saw strong volume throughout the quarter and exited the quarter with accelerated momentum in March, which gives us real confidence in our trajectory for the remainder of the year. Our growth was fueled by continued improvement in sales rep productivity and amplified by a series of marketing initiatives that came together in the quarter. We launched our DTC and influencer campaigns in conjunction with colorectal cancer awareness month, including our national campaign with Patrick Dempsey, which I will cover on the next slide.
接著看第 13 張投影片,更深入檢視第一季篩檢重點。我們整季量能表現強勁,並在 3 月以加速動能結束本季,這讓我們對今年剩餘時間的發展軌跡充滿信心。成長動能來自業務代表生產力的持續提升,並受到本季整合推出的一系列行銷活動所放大。我們配合大腸直腸癌宣導月推出 DTC 與網紅行銷活動,包括與 Patrick Dempsey 合作的全國性活動,我會在下一張投影片說明。
Our Quest collaboration launched nationwide in late Q1, and we are pleased with the early signals. Quest is already opening doors for us in health systems and physician practices where we did not previously have a strong direct presence. Shield continues to demonstrate a high adherence rate of over 90%, which is one of the key differentiators of Shield versus other noninvasive modalities. Finally, we launched Shield Multi-Cancer Detection in Asia through our partnership with Manulife, extending our reach into an important new market segment.
我們與 Quest 的合作在第一季末於全美上線,我們對初期訊號感到滿意。Quest 已經在我們過去缺乏強勢直營據點的醫療體系與醫師診所,為我們打開了大門。Shield 持續展現超過 90% 的高依從率,這是 Shield 相較其他非侵入性方式的關鍵差異化之一。最後,我們透過與 Manulife 的合作在亞洲推出 Shield 多癌種偵測(Multi-Cancer Detection),將觸角延伸至一個重要的新市場區隔。
Taking a closer look at our direct-to-consumer programs on slide 14. Q1 marked our first comprehensive DTC campaign spanning TV, digital and influencer channels and the results exceeded our expectations. Together, these efforts generated over 1 billion impressions. The centerpiece was our partnership with Patrick Dempsey, actor and a cancer advocate, who shared his personal experience using Shield during colorectal cancer awareness month. We saw a meaningful step-up in consumer engagement, including website traffic and consumer-initiated provider engagements, which we expect to translate into greater adoption of Shield.
接著看第 14 張投影片,更仔細說明我們的直接面向消費者(DTC)計畫。第一季是我們首次涵蓋電視、數位與網紅渠道的完整 DTC 活動,成果超出預期。這些努力合計帶來超過 10 億次曝光。核心亮點是我們與演員、同時也是癌症倡議者的 Patrick Dempsey 合作,他在大腸直腸癌宣導月分享了自己使用 Shield 的親身經驗。我們看到消費者互動顯著提升,包括網站流量與由消費者主動發起的醫療提供者互動,我們預期這將轉化為 Shield 更高的採用率。
Turning to slide 15. Complementing our DTC program, we have expanded our health care provider marketing initiatives, which drove record HCP engagement in Q1. Our March campaign featured targeted messaging to about 200,000 HCPs emphasizing that many millions of Americans remain unscreened and that Shield is the only FDA-approved blood test for CRC screening with Medicare coverage. Also, we continue to make great progress to enhance physician and patient experience. We are rapidly expanding the number of accounts with direct integration into their Epic eClinicalWorks and Athenahealth EMR systems.
接著看第 15 張投影片。作為 DTC 計畫的互補,我們擴大了醫療照護提供者(HCP)行銷推廣,帶動第一季 HCP 互動創下新高。我們 3 月的活動針對約 200,000 名 HCP 傳遞重點訊息,強調仍有數以千萬計的美國人尚未接受篩檢,而 Shield 是唯一獲 FDA 核准且有 Medicare 給付的大腸直腸癌(CRC)篩檢血液檢測。此外,我們也持續大幅推進醫師與病患體驗的提升。我們正快速擴增可直接整合其 Epic、eClinicalWorks 與 Athenahealth EMR 系統的客戶數量。
Moreover, we officially launched our collaboration with Quest Diagnostic nationwide in late Q1, which has fast tracked our EMR connectivity to more than 650,000 HCPs. We expect this to meaningfully increase depth of ordering among connected physicians. Quest national sales team has now started actively promoting Shield. While still early days, we are pleased with positive contributions we are seeing.
此外,我們在第一季末正式於全美推出與 Quest Diagnostic 的合作,這使我們的 EMR 連線加速擴展至超過 650,000 名 HCP。我們預期這將顯著提升已連線醫師的下單深度。Quest 的全國銷售團隊現已開始積極推廣 Shield。雖然仍在初期階段,但我們對目前看到的正向貢獻感到滿意。
Finally, our patient navigation team is actively helping practices connect patients to convenient phlebotomy access, utilizing our nationwide network of 40,000 phlebotomists as well as Quest 8,000 patient service centers.
最後,我們的病患導航團隊正積極協助診所為病患連結便利的採血服務,運用我們全美 40,000 名採血員的網路,以及 Quest 的 8,000 個病患服務中心。
Turning to slide 16. At Guardant Health, we are dedicated to continuous improvement of our products and patient experience. We are excited to report that we recently received FDA approval to reduce the amount of blood collected from patients to process Shield test to 2-tubes from the original 4-tube kit. We applaud the FDA for their continuous collaboration and dedication to strong patient outcomes.
接著看第 16 張投影片。在 Guardant Health,我們致力於持續改善產品與病患體驗。我們很高興報告,近期已獲 FDA 核准,將 Shield 檢測所需的採血量從原本 4 管套組降低為 2 管即可處理。我們讚許 FDA 持續合作並致力於促進良好的病患結果。
Moving to slide 17. 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. When a physician orders Shield for CRC screening, they can opt in to receive multi-cancer detection results report. The Shield MCD report is available to Shield CRC patients who authorized the release of their medical records to Guardant.
接著看第 17 張投影片。我們的目標一直是要在最可治療的早期階段偵測多種癌症。基於此,我們將 Shield 開發為多癌種偵測(Multi-Cancer Detection)平台。當醫師為大腸直腸癌(CRC)篩檢開立 Shield 時,可選擇同時接收多癌種偵測結果報告。Shield MCD 報告提供給已授權 Guardant 釋出其病歷資料的 Shield CRC 病患。
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. The MCD report covers finding across nine additional cancer types behind CRC, including lung, breast, ovarian, pancreatic and others. We are encouraged by HCP and patient response to this data collection initiatives and the strong opt-in that we are seeing. As a result, we believe we are building what will quickly become the largest clinical database of Multi-Cancer Detection outcomes from patients in the United States.
此項倡議的啟動建立了一個可擴展的臨床數據生成平台,使我們能夠評估在病患照護中對 MCD 結果的使用情況,並提供一條新的途徑以擴大病患對多癌種檢測的可及性。MCD 報告涵蓋在 CRC 之外另外九種癌症類型的發現,包括肺癌、乳癌、卵巢癌、胰臟癌等。我們對醫療照護專業人員(HCP)與病患對此數據收集倡議的回應,以及我們所看到的強勁自願參與(opt-in)感到鼓舞。因此,我們相信我們正在建立一個將迅速成為美國病患多癌種檢測結果最大臨床資料庫的基礎。
Now on to slide 18. During Q1, we announced the expansion of Shield multi-cancer detection in Asia through our partnership with Manulife. Manulife serves more than 13 million customers across Asia. We initially launched in three key markets: Hong Kong, the Philippines, and Singapore. This is a differentiated go-to-market strategy, which leverages a direct channel to a large member base within those markets.
接下來看第 18 張投影片。在第一季,我們宣布透過與宏利(Manulife)的合作,將 Shield 多癌種檢測擴展至亞洲。宏利在亞洲服務超過 1,300 萬名客戶。我們最初在三個關鍵市場推出:香港、菲律賓與新加坡。這是一項差異化的上市策略,利用在這些市場中可直接觸及龐大會員基礎的通路。
With that, I will now turn the call over to Mike for more detail on our financials.
接下來,我將把電話會議交給 Mike,請他更詳細說明我們的財務狀況。
Michael Bellisario - Analyst
Michael Bellisario - Analyst
Thanks, AmirAli. Moving to slide 19. I'll now review our first quarter 2026 financial results. Unless otherwise noted, all growth rates are year over year. Total revenue in Q1 increased 48% to $302 million, reflecting strong growth and continued momentum across Oncology, Biopharma & Data and Screening.
謝謝你,AmirAli。我們來看第 19 張投影片。我現在將回顧我們 2026 年第一季的財務結果。除非另有說明,所有成長率皆為年對年(YoY)。第一季總營收成長 48% 至 3.02 億美元,反映腫瘤、Biopharma & Data 以及篩檢業務的強勁成長與持續動能。
Starting with Oncology. Revenue increased 36% to $205 million. We reported approximately 86,000 oncology tests in the quarter, representing 47% volume growth with broad-based strength across the portfolio. Guardant360 Liquid volumes grew 30%, supported by expanding clinical utility and continued traction of our Smart Apps. Guardant360 Tissue also continued to scale and remains our second fastest-growing oncology product.
先從腫瘤業務開始。營收成長 36% 至 2.05 億美元。本季我們報告約 86,000 次腫瘤檢測,檢測量成長 47%,且產品組合各項皆展現廣泛的強勢表現。Guardant360 Liquid 檢測量成長 30%,受益於臨床效用的擴大以及我們 Smart Apps 的持續推進。Guardant360 Tissue 也持續擴張規模,並仍是我們成長速度第二快的腫瘤產品。
Reveal remains our fastest-growing oncology product with volume growth exceeding 100%, reflecting strong adoption in MRD and continued expansion in therapy response monitoring following its Q4 2025 launch.
Reveal 仍是我們成長最快的腫瘤產品,檢測量成長超過 100%,反映其在 MRD 的強勁採用,以及在 2025 年第四季推出後,於治療反應監測方面的持續擴展。
Average selling prices were stable sequentially with Guardant360 Liquid in the range of $3,000 to $3,100, Guardant360 Tissue above $2,000 and Reveal between $600 and $700. As a reminder, we've submitted data packages to MolDx for Medicare reimbursement covering breast MRD and both immunotherapy and chemotherapy response monitoring. Favorable outcomes from these submissions will provide upside to Reveal ASP.
平均售價(ASP)較前一季維持穩定:Guardant360 Liquid 約在 3,000 至 3,100 美元區間,Guardant360 Tissue 高於 2,000 美元,Reveal 介於 600 至 700 美元。提醒一下,我們已向 MolDx 提交資料套件,以申請 Medicare 給付,涵蓋乳癌 MRD 以及免疫治療與化學治療的反應監測。這些提交若獲得有利結果,將為 Reveal 的 ASP 帶來上行空間。
Biopharma & Data revenue was $53 million, up 17%, reflecting sustained demand and continued strength across sample testing, companion diagnostic projects and data products. In Screening, Q1 revenue was $42 million compared to $6 million in the prior year period. The increase was primarily driven by approximately 44,000 Shield tests in the quarter compared to approximately 9,000 in the prior year period. Volume tracked in line with expectations through January and February. And following the launch of our Quest partnership and successful HCP and DTC programs during colorectal cancer awareness month, we saw clear momentum build through March and exited the quarter strongly.
Biopharma & Data 營收為 5,300 萬美元,成長 17%,反映樣本檢測、伴隨診斷專案與數據產品的需求持續,以及整體表現的延續性強勁。在篩檢方面,第一季營收為 4,200 萬美元,去年同期為 600 萬美元。成長主要由本季約 44,000 次 Shield 檢測所帶動,去年同期約為 9,000 次。1 月與 2 月的檢測量符合預期。而在我們與 Quest 的合作夥伴關係啟動後,加上於大腸直腸癌宣導月期間成功推動 HCP 與 DTC 計畫,我們看到 3 月動能明顯增強,並以強勁表現結束本季。
Shield ASPs increased significantly year over year, reflecting the Medicare rate step-up from $920 to $1,495 that went into effect on April 1, 2025, following Shields ADLT designation. As a reminder, after the initial 9-month period of list price-based reimbursement, Shield transitioned to market-based pricing at the start of 2026.
Shield 的 ASP 年對年顯著提升,反映在 Shield 取得 ADLT 資格後,Medicare 費率自 2025 年 4 月 1 日起由 920 美元調升至 1,495 美元。提醒一下,在最初 9 個月以定價表(list price)為基礎的給付期間之後,Shield 於 2026 年初轉為以市場為基礎的定價(market-based pricing)。
Based on Commercial and Medicare Advantage payments received in 2025, the $1,495 Medicare fee-for-service rate is now established for 2026 and 2027. Out-of-period revenue in Q1 was broadly consistent with quarterly trends over the past year and totaled $22 million, which consisted of $18 million Oncology revenue and $4 million Screening revenue.
根據 2025 年收到的商業保險與 Medicare Advantage 付款,1,495 美元的 Medicare 按服務計費(fee-for-service)費率現已確立,適用於 2026 與 2027 年。第一季的跨期收入(out-of-period revenue)大致與過去一年各季趨勢一致,合計為 2,200 萬美元,其中包含 1,800 萬美元的腫瘤收入與 400 萬美元的篩檢收入。
Turning to slide 20. Non-GAAP gross margin was 66% in Q1 2026, up from 65% in the prior year period. The improvement was primarily driven by lower Guardant360 Liquid cost per test reflecting the ongoing transition to NovaSeq X, which will be completed in May 2026. The transition reduced Guardant360 Liquid sequencing cost per test by nearly $200 versus Q1 2025. We also benefited from improved screening gross margins, which I'll discuss on the next slide.
接著看第 20 張投影片。2026 年第一季非 GAAP 毛利率為 66%,高於去年同期的 65%。改善主要來自 Guardant360 Liquid 單次檢測成本下降,反映我們持續轉換至 NovaSeq X 的進程,該轉換將於 2026 年 5 月完成。相較於 2025 年第一季,此轉換使 Guardant360 Liquid 的每次檢測定序成本降低近 200 美元。我們也受益於篩檢毛利率的改善,我將在下一張投影片說明。
Non-GAAP operating expenses were $268 million, an increase of 34%, primarily driven by commercial investment. While R&D and G&A saw modest year-over-year increases, sales and marketing expense rose to $154 million in Q1 2026 compared to $94 million in the prior year period. This reflects continued investment in building out our screening sales infrastructure, advancing Shield HCP and DTC marketing programs and supporting ongoing oncology revenue growth.
第一季非 GAAP 營業費用為 2.68 億美元,成長 34%,主要由商業投資所驅動。雖然研發(R&D)與一般及行政(G&A)年對年僅小幅增加,但銷售與行銷費用在 2026 年第一季上升至 1.54 億美元,去年同期為 9,400 萬美元。這反映我們持續投資於建立篩檢銷售基礎設施、推進 Shield 的 HCP 與 DTC 行銷計畫,以及支持腫瘤收入的持續成長。
Adjusted EBITDA loss in Q1 was $59 million compared to a loss of $59 million in the first quarter of 2025. Free cash flow burn in Q1 2026 was $71 million compared to $67 million in the prior year period. The year over year change reflects an increase in the company-wide annual bonus payout in Q1 2026 compared to Q1 2025. Excluding this impact, free cash flow burn decreased by approximately $12 million year over year.
第一季調整後 EBITDA 虧損為 5,900 萬美元,與 2025 年第一季的 5,900 萬美元虧損相同。2026 年第一季自由現金流消耗(burn)為 7,100 萬美元,去年同期為 6,700 萬美元。年對年變動反映 2026 年第一季公司整體年度獎金發放金額較 2025 年第一季增加。若排除此影響,自由現金流消耗年對年約減少 1,200 萬美元。
We remain focused on disciplined cash management and are on track to decrease full year 2026 free cash flow burn compared to 2025. We ended the quarter with approximately $1.2 billion in cash and investments.
我們仍專注於嚴謹的現金管理,並按計畫在 2026 全年將自由現金流消耗較 2025 年降低。本季結束時,我們持有約 12 億美元的現金與投資。
Turning to slide 21. Over the past year, screening non-GAAP gross margin improved from 18% in Q1 2025 to 56% in Q1 2026. This improvement has been driven by an increase in Shield ASP, as I outlined earlier, and a decrease in Shield non-GAAP cost per test from $520 in Q1 2025 to $420 in Q1 2026, which is a result of higher volumes, disciplined cost management and efficient lab operations. As a reminder, we continue to expect Shield cost per test to decline to approximately $200 at scale, driven by further volume growth as well as workflow efficiencies and automation, which we expect to implement in 2027.
接著看第 21 張投影片。過去一年,篩檢業務的非 GAAP 毛利率由 2025 年第一季的 18% 提升至 2026 年第一季的 56%。此改善由 Shield ASP 的提升(如我先前所述)以及 Shield 非 GAAP 單次檢測成本由 2025 年第一季的 520 美元降至 2026 年第一季的 420 美元所驅動,這是更高的檢測量、嚴謹的成本管理與高效率實驗室營運的結果。提醒一下,我們仍預期在規模化後,Shield 的單次檢測成本將下降至約 200 美元,主要由進一步的檢測量成長,以及我們預計於 2027 年導入的流程效率提升與自動化所帶動。
Turning to slide 22. Based on our strong first quarter performance and increased visibility, we are raising our full year 2026 revenue guidance to a range of $1.30 billion to $1.32 billion, representing growth of 32% to 34%. Oncology revenue is now expected to grow 28% to 29% with volume growth of greater than 35%. Demand fundamentals remain strong across the portfolio. Guardant360 Liquid should continue to benefit from smart app adoption, while Guardant360 Tissue is building on recent upgrades and strong commercial execution.
接著看第 22 張投影片。基於我們第一季的強勁表現與能見度提升,我們將 2026 全年營收指引上調至 13.0 億至 13.2 億美元區間,代表成長 32% 至 34%。腫瘤營收目前預期成長 28% 至 29%,檢測量成長將超過 35%。整體產品組合的需求基本面仍然強勁。Guardant360 Liquid 應可持續受益於 Smart App 的採用,而 Guardant360 Tissue 則在近期升級與強勁的商業執行基礎上持續推進。
Reveal is expected to remain our fastest-growing oncology product, driven by MRD and therapy monitoring. Our oncology guidance does not include potential upside from FDA approval of Guardant360 Liquid or the launch of Reveal Ultra. We continue to expect biopharma and data to grow in the low double-digit range, supported by recent strategic partnerships, continued progress in our CDx pipeline and a combination of ongoing collaborations and new program starts.
預期 Reveal 將持續成為我們成長最快的腫瘤產品,主要由 MRD 與治療監測所帶動。我們的腫瘤業務指引未納入 Guardant360 Liquid 取得 FDA 核准或推出 Reveal Ultra 可能帶來的上行空間。我們仍預期生物製藥與資料業務將以低雙位數區間成長,並受近期策略性合作夥伴關係、CDx 產品線持續進展,以及既有合作延續與新專案啟動的組合所支撐。
Given the momentum exiting Q1, the impact we're seeing from our DTC and HCP campaigns and the launch of our Quest collaboration, we now expect screening revenue of $186 million to $198 million, driven by Shield volume of approximately 230,000 to 245,000 tests. Note that this improved outlook does not include upside from ACS guideline inclusion, which we continue to expect in the near term.
鑑於第一季結束時的動能、我們在 DTC 與 HCP 行銷活動所看到的影響,以及我們與 Quest 合作的啟動,我們現在預期篩檢營收為 1.86 億至 1.98 億美元,主要由 Shield 檢測量約 23 萬至 24.5 萬次所帶動。請注意,這項改善後的展望未包含納入 ACS 指引所帶來的上行空間,而我們仍預期在近期可望納入。
We continue to expect full year non-GAAP gross margin in the range of 64% to 65%, which reflects ongoing improvements to Guardant360 Liquid and Shield cost per test, balanced with changes to product mix as Shield and Reveal test volumes scale rapidly. Given the strength and momentum we're seeing with Shield, we plan to continue reinvesting incremental screening gross profit to support commercial expansion during the year.
我們仍預期全年 non-GAAP 毛利率介於 64% 至 65%,反映 Guardant360 Liquid 與 Shield 單次檢測成本的持續改善,同時也考量到隨著 Shield 與 Reveal 檢測量快速擴張而帶來的產品組合變化。鑑於我們在 Shield 所看到的強勁表現與動能,我們計畫在今年持續將新增的篩檢毛利再投資,以支持商業擴張。
Accordingly, we now expect 2026 non-GAAP operating expenses to be in the range of $1.05 billion to $1.07 billion, representing growth of 16% to 18% compared to 2025. We continue to expect full year free cash flow burn to be in the range of $185 million to $195 million, representing an improvement year over year. Excluding screening, we expect the remainder of the business to be free cash flow positive for the full year 2026, and we remain committed to achieving company-wide cash flow breakeven by the end of 2027.
因此,我們現在預期 2026 年 non-GAAP 營業費用介於 10.5 億至 10.7 億美元,較 2025 年成長 16% 至 18%。我們仍預期全年自由現金流消耗介於 1.85 億至 1.95 億美元,較去年同期有所改善。若排除篩檢業務,我們預期 2026 年其餘業務全年將為自由現金流正值,並且我們仍致力於在 2027 年底前達成全公司現金流損益兩平。
Turning to slide 23. We are executing well against our key 2026 priorities. In Oncology, we will complete the Guardant360 Liquid NovaSeq X transition this month and expect multiple product launches, including Reveal Ultra, FDA-approved Guardant360 Liquid and continued expansion of the Smart platform. Guardant360 Liquid ESR1 monitoring launch is dependent on FDA approval of camizestrant.
接著看第 23 張投影片。我們正針對 2026 年的關鍵優先事項執行得很到位。在腫瘤領域,我們將於本月完成 Guardant360 Liquid 向 NovaSeq X 的轉換,並預期有多項產品推出,包括 Reveal Ultra、取得 FDA 核准的 Guardant360 Liquid,以及 Smart 平台的持續擴展。Guardant360 Liquid ESR1 監測的上市將取決於 camizestrant 是否獲得 FDA 核准。
Last week, the Oncologic Drugs Advisory Committee voted 6 to 3 against the claim that camizestrant demonstrated clinically meaningful benefit in HR-positive HER2-negative metastatic breast cancer. Ultimately, the FDA retains full discretion over its final decision, and we look forward to that outcome in the coming months. Importantly, the committee's discussion reinforced the broader consensus that ctDNA companion diagnostic therapy monitoring represents the future of precision oncology care.
上週,腫瘤藥物諮詢委員會以 6 比 3 投票反對「camizestrant 在 HR 陽性、HER2 陰性的轉移性乳癌中展現具臨床意義的效益」這項主張。最終,FDA 對其最終決定保有完全裁量權,我們也期待在未來幾個月看到結果。重要的是,委員會的討論強化了更廣泛的共識:ctDNA 伴隨診斷的治療監測代表精準腫瘤照護的未來。
Furthermore, our revenue guidance does not reflect any impact from the potential approval of camizestrant. If it does receive FDA approval, this could represent a meaningful source of upside to Guardant360. In biopharma and data, we're advancing CDx programs and expanding strategic partnerships, including recent additions with leading biopharma companies and continue to scale our Infinity AI platform.
此外,我們的營收指引未反映 camizestrant 可能獲批所帶來的任何影響。若其確實獲得 FDA 核准,這可能成為 Guardant360 一項具意義的上行來源。在生物製藥與資料方面,我們正推進 CDx 專案並擴大策略性合作夥伴關係,包括近期與領先生物製藥公司新增合作,同時持續擴大我們的 Infinity AI 平台。
In Screening, we've launched our Quest collaboration and expanded Shield into multi-cancer detection markets in Asia through our partnership with Manulife. Overall, the business is delivering very strong growth, and we remain focused on disciplined execution as we scale.
在篩檢方面,我們已啟動與 Quest 的合作,並透過與 Manulife 的合作夥伴關係,將 Shield 擴展至亞洲的多癌種偵測市場。整體而言,業務正展現非常強勁的成長,我們在擴張規模的同時仍專注於紀律性的執行。
With that, we'll now open the call for questions.
接下來,我們將開放提問。
Operator
Operator
(Operator Instructions) Mark Massaro, BTIG.
(接線員指示) Mark Massaro,BTIG。
Mark Massaro - Equity Analyst
Mark Massaro - Equity Analyst
Congrats on the strong beat and raise. I'll stick with the Shield question. So it's nice to see both volumes and revenue come in above my expectations. And you talked about volumes accelerated momentum in March. I was curious if you could just speak to your confidence around April.
恭喜你們大幅超預期並上調展望。我會繼續問 Shield 的問題。很高興看到檢測量與營收都高於我的預期。你們也提到 3 月檢測量動能加速。我想請你們談談對 4 月的信心如何。
I would assume that, that is tracking well since you raised the guide. And can you just give us a sense for why you raised the volume guide up for Shield? If I remember this correctly, I believe the prior outlook excluded benefit from Quest. So how much of this might be adding Quest into the calculus versus any other drivers that you're seeing?
我猜測既然你們上調指引,應該追蹤得不錯。另外,你們能否說明一下為何上調 Shield 的檢測量指引?如果我沒記錯,先前的展望是不包含 Quest 帶來的效益。所以這次上調有多少是把 Quest 納入考量,還是來自你們看到的其他驅動因素?
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Thank you, Mark. Yes, we are very proud of what we did in Q1 in terms of Shield volume. January and February went as we expected. But as we entered March, really we saw such a huge momentum that was way better than actually what we expected. The root cause of it, like multiple things worked all at the same time hand to hand.
謝謝你,Mark。是的,我們對第一季在 Shield 檢測量方面的表現感到非常自豪。1 月與 2 月如我們預期。但進入 3 月時,我們確實看到非常強勁的動能,遠優於我們原先的預期。其根本原因是多項因素同時發揮作用、相互配合。
We talked about launching our DTC campaign, influencer campaigns, Quest went live at the same time, that EMR connectivity actually helped in a very meaningful way. And we saw that actually continue. So based on the trends that we've seen in March, and it's -- we don't want to get into Q2 commentary, but based on everything that we've seen, gives us a lot of good confidence of what we can deliver in this year.
我們談到啟動 DTC 行銷活動、網紅行銷活動,Quest 也在同一時間上線,而 EMR 連結也以非常有意義的方式提供了助力。而我們看到這樣的趨勢持續延續。因此,基於我們在 3 月看到的趨勢——我們不想對第二季做太多評論——但就我們所見的一切而言,讓我們對今年能交付的成果有很高的信心。
And still, we don't want to get ahead of our skis and be too excited with maybe what we've seen. But we are very confident of this new guide that we put out there.
同時,我們也不想操之過急,因為看到一些現象就過度興奮。但我們對這次提出的新指引非常有信心。
In terms of Quest contribution, we need to capture more data on how much really Quest is helping us incrementally. What we are seeing in terms of early indications are positive. So we are counting on some of that in our new guide, but again, in a very thoughtful way, and we are going to monitor how it goes in the months to come, and we've set the expectation accordingly.
至於 Quest 的貢獻,我們需要蒐集更多資料,才能了解 Quest 實際為我們帶來多少增量幫助。我們目前看到的早期跡象是正面的。因此,我們在新的指引中確實納入了其中一部分,但同樣是以非常審慎的方式;我們會在接下來幾個月持續觀察進展,並據此設定預期。
Operator
Operator
Subbu Nambi, Guggenheim.
Subbu Nambi,Guggenheim。
Subbu Nambi - Equity Analyst
Subbu Nambi - Equity Analyst
Congratulations on the print. Helmy, G360, despite being on the market for over a decade, is growing 30% year over year. While you have previously said there is no one reason for this outsized growth, could you give us additional color on what is driving this? Is it CRC now starting to adopt liquid? Is it repeat testing or something else? And then as we look to full year guidance, how much of the guide raise is attributed to G360 outlook?
恭喜這次的成績。Helmy,G360 儘管已上市超過十年,仍年增 30%。雖然你們先前表示這種超常成長並非由單一原因所致,但能否提供更多細節說明其驅動因素?是否是 CRC 現在開始採用液體檢測?是重複檢測,或是其他因素?另外,就全年指引來看,上調幅度中有多少可歸因於 G360 的展望?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Sure. Thanks for the question. Yes, we're very pleased with how, as you said, in its 10th year, Guardant360 continues to grow very nicely. I think a lot of it -- I think when we launched the smart liquid biopsy platform a few years ago, I think a lot of people sort of brushed it off as just a sort of marginal addition to the liquid biopsy space. But this is a fundamental step change in terms of the power of liquid biopsy and its capabilities, allowing us to see phenotype, allowing us to have all these different capabilities that were never possible with liquid biopsy before. And I think you're seeing us lean into that, and you're seeing the adoption begin to grow and grow.
當然。謝謝你的提問。是的,我們對 Guardant360 在第 10 年仍能如你所說持續非常漂亮地成長感到很高興。我認為其中很大一部分——幾年前我們推出 Smart 液體切片平台時,很多人有點把它當作只是對液體切片領域的邊際增量。但這其實是在液體切片能力與威力上的根本性躍升,使我們能看到表型,並具備許多過去液體切片無法做到的不同能力。我想你們正看到我們加大投入,而採用率也開始持續成長、愈來愈高。
So I think it's -- when we dig in and we peel down another layer, there's certainly, I would say, in this inning, a lot of share gains that are happening. There is greater depth and greater breadth as well in terms of physicians that haven't traditionally used liquid biopsy for certain tumor types. But I think all in all, the growth is very broad-based. And I think what's even more exciting is that we're still very much in the early innings of the platform's capabilities in terms of what we can do on the smart app side as well as the longitudinal testing. I mean we're still not testing at every progression, still very underpenetrated.
所以我認為——當我們深入探討、再剝開一層時,確實可以說,在這個階段,有大量的市占率提升正在發生。在以往未必會針對某些腫瘤類型使用液體活檢的醫師族群中,我們也看到更深的滲透與更廣的覆蓋。但整體而言,成長是非常廣泛、由多面向驅動的。而更令人振奮的是,就平台能力而言,無論是在智慧應用(smart app)端,或是縱向(longitudinal)檢測方面,我們仍然處於非常早期的階段。也就是說,我們仍未在每一次疾病進展時都進行檢測,滲透率仍然非常低。
And so that's the exciting part is that we're very confident that the growth continue not only in the short term, but the medium to long term as well.
因此令人興奮的是,我們非常有信心,這樣的成長不僅會在短期持續,也會在中期到長期持續。
Operator
Operator
Patrick Donnelly, Citi.
Patrick Donnelly,花旗(Citi)。
Patrick Donnelly - Analyst
Patrick Donnelly - Analyst
Helmy, maybe one for you on the Reveal side. I think you talked about over 100% growth there. Can you just talk about what you're seeing in the market, the key drivers there? And then I know you mentioned you submitted a few data packages to MolDx on breast cancer surveillance, some of the monitoring pieces. Maybe just talk about the catalyst set on that front on the reimbursement side, what we should be looking for on the Reveal front.
Helmy,想請教你一題關於 Reveal 這一塊。我記得你提到那邊的成長超過 100%。你能談談你在市場上看到的情況,以及主要驅動因素是什麼嗎?另外我知道你提到已向 MolDx 提交了幾份關於乳癌監測(surveillance)以及部分監測(monitoring)項目的資料包。也請談談在報銷(reimbursement)面向,這一塊有哪些催化劑(catalyst),我們在 Reveal 方面應該關注什麼。
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yes. We're very excited with how fast Reveal is growing, how much depth we're seeing there. Part of the drivers are we're still continuing to see really good growth in CRC, breast and lung cancers and the surveillance setting. But therapy monitoring has also been a great addition to the portfolio, and we're seeing, I think, great traction there. I think what that shows is really the brands that we've built over the last 12 years in oncology.
是的。我們對 Reveal 的成長速度以及我們在那裡看到的深度感到非常振奮。部分驅動因素是:我們在大腸直腸癌(CRC)、乳癌與肺癌的監測情境中,仍持續看到非常好的成長。同時,治療監測(therapy monitoring)也成為產品組合中很好的新增項目,我們看到我認為相當不錯的市場牽引力。我認為這也顯示出我們過去 12 年在腫瘤領域所建立的品牌力。
And when we launch something new, we tend to see, I think, ours is traction maybe versus, let's say, a new competitor in the market.
當我們推出新產品時,相較於例如市場上的新競爭者,我們往往能更快看到牽引力。
And then we're making progress with our multi submissions. I think the nice thing is the volume is sort of leading indicator. You can't generate revenue without the volume. And hopefully, when we get over the finish line with some of the submissions, they will really be in a good spot from a revenue and sort of overall ASP for the MRD business that we have.
另外,我們在多項提交(multi submissions)方面也在取得進展。我認為好的一點是,檢測量(volume)某種程度上是領先指標。沒有檢測量就無法產生營收。也希望當我們在部分提交案上跨過終點線時,能讓我們的 MRD 業務在營收以及整體 ASP(平均售價)方面都處於非常好的位置。
Operator
Operator
Doug Schenkel, Wolfe Research.
Doug Schenkel,Wolfe Research。
Unidentified Participant
Unidentified Participant
This is [Colleen] on for Doug. We've got a question on Shield ASP expectations. So it looks like ASP is holding up a little bit better than we had expected. And if we're doing the math right, it looks like you're expecting full year '26 Shield ASPs a bit north of $200 per test. If you -- if possible, could you share what percentage of Shield volume came from CMS in the quarter and how you expect that to evolve over the year?
我是代 Doug 提問的 [Colleen]。我們有一題關於 Shield ASP 預期的問題。看起來 ASP 的表現比我們原先預期的更能維持。如果我們計算無誤,看起來你們預期 2026 全年 Shield 的 ASP 每次檢測會略高於 200 美元。如果可以的話,你們能分享本季 Shield 檢測量中有多少比例來自 CMS,以及你們預期這個比例在今年會如何演變嗎?
Michael Bellisario - Analyst
Michael Bellisario - Analyst
Yes, I can take that. Q1 was pretty consistent with what we saw towards the back end of last year with a pretty high proportion of Shield tests being either Medicare fee-for-service or Medicare Advantage. And so that's what's been driving that strong ASP over the last few quarters. As we look out for the remainder of the year, we're expecting to sort of broaden the reach to patients under 65. And of course, we're not covered yet on the commercial side.
好的,我來回答。第一季的情況與去年年底相當一致:Shield 檢測中有相當高的比例來自 Medicare 按服務計費(fee-for-service)或 Medicare Advantage。因此,這也是過去幾季推動 ASP 強勁的主要原因。展望今年剩餘時間,我們預期會把觸及範圍擴大到 65 歲以下的病患。當然,目前在商業保險(commercial)端我們還沒有獲得給付覆蓋。
And so I think our sort of expectation and our guide sort of implies a tick down in the ASP for the remainder of the year as we build out that commercial patient volume and getting ahead of when we start to get the reimbursement.
因此,我們的預期以及指引(guide)其實隱含:隨著我們擴大商業保險病患的檢測量,並在開始取得報銷之前先行布局,今年剩餘時間的 ASP 會小幅下滑。
So yes, today, it's been strong. It's predominantly Medicare, Medicare Advantage, but that sort of mix is going to skew a little bit more to the other 65 throughout the year.
所以是的,目前表現很強。主要是 Medicare、Medicare Advantage,但隨著全年推進,這個組合會稍微更多偏向 65 歲以下的族群。
Operator
Operator
Casey Woodring, JPMorgan.
Casey Woodring,摩根大通(JPMorgan)。
Sebastian Sandler - Analyst
Sebastian Sandler - Analyst
This is Sebastian Sandler on for Casey. Can you dig a little more into the G360 Tissue growth you're seeing? You're growing well above the market. So it seems like you're taking some share there. I'm just curious how sustainable maybe some of these share gains are?
我是代 Casey 提問的 Sebastian Sandler。你能再多談一些你們看到的 G360 Tissue 成長嗎?你們的成長明顯高於市場。所以看起來你們正在取得一些市占。我想了解的是,這些市占提升在可持續性方面如何?
And then can you talk about the pathway to ASP upside from this whole transcriptome addition? I would expect that would be more than the $300 benefit you saw from the initial RNA element.
另外,你能談談加入完整轉錄體(transcriptome)後,ASP 上行的路徑嗎?我會預期那會高於你們在最初 RNA 元件帶來的 300 美元增益。
Michael Bellisario - Analyst
Michael Bellisario - Analyst
Yes. Great question. Yes, obviously, we're very pleased with the growth we're seeing in tissue. And we think one of the things that will sort of further accelerate that growth is as we get FDA approval for our Guardant360 Liquid test. And we think that will really streamline the portfolio, allow simplified ordering between the 2 products and really help move everything on to the Smart Platform.
是的。好問題。很明顯地,我們對組織(tissue)端看到的成長非常滿意。我們認為能進一步加速這個成長的因素之一,是當我們的 Guardant360 Liquid 檢測取得 FDA 核准之後。我們認為那將真正簡化產品組合,讓兩個產品之間的下單更簡便,並且真正幫助把所有內容推進到 Smart Platform 上。
And so yes, we believe this growth is sustainable. But right now, sort of the trajectory is being led by Guardant360 Liquid in terms of just how advanced those capabilities are. But the nice thing is that 360 Tissue will also have a lot of the same smart apps over time. And so we think essentially tissue can just graph behind really, I think, amazing growth we're seeing with our liquid portfolio.
因此,是的,我們相信這樣的成長是可持續的。但目前整體成長軌跡主要仍由 Guardant360 Liquid 帶動,因為它的能力成熟度更高。不過好的一點是,隨著時間推進,360 Tissue 也會具備許多相同的智慧應用(smart apps)。因此我們認為,組織端基本上可以沿著我們液體產品組合所呈現的、我認為非常亮眼的成長曲線一路跟上。
In terms of old transcriptome, maybe if we take a step back, I think the overall sort of trajectory or pathway we're seeing with 360 Tissue is that obviously, that will go through its own regulatory pathway. We'll submit that to the FDA at some point. And we believe we can qualify for essentially ADLT status there as well, which should improve ASP further substantially.
至於完整轉錄體(transcriptome),也許我們先退一步看:我們在 360 Tissue 上看到的整體軌跡或路徑是,顯然它會走自己的法規(regulatory)路徑。我們會在某個時間點把它提交給 FDA。而我們相信在那裡也能符合 ADLT 身分(Advanced Diagnostic Laboratory Test)的資格,這應該能進一步大幅提升 ASP。
Operator
Operator
Puneet Souda, Leerink Partners.
Puneet Souda,Leerink Partners。
Puneet Souda - Analyst
Puneet Souda - Analyst
First one on Shield, 90% adherence rate, that is impressive, something AmirAli, you've been pointing out for some time, just as you were pointing out, FDA approval of Shield and both of those obviously coming to fruition here. So I really like the consistency and insight here. But could you talk about the Shield volume cadence through the year? How should we think about the next 3 quarters, just given the momentum you're seeing and the effort around the ads and the marketing and all of that DTC that you're putting behind Shield?
第一題關於 Shield,90% 的依從率(adherence rate)很令人印象深刻;AmirAli,你一段時間以來一直在強調這點,而你也提到 Shield 的 FDA 核准——這兩件事現在都在這裡實現了。所以我很喜歡這裡呈現出的連貫性與洞見。不過你能談談 Shield 在全年各季的量能節奏(volume cadence)嗎?考量你們看到的動能,以及你們在廣告、行銷與所有面向消費者(DTC)的投入,接下來三個季度我們應該如何看待?
And on the oncology side, help me G360 repeat use is an important driver. Cami AdCom was resoundingly positive for G360 and ctDNA use. But the problem was the trial design, not the assay. Going forward, how should we think about the repeat use from 1.3 average? How does that go higher in the future?
另外在腫瘤端,幫我理解一下:G360 的重複使用(repeat use)是一個重要驅動因素。Cami AdCom 對 G360 與 ctDNA 的使用給出了壓倒性正面的意見。但問題在於試驗設計,而不是檢測(assay)。往前看,我們應該如何看待從目前平均 1.3 次的重複使用?未來要如何提高?
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Thank you, Puneet. So our guide for this year now for Shield, when you do the calculation, it kind of implies an average of about maybe a little bit over 10,000 sequential growth like Q-over-Q. And as I mentioned earlier, we feel very confident about this new guidance. And we'll see how it goes. Again, we didn't want to get ahead of our skis.
謝謝你,Puneet。所以我們今年對 Shield 的指引,當你做計算時,它某種程度上意味著平均大約、可能略高於 10,000 的連續成長,也就是按季(Q-over-Q)。而且如我先前提到的,我們對這個新的指引非常有信心。我們會看看進展如何。再次強調,我們不想操之過急。
We want to capture more data of how our DTC campaigns are going to continue to impact our volume, how Quest is going to contribute, how much more we can see the rep productivity is going to go up. We continue to hire reps. We have that element, too. But currently, this new guide, I think, is the right guide that we feel very confident of a little bit over 10,000 Q-over-Q growth.
我們希望蒐集更多數據,了解我們的 DTC 行銷活動將如何持續影響我們的量、Quest 將如何貢獻、以及我們能看到業務代表生產力提升多少。我們也持續招募業務代表。這也是其中一個因素。但就目前而言,這個新的指引,我認為是正確的指引;我們對略高於 10,000 的按季成長非常有信心。
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
In terms of the 1.3 average that you mentioned on 360, I think -- what we see is that there are multiple shots on goal to getting, I think, this feature that everyone believes in, which is going from biopsies and scans to just using the power of smart liquid biopsy and blood to monitor patients adaptively and dynamically. And so there are multiple shots on goal there. And I think the primary one is going to be using really the 1, 2 punch of Guardant360 liquid and Reveal for monitoring. And then as Reveal ebbs and flows, it will be a much simpler way to reflex patients to essentially a 360 test in those patients if and when those patients progress.
關於你提到 360 的 1.3 平均值,我想——我們看到的是,為了實現大家都相信的這個特性,有多個「達成目標的機會」,也就是從活檢與掃描,轉向僅使用智慧液體活檢與血液的力量,以適應性、動態方式監測病患。因此在那裡有多個達成目標的機會。我認為主要的方式會是,真正運用 Guardant360 liquid 與 Reveal 的「1、2 連擊」來進行監測。接著,當 Reveal 的使用量起伏變動時,若這些病患在某個時間點出現進展,將病患反射(reflex)到 360 檢測,本質上會是一個更簡單的方法。
And so we think this feature will happen. It's starting to happen now with the launch of Reveal for therapy monitoring, which we're seeing exciting traction for. And we're very confident that regardless of how camizestrant turns out, the future of oncology and the future of therapy switching will involve ctDNA.
因此我們認為這個特性會發生。它現在已經開始發生,因為我們推出了用於治療監測的 Reveal,我們看到令人振奮的牽引力。而且我們非常有信心,不論 camizestrant 最終結果如何,腫瘤學的未來以及治療切換的未來都將涉及 ctDNA。
Operator
Operator
Dan Arias, Stifel.
Dan Arias,Stifel。
Daniel Arias - Analyst
Daniel Arias - Analyst
Helmy, on that point, on the camizestrant AdCom, some of the folks on the committee seem to suggest that the vote for them would have been a yes if there was an overall survival benefit. From where you sit, are the trials that might be on deck here set up endpoint-wise to show that? What do we have coming to us in terms of evidence generation and getting over the hump there on what these folks might need to see?
Helmy,針對 camizestrant 的 AdCom,有些委員似乎表示,如果有整體存活期(overall survival)的獲益,他們就會投下贊成票。以你目前的角度來看,接下來可能要進行的試驗,在終點設計上是否有能力呈現那樣的結果?就證據產出而言,我們接下來會看到什麼,才能跨過門檻、滿足這些人可能需要看到的內容?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yes. I mean, obviously, we don't want to comment on the specifics of any one trial. But yes, we're very confident that over time, there are other trials that I think are going to sort of push the envelope. It's always hard for the first paradigm shift. And there's always a mountain of evidence that's required from moving from one paradigm from one modality to another one.
是的。我的意思是,顯然我們不想評論任何單一試驗的具體細節。但沒錯,我們非常有信心,隨著時間推進,還有其他試驗我認為會在某種程度上推進界線。第一次的典範轉移總是最困難的。而且從一種典範、從一種模式轉向另一種模式,總是需要大量的證據。
But once that dam is broken, it's very hard to go back to the previous paradigm. And so it's just a matter of when, not if, and we're very confident we'll get there over the next few years, if not sooner.
但一旦那道堤壩被打破,就很難再回到先前的典範。所以只是時間早晚的問題,而不是會不會發生;我們非常有信心在未來幾年內、甚至更早就能達成。
Operator
Operator
Kyle Mikson, Canaccord.
Kyle Mikson,Canaccord。
Kyle Mikson - Equity Analyst
Kyle Mikson - Equity Analyst
Congrats on the quarter. Mike, on the ASP for Shield, and this was touched on earlier, but it looks like the rest of the year ASP implied in the guide, the new guide is like high 500s. I'm just curious what you're assuming in terms of mix and why would it be that low? That's quite obviously. And then secondly, on -- maybe just a broader question, perhaps help me can answer this.
恭喜本季表現。Mike,關於 Shield 的 ASP(平均售價),這點先前有提到,但看起來在指引中、今年剩餘期間所隱含的 ASP,大概是 500 多美元的高段。我只是好奇你對產品組合(mix)的假設是什麼,為什麼會那麼低?這很明顯。然後第二個——也許是更廣泛的問題,或許 Helmy 可以回答。
So we have this acquisition today of an AI-based kind of diagnostics company. Is this -- I mean I know it's like one example, but are you guys thinking about ways to kind of step up your AI game and offer AI-based companion diagnostics or anything of that sort?
所以我們今天收購了一家以 AI 為基礎的診斷公司。這——我的意思是我知道這只是其中一個例子,但你們是否在思考一些方式來提升你們的 AI 佈局,並提供以 AI 為基礎的伴隨式診斷(companion diagnostics)或類似的產品?
Michael Bellisario - Analyst
Michael Bellisario - Analyst
Yes, Kyle, I'll take the Shield ASP question first. Now actually, if you look at our guide on the volume increase and the revenue increase, what it implies is for Q2 through Q4, on average, the ASP is around $775, which is effectively the same sort of guide that we gave for that part of the year back in February. So there's no change. And yes, as I mentioned before, what's driving that tick down from Q1, which is very strong, is going to be just the mix of Medicare, Medicare Advantage versus commercial patients where we're not getting paid now.
是的,Kyle,我先回答 Shield 的 ASP 問題。其實,如果你看我們對量的增加與營收增加的指引,它所隱含的是,從第二季到第四季,平均 ASP 約為 775 美元,這基本上與我們在二月對該年度後段所給的指引相同。所以沒有變化。而且如我先前提到的,造成第一季(非常強勁)之後 ASP 略微下滑的原因,將只是 Medicare、Medicare Advantage 相對於商業保險病患的組合變化;對於商業保險病患,我們目前尚未收到付款。
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yes. In terms of the AI question, I feel like we've been leading the pack, frankly, in terms of real AI that has that actionable insight. There's a lot of talk about AI in the space, but I think you can see physicians voting with their feet when they're using our products much more than others in the space right now. And we were one of the -- we are the first to bring AI pathology to the oncology space with the Lumen collaboration we did a few years ago. You're seeing what we're doing with Infinity AI.
是的。至於 AI 的問題,我覺得坦白說,我們一直是領先者,尤其是在能提供可採取行動洞見(actionable insight)的真正 AI 方面。這個領域有很多關於 AI 的討論,但我認為你可以看到醫師用腳投票:他們現在使用我們的產品遠多於同業其他產品。而且我們是——我們是第一個把 AI 病理帶進腫瘤領域的公司,這是我們幾年前與 Lumen 的合作。你也看到我們在 Infinity AI 上所做的事情。
I think we'll be one of the first to amass an exabyte of data. And data is really the raw fuel that's required to use AI to have truly actionable insights.
我認為我們會是第一批累積到 1 exabyte 資料量的公司之一。而資料正是使用 AI 以產生真正可採取行動洞見所需的原始燃料。
And so we built an architecture that's purpose-built from the ground up to be really deployed and utilized and worked with AI in, I think, very fruitful way. And yes, you're going to see, I would say, over the coming quarters, us really sharing a lot more in terms of all the exciting things that we're building with AI and with the enormous treasury of data that we have inside the company.
因此我們從零開始打造了一個為此目的量身設計的架構,能夠被部署、被使用,並以我認為非常有成果的方式與 AI 協作。而且是的,我想你會在接下來幾個季度看到我們分享更多內容,關於我們用 AI 以及公司內部龐大的資料寶庫正在打造的各種令人振奮的事情。
Operator
Operator
Tycho Peterson, Jefferies.
Tycho Peterson,Jefferies。
Tycho Peterson - Analyst
Tycho Peterson - Analyst
A couple of quick ones. I guess you've had a couple on SERENA-6. Just a different angle, though. How does this change your time lines for establishing therapy monitoring as a standard billable event versus just therapy selection? Does this kind of extend the adoption curve and other lessons learned from this trial as we think about other high-volume areas like lung and CRC surveillance.
幾個快速問題。我想你們已經被問了幾個關於 SERENA-6 的問題。不過換個角度。這會如何改變你們把治療監測建立為一個可作為標準計費事件(standard billable event)的時間表,而不只是治療選擇?這是否會延長採用曲線?以及從這項試驗得到的其他經驗教訓,當我們思考其他高量領域,例如肺癌與 CRC 監測(surveillance)時,有哪些啟示?
So that's one question.
這是第一個問題。
Second is consolidation that came up in an earlier question. There's been a lot. How are you thinking about competitive landscape? I mean now you've got Roche with Saga. Obviously, [ Abbott ] with [ Exact ].
第二個是先前問題提到的整併。整併很多。你們如何看待競爭格局?我的意思是,現在你有 Roche 搭配 Saga。顯然,[ Abbott ] 搭配[ Exact ]。
Just curious if that changes your thoughts on size of sales channel, go-to-market strategy at all? And then for Mike, was there any weather impact? I've had a few people asking if there's going to be any catch-up in 2Q. Obviously, you grew through it, but was there any headwind from PCP visit cancellations?
只是好奇這是否會改變你們對銷售通路規模、上市策略(go-to-market strategy)的想法?另外問 Mike,有沒有任何天氣影響?我有幾個人問第二季是否會有任何補回(catch-up)。顯然你們在那段期間仍然成長,但 PCP(基層照護醫師)門診取消是否帶來任何逆風?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
In terms of the SERENA-6 question, our primary shots on goal there are frankly, the Reveal therapy monitoring we just launched and the reimbursement packages we have on deck in terms of IO therapy monitoring, chemotherapy monitoring, which are really the primary modalities and tools and the therapies in oncology therapy space right now. And so with those two over the finish line, I think we'll be in a very, very good spot from a therapy monitoring point of view. And as we said, things like SERENA-6 and specific trials are frankly, upside really to that primary pathway.
就 SERENA-6 的問題而言,我們主要的努力方向坦白說是我們剛推出的 Reveal 治療監測,以及我們已準備就緒、關於 IO 治療監測與化療監測的給付方案;而這些確實是目前腫瘤治療領域中最主要的治療模式、工具與療法。因此,當這兩項都推進到終點線之後,我認為從治療監測的角度來看,我們會處在非常、非常有利的位置。而且如同我們所說,像 SERENA-6 以及特定試驗,坦白說,對於那條主要路徑而言更多是上行空間。
In terms of consolidation, we look at almost, I think every company in the space always thinking about balancing organic growth with inorganic growth. But as you can see, the bar is very high in terms of what we built organically inside the company, the growth rates, the quality of our products and so on. And so it really has to be something that is accretive to what we built here. But yes, I think it will happen at some point.
就整併而言,我們幾乎會看——我想這個領域裡的每家公司都一樣——總是在思考如何在有機成長與非有機成長之間取得平衡。但如你所見,我們在公司內部有機打造的成果門檻非常高,包括成長率、產品品質等等。因此,真的必須是能對我們在這裡所建立的基礎帶來增益的項目。不過是的,我認為在某個時間點會發生。
Michael Bellisario - Analyst
Michael Bellisario - Analyst
Yes. And then with respect to the weather impact, I mean, in Q1, we saw the normal seasonal impact related to sort of PCP footfall as well as weather. That was expected. That was in our original guide. And so the start of the year came in, yes, again, as we expected.
是的。至於天氣影響,我的意思是,在第一季我們看到與 PCP(基層照護醫師)就診人流以及天氣相關的正常季節性影響。那是預期之內的。那也已經包含在我們原先的指引中。因此年初的表現,是的,再次地,符合我們的預期。
So no, we don't anticipate any catch-up. I think what we saw in the start of the year was just what we would normally expect to see every year.
所以不,我們不預期會有任何補回效應。我認為我們在年初看到的,就是我們每年通常會預期看到的情況。
Operator
Operator
Bill Bonello, Craig-Hallum.
Bill Bonello,Craig-Hallum。
Bill Bonello - Analyst
Bill Bonello - Analyst
I have maybe a slightly bigger picture question, but that's just sort of getting at the importance of the portfolio that you've built out. Just curious if you can give us some sense of the percentage of customers that are ordering multiple products, so say, 360 Liquid and Tissue and Reveal. And then maybe along with that, with this growth, how much of it is sort of competitive takeaway versus docs that might be using some of these products, let's say, de novo?
我可能有一個稍微更宏觀的問題,但主要是想了解你們所建立的產品組合的重要性。想請教你們能否提供一些資訊:有多少比例的客戶會同時訂購多項產品,例如 360 Liquid、Tissue 以及 Reveal。另外,伴隨這樣的成長,其中有多少是來自於從競爭對手那裡搶下市占,對比於醫師可能是首次(de novo)開始使用這些產品?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yes, it's a great question. Those are numbers that keep going up every single quarter in terms of the depth of ordering, not just the number of patients that the physician may have where they're ordering, let's say, a single product from us, but really the number of essentially linked products we have where there may be a CDx cluster tissue and then the physician may be sort of monitoring those patients or they may be using an MRD product from us for another patient subset.
是的,這是個很好的問題。就訂購深度而言,這些數字每一季都在上升;不只是醫師可能有多少病患、他們向我們訂購例如單一產品,而是我們本質上有多少「連動」的產品——例如可能有一個 CDx 的組織檢測群組,接著醫師可能會對那些病患進行監測,或是對另一個病患子群使用我們的 MRD 產品。
And that is really the power of the platform really this idea that all these products are all linked. And I think that is why having such a comprehensive portfolio is so important because essentially any one of those products with their best-in-class can help convert those users and those physicians to Guardant evangelist.
而這正是平台的力量,也就是這個概念:所有這些產品彼此都是連結的。我認為這也是為什麼擁有如此全面的產品組合非常重要,因為本質上,任何一個同級最佳的產品都能幫助我們轉化那些使用者與醫師,讓他們成為 Guardant 的擁護者。
And I would say that for the like de novo versus the sort of users, we have something like, I think, 10,000, 11,000 oncologists who order from us certainly on a quarterly kind of basis. And so it's very hard to sort of gain shares in terms of de novo physicians at this point. So it's mostly that. I would say it's a balance of greater depth in terms of percentage of patients that are sort of Guardant360 or Guardant products are being utilized and then certainly, share gains as well. And then I think the exciting part is, obviously, there's a longitudinal aspect that we're barely penetrated and which I think will lead to, I think, growth for the coming years --
至於 de novo 與既有使用者的部分,我會說我們大概有 10,000 到 11,000 位腫瘤科醫師,至少以季度的頻率向我們下單。因此,在這個時間點要在 de novo 醫師方面取得市占其實非常困難。所以主要是那一塊。我會說這是在更深的使用滲透(也就是 Guardant360 或 Guardant 產品被使用於病患的比例提高)與市占提升之間的平衡。而我認為令人興奮的是,顯然還有一個縱向(longitudinal)的面向我們幾乎尚未深入滲透,我認為這將帶來未來幾年的成長--
Operator
Operator
Michael Ryskin, Bank of America.
Michael Ryskin,美國銀行。
Michael Ryskin - Analyst
Michael Ryskin - Analyst
Congrats on the quarter again. Maybe sort of a big picture one. There's been a little bit of a land grab among some of your competitors on the market access in terms of expanding sales force building out as they launch new products and as they try to scale their existing products. Just curious what your internal plans are for commercial sales force, where you're expanding, where you're investing and just sort of across the portfolio, if you could walk us through the rest of the year, where you see some of that incremental OpEx going?
再次恭喜本季表現。我想問一個比較宏觀的問題。你們的一些競爭對手在市場准入方面有點像是在「圈地」,透過擴大銷售團隊、在推出新產品以及擴大既有產品規模時加速建置。想請教你們內部對商業銷售團隊的規劃是什麼:你們會在哪些地方擴張、在哪些地方投資?以及就整個產品組合而言,能否帶我們走一遍今年剩餘時間裡,你們預期那些新增的營運費用(OpEx)會投向哪裡?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
On the oncology side, this has been a matter, of course, now for a number of years where we look at revenue per territory per rep. And as long as there's no saturation in that territory, we may split it, we may add additional reps, additional support staff. And so that's just a matter of good hygiene for us, and we'll continue to do that where we see positive ROI. But I would say that I think we've prided ourselves on fairly high, maybe industry best sales efficiency. And so we will always try to do it in the most efficient way.
在腫瘤業務方面,這當然是我們多年來一直在做的事:我們會看每個區域、每位業務代表的單位營收。只要該區域尚未飽和,我們可能會拆分該區域、增加更多業務代表、增加更多支援人員。因此這對我們而言只是良好的基本管理衛生(good hygiene),我們會在看到正向投資報酬率(ROI)的地方持續這麼做。但我會說,我們一直以相當高、也許是業界最佳的銷售效率為傲。因此我們會一直嘗試以最有效率的方式來做。
But yes, we're not going to sort of skim on sales and marketing where there's positive ROI.
不過是的,只要有正向 ROI,我們不會在銷售與行銷上省略投入。
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
On the screening side, as we talked about it before, any additional gross profit in terms of year over year is getting reinvested in building the S&M function. They have a very good traction that goes into hiring additional sales force now is going towards this marketing campaigns like DTC campaign that we talked about earlier. It's kind of very interesting, in fact, I heard from our Head of Sales, we are continuing to hire this year, too, that even the quality of the reps that we are hiring continues to go up. So we are very excited with what we are seeing right now.
在篩檢業務方面,如同我們之前談過的,任何年度對年度增加的毛利都會再投資於建置銷售與行銷(S&M)職能。目前的動能非常好,因此除了持續招募更多銷售人力之外,也會投入到我們先前提到的行銷活動,例如 DTC(直接面向消費者)活動。其實很有意思,我從我們的銷售主管那裡聽到,我們今年也會持續招募,而且我們招募到的業務代表品質還在持續提升。所以我們對目前看到的狀況感到非常振奮。
Operator
Operator
Dan Brennan, TD Cowen.
Dan Brennan,TD Cowen。
Daniel Brennan - Analyst
Daniel Brennan - Analyst
Maybe one on G360 and just one on multi-cancer. So on G360, really nice quarter, 30% volume growth, well above expectations. I know there was a comment question or two earlier, but just can you speak to a little bit again like what was better than you thought to drive that kind of volume growth? And then b, kind of implicit within the new 35% oncology volume growth, how are you thinking about G360? And then just on multi-cancer, can you just remind us of the strategy there?
我想問一個關於 G360 的問題,再問一個關於多癌種的問題。先談 G360,本季表現很不錯,量的成長 30%,遠高於預期。我知道前面已經有一兩個相關的提問或評論,但你們能否再談談:有哪些地方比你們原先想的更好,從而帶動這樣的量成長?另外,隱含在新的 35% 腫瘤量成長之中,你們是如何看待 G360 的?最後關於多癌種,你們能否提醒我們那邊的策略是什麼?
When we'll learn more? You're obviously having the ability to have patients opt in. What's the timetable at which we will get some clarity on the regulatory plan there? I know you've been bullish about the number of samples you'll be collecting, but just wondering how we think about the path forward there.
我們何時會了解更多?你們顯然具備讓病患選擇加入(opt in)的能力。我們大概在什麼時間表上,能對那邊的法規(監管)計畫有更清楚的了解?我知道你們對將收集到的樣本數量一直很樂觀,但只是想了解我們該如何看待接下來的推進路徑。
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
In terms of G360, I don't think there was anything that kind of completely surprised us. I mean I think we know that the test is really best-in-class offers a lot of capabilities that, frankly, are not available in the market. And I think we're just continuing to lean into that. When we think about the rest of the year, I think beginning, we said something like 20% year over year growth for 360. That's obviously with a strong quarter inching up.
就 G360 而言,我不認為有任何事情是完全出乎我們意料的。我的意思是,我們知道這項檢測確實是同級最佳,提供了許多坦白說在市場上並不存在的能力。而我們只是持續加大在這方面的投入。當我們思考今年剩餘時間時,我想一開始我們提到 360 的年對年成長大約是 20%。在一個強勁季度的帶動下,這顯然正在往上靠近。
And we're going to continue pushing the Vision 360 out there. The FDA approval of 360 should be another major catalyst that hopefully will be even upside to this current --
我們將持續在市場上推動 Vision 360。360 的 FDA 核准應該會是另一個重大催化劑,期望能在目前的基礎上帶來更大的上行空間--
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
On the MCD front, this option rate is going strong. And with the strategy that we have, we are on track to have the biggest clinical database of MCD testing and the value on the patient from U.S. patient population in near future. So still, we have a couple of milestones to hit to build that database. So let us get there and then we would set the right expectation for the timing of the regulatory milestones.
在 MCD 方面,這個採用率持續強勁。而且依照我們的策略,我們正按計畫在不久的將來建立起最大的 MCD 檢測臨床資料庫,以及來自美國病患族群的病患價值資料。因此,我們仍有幾個里程碑需要達成以建置該資料庫。所以讓我們先達成那些目標,之後我們會就監管里程碑的時程設定正確的預期。
But we are pleased with what we are seeing today.
但我們對於目前所看到的進展感到滿意。
Operator
Operator
Brandon Couillard, Wells Fargo.
Brandon Couillard,富國銀行。
Brandon Couillard - Equity Analyst
Brandon Couillard - Equity Analyst
A couple on Shield. How many reps do you expect to have on board exiting the year at this point in the context of the higher revenue guide? Number two, do you expect only needing 2 blood tubes to be a volume driver? And number three, on ATF guidelines, why don't you think they've been published yet? Are you able to share any feedback from maybe some of your interactions with the organization?
有幾個關於 Shield 的問題。在較高的營收指引背景下,就目前而言,你們預期年底時會有多少名業務代表到位?第二,你們是否預期只需要 2 管血會成為帶動量能的因素?第三,關於 ATF 指引,你們為什麼認為它們至今尚未發布?你們是否能分享一些來自與該組織互動的回饋?
Amirali Talasaz - Co-Chief Executive Officer, Director
Amirali Talasaz - Co-Chief Executive Officer, Director
Yes. So we entered this year with like the 300 reps that we talked about. And as I mentioned, this incremental gross profit that we're going to have this year is going to get reinvested back. We are not planning to just give like pipe kind of updates on the size of the sales team as the field is becoming competitive, and that's commercially sensitive information. But based on this high-level guide, I think you guys are well positioned to have some estimation of how many people we are going to have by end of, let's say, 2026.
是的。我們在今年開始時,正如我們談到的,大約有 300 名業務代表。如我提到的,我們今年將新增的毛利會再投入回去。由於前線市場競爭日益激烈,我們不打算就銷售團隊規模提供類似「管線式」的更新,因為那屬於商業敏感資訊。但基於這個高層級指引,我認為各位應該能夠相當好地估算到例如 2026 年底時我們大概會有多少人。
In terms of two-tubes, on one side, we didn't hear any kind of issue with 4-tube, but we always want to have the best-in-class, easiest customer experience with Guardant products. As a result, we worked on studies to reduce the four-tubes even to two-tube, and we are very pleased that we got the approval from FDA, and we are going live with that updated kit in very near future.
就兩管血而言,一方面,我們沒有聽到任何關於四管血的問題,但我們始終希望 Guardant 產品能提供同級最佳、最容易的客戶體驗。因此,我們進行研究,將四管血減少到兩管血;我們很高興已獲得 FDA 核准,並將在不久的將來正式啟用這套更新後的採檢套組。
In terms of ACS guideline, I know you guys are hearing from me. It's coming. It's coming now probably for over a year. And my answer is the same. I think it's going to come any day, but I've been kind of a broken record on it. Our conversation with them continues to be actually pretty positive. and looks like everything is done. So we are just waiting for the finalized guidelines to be published. So it should be any day, but we'll see.
關於 ACS 指引,我知道各位一直聽我說。快了。現在這句話可能已經說了一年多。而我的回答仍然一樣。我認為它隨時都可能出來,但我在這件事上確實有點像壞掉的唱片。我們與他們的對話其實一直相當正面,而且看起來一切都已完成。所以我們只是在等待最終版指引發布。因此應該是隨時,但我們再看看。
Last question please.
請問最後一題。
Operator
Operator
Bradley Bowers, Mizuho.
Bradley Bowers,瑞穗。
Bradley Bowers - Analyst
Bradley Bowers - Analyst
Just wanted to maybe double-click on where you're kind of seeing the Reveal volume growth. The pricing doesn't lend itself to be in Medicare CRC, but maybe I'm wrong. But just based on KOL checks, that area may be preferring tissue. Just wanted to see where you're kind of seeing some of the volume growth ahead of expectation and maybe what the expectations for volume and price should be post breast.
我想再深入確認一下你們看到 Reveal 檢測量成長主要來自哪些地方。這個定價看起來不太適用於 Medicare 的 CRC,但也許我理解有誤。不過根據我們對 KOL 的訪查,那個領域可能更偏好組織檢體。想請教你們目前看到哪些地方的量能成長超出預期,以及在乳癌之後,對量與價格的預期應該是什麼?
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Helmy Eltoukhy - Chairperson of the Board, Co-Chief Executive Officer
Yes. I would say we're seeing growth, frankly, across the board. CRC, breast has been very strong for us, lung. And then obviously, new indication of therapy monitoring has been relatively strong for us as well. So yes, I think the market really has, I would say, sort of two parts to it.
是的。我會說我們確實看到各方面的成長。CRC、乳癌對我們一直非常強勁,肺癌也是。然後很明顯地,新的適應症——治療監測——對我們而言也相對強勁。所以是的,我認為市場大致可以分成兩個部分。
The consumer-informed sort of MRD subset and then certain market as well that is very, very sizable. Right now, we're the far and away leader in MRD, and we're continuing to lean into that. And obviously, we'll be excited when we dip our toes into more informed with Reveal coming later this year. I'll let maybe Mike talk about ASP.
一部分是「已知腫瘤資訊(informed)」的 MRD 子市場,另一部分則是同樣非常、非常龐大的特定市場。目前我們在 MRD 領域遙遙領先,並且會持續加大投入。而且當我們在今年稍晚以 Reveal 進一步涉足更多 informed 領域時,我們也會很期待。我讓 Mike 來談一下 ASP。
Michael Bellisario - Analyst
Michael Bellisario - Analyst
Yes. No, ASP continues to be in this range, $600 to $700. I think we're excited hopefully to get incremental MolDx coverage in the near future with the breast and IO and chemo submissions that we've made. So obviously, getting Medicare coverage for each of those is going to have a nice positive impact. So definitely, breast is a large portion of the volume now.
是的。沒有,ASP 仍維持在這個區間,也就是 600 到 700 美元。我們希望在不久的將來,透過我們已提交的乳癌、IO 與化療申請,能獲得額外的 MolDx 承保。因此,為每一項取得 Medicare 承保都會帶來不錯的正面影響。所以可以確定的是,乳癌目前已占了相當大一部分的量。
And so if we get that, it will definitely take us beyond the current range that we're in and sort of move us step-by-step closer to the $1,000 target that we set for 2028. So I think getting that coverage is going to be very positive for us.
因此如果我們拿到承保,將會把我們帶離目前的區間,並一步一步更接近我們為 2028 年設定的 1,000 美元目標。所以我認為取得該承保對我們會非常正面。
Operator
Operator
No additional questions waiting at this time. So I'll pass the call back to management for any closing remarks.
目前沒有其他問題在等待。我將把電話交回管理層,請他們做任何結語。
Michael Bellisario - Analyst
Michael Bellisario - Analyst
That's it. Thank you, Matt.
就這樣。謝謝你,Matt。
Operator
Operator
That concludes the conference call. Thank you for your participation. You may now disconnect your lines.
本次電話會議到此結束。感謝各位的參與。您現在可以掛斷電話線。