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Operator
Operator
Thank you for standing by. My name is Jeannie and I will be your conference operator today. At this time, I would like to welcome everyone to the Exact Sciences second-quarter 2025 earnings call. (Operator Instructions) Thank you. I would now like to turn the call over to Derek Leckow. Please go ahead.
感謝您的支持。我叫 Jeannie,今天我將擔任您的會議接線生。現在,我歡迎大家參加 Exact Sciences 2025 年第二季財報電話會議。(操作員指示)謝謝。現在我想把電話轉給 Derek Leckow。請繼續。
Derek Leckow - Investor Relations
Derek Leckow - Investor Relations
Thank you for joining us for Exact Sciences second-quarter 2025 conference call. On the call today are Kevin Conroy, the company's Chairman and CEO; and Aaron Bloomer, our Chief Financial Officer. Exact Sciences issued a press release earlier this afternoon detailing our second quarter financial results. This news release and today's presentation are available on our website at exactsciences.com.
感謝您參加 Exact Sciences 2025 年第二季電話會議。今天參加電話會議的有公司董事長兼執行長凱文康羅伊 (Kevin Conroy) 和財務長亞倫布魯默 (Aaron Bloomer)。Exact Sciences 今天下午早些時候發布了一份新聞稿,詳細介紹了我們的第二季財務業績。本新聞稿和今天的簡報可在我們的網站 exactsciences.com 上查閱。
During today's call, we will make forward-looking statements based on current expectations. Our actual results may be materially different from such statements. Discussions of non-GAAP figures and reconciliations to GAAP figures are available in our earnings press release, and descriptions of the risks and uncertainties associated with Exact Sciences are included in our SEC filings. Both can be accessed through our website.
在今天的電話會議中,我們將根據目前的預期做出前瞻性陳述。我們的實際結果可能與此類陳述有重大差異。有關非 GAAP 數據和與 GAAP 數據的調節的討論可在我們的收益新聞稿中找到,與 Exact Sciences 相關的風險和不確定性的描述包含在我們的 SEC 文件中。兩者都可以透過我們的網站存取。
I'll now turn the call over to Kevin.
我現在將電話轉給凱文。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Thanks, Derek. During the second quarter, the Exact Sciences team delivered a record 1.3 million test results to patients, accelerated core revenue growth to 16% year over year and generated an all-time high $138 million in adjusted EBITDA.
謝謝,德里克。第二季度,Exact Sciences 團隊為患者提供了創紀錄的 130 萬份檢測結果,核心收入年增 16%,調整後 EBITDA 達到歷史最高水準 1.38 億美元。
As a result, we are raising guidance at midpoint for revenue by $55 million and adjusted EBITDA by $25 million. We also advanced our mission by expanding our agreement with two of our top 10 payers to make Cologuard Plus in network, entering an exclusive license with Freenome for blood-based colorectal cancer screening test. Gaining Medicare coverage for Oncodetect, our molecular residual disease test and announcing a multiyear productivity plan targeting $150 million in annual savings by 2026.
因此,我們將營收預期中位數上調 5,500 萬美元,將調整後 EBITDA 預期上調 2,500 萬美元。我們還透過擴大與十大付款人中的兩家的協議來推進我們的使命,在網路中生產 Cologuard Plus,並與 Freenome 簽訂了基於血液的結直腸癌篩檢測試的獨家許可。我們的分子殘留疾病檢測 Oncodetect 獲得醫療保險覆蓋,並宣布了一項多年生產力計劃,目標是到 2026 年每年節省 1.5 億美元。
Aaron will now review our second quarter results, updated guidance and multiyear productivity plan.
亞倫現在將回顧我們的第二季業績、最新指導和多年生產力計劃。
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Thanks, Kevin, and good afternoon, everyone. The Exact Sciences team delivered another strong quarter in both screening and precision oncology. Second-quarter revenue grew 16% on both a reported and core basis, $39 million above the midpoint of our guidance.
謝謝,凱文,大家下午好。Exact Sciences 團隊在篩檢和精準腫瘤學領域又取得了強勁的成績。第二季報告營收和核心收入均成長了 16%,比我們的預期中位數高出 3,900 萬美元。
Screening revenue increased 18% to $628 million, with Cologuard growth led by rescreens, care gap programs and improved commercial execution. Precision oncology revenue increased 9% to $179 million on a core basis.
篩檢收入成長 18% 至 6.28 億美元,其中 Cologuard 的成長主要得益於重新篩選、照護差距計畫和商業執行的改進。精準腫瘤學核心收入成長 9%,達到 1.79 億美元。
Growth was led by continued strength in Oncotype DX adoption internationally. We also recognized $7.5 million in revenue from sublicensing Twin Strands technology. Adjusted EBITDA increased 26% to a record $138 million. Adjusted EBITDA margin expanded 130 basis points driven by Cologuard plus pricing and productivity gains across our lab, supply chain, G&A and support functions.
成長主要得益於 Oncotype DX 在國際上的持續強勁應用。我們也從 Twin Strands 技術的再授權中獲得了 750 萬美元的收入。調整後的 EBITDA 成長 26%,達到創紀錄的 1.38 億美元。調整後的 EBITDA 利潤率擴大了 130 個基點,這得益於 Cologuard 以及實驗室、供應鏈、G&A 和支援職能部門的定價和生產力提升。
GAAP net income was negative $1 million, which included $15 million in onetime costs related to actions we took to increase operational efficiency and productivity over time. Free cash flow was $47 million, bringing year-to-date free cash flow to $46 million or an increase of $95 million to the same period last year.
GAAP 淨收入為負 100 萬美元,其中包括與我們為提高營運效率和生產力而採取的行動相關的 1500 萬美元的一次性成本。自由現金流為 4,700 萬美元,使年初至今的自由現金流達到 4,600 萬美元,比去年同期增加 9,500 萬美元。
As expected, the Cologuard Plus launch temporarily increased accounts receivable and impacted second quarter cash flows. These claims are now being paid and we expect this will increase cash flow in the second half of the year. This further strengthens our balance sheet and positions us to complete the anticipated Freenome transaction with cash on hand. We ended the quarter with $858 million in cash and marketable securities.
正如預期的那樣,Cologuard Plus 的推出暫時增加了應收帳款並影響了第二季的現金流。這些索賠目前正在支付,我們預計這將增加下半年的現金流。這進一步增強了我們的資產負債表,並使我們能夠利用手頭上的現金完成預期的 Freenome 交易。本季末,我們擁有 8.58 億美元的現金和有價證券。
Turning to guidance. We are raising total revenue guidance to between $3.13 billion and $3.17 billion for the year, an increase of $55 million at midpoint. With third quarter revenue between $800 million and $815 million.
轉向指導。我們將全年總收入預期上調至 31.3 億美元至 31.7 億美元之間,中間值增加 5,500 萬美元。第三季營收在8億美元至8.15億美元之間。
This assumes screening revenue between $630 million and $640 million for the third quarter and between $2.44 billion and $2.47 billion for the year. Precision oncology revenue between $170 million and $175 million for the third quarter and between $690 million and $700 million for the year.
假設第三季的放映收入在 6.3 億美元至 6.4 億美元之間,全年的放映收入在 24.4 億美元至 24.7 億美元之間。精準腫瘤學第三季營收在 1.7 億至 1.75 億美元之間,全年營收在 6.9 億至 7 億美元之間。
Annual guidance at midpoint implies total revenue growth of 14%, including 17% in screening and 6% in precision oncology. We are raising full-year adjusted EBITDA guidance by $25 million to between $455 million to $475 million for the full year.
中期年度指導意味著總收入成長 14%,其中篩檢收入成長 17%,精準腫瘤學收入成長 6%。我們將全年調整後 EBITDA 預期調高 2,500 萬美元,至 4.55 億美元至 4.75 億美元之間。
Guidance at midpoint implies more than 44% adjusted EBITDA growth or about 300 basis points of adjusted EBITDA margin expansion. For modeling purposes, please note, our adjusted EBITDA guidance does not reflect any potential impact from the Freenome licensing agreement announced today. We will provide updated guidance upon the close of the transaction.
中點指引意味著調整後的 EBITDA 成長超過 44%,或調整後的 EBITDA 利潤率擴大約 300 個基點。為了建模目的,請注意,我們調整後的 EBITDA 指南並未反映今天宣布的 Freenome 許可協議的任何潛在影響。我們將在交易完成後提供更新的指導。
We are introducing a multiyear productivity plan to strengthen our operational foundation and unlock meaningful cost synergies. With our flywheel fully engaged, this is the next step in driving long-term performance and we reaffirm our 2027 long-term target of 15% compounded revenue growth and more than 20% adjusted EBITDA margins, which we provided at our 2023 Investor Day. We expect to deliver more than $150 million in annual savings in 2026. Over $50 million of these savings are included in our 2025 guidance, including actions taken during the first quarter.
我們正在推出一項多年生產力計劃,以加強我們的營運基礎並釋放有意義的成本協同效應。隨著我們的飛輪全面啟動,這是推動長期業績的下一步,我們重申我們在 2023 年投資者日提供的 2027 年長期目標,即 15% 的複合收入增長和 20% 以上的調整後 EBITDA 利潤率。我們預計到 2026 年每年可節省超過 1.5 億美元。我們的 2025 年指導方針中包含了超過 5000 萬美元的節省,其中包括第一季採取的行動。
Savings will primarily come from G&A efficiencies through reducing external spend, restructuring support functions and accelerating the use of AI and automation in core operations. We anticipate approximately $105 million to $120 million in restructuring and transformation costs in total.
節省主要來自於透過減少外部支出、重組支援功能以及加速在核心營運中使用人工智慧和自動化來提高 G&A 效率。我們預計重組和轉型成本總計約為 1.05 億至 1.2 億美元。
For modeling purposes, we expect $90 million to $95 million of these costs to incur in 2025, inclusive of $40 million in actions already taken in the first half of the year. These efforts represent a pivotal step in strengthening our foundation for long-term success and continue investing in the highest impact areas towards advancing our mission, including research and development, lab and operational capacity and sales and marketing. Back to you, Kevin.
為了建立模型,我們預計 2025 年將產生 9,000 萬至 9,500 萬美元的成本,其中包括上半年已經採取的 4,000 萬美元的行動。這些努力代表我們加強長期成功基礎的關鍵一步,並將繼續投資於影響最大的領域以推進我們的使命,包括研發、實驗室和營運能力以及銷售和行銷。回到你身邊,凱文。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Thanks, Aaron. During the second quarter, we continued to gain momentum across our portfolio of advanced cancer tests, serving more patients and expanding the number of healthcare providers, health systems and payers who rely on Exact Sciences and the ExactNexus platform.
謝謝,亞倫。在第二季度,我們繼續在先進癌症檢測產品組合方面取得進展,為更多患者提供服務,並擴大依賴 Exact Sciences 和 ExactNexus 平台的醫療保健提供者、醫療系統和付款人的數量。
We delivered our 20 million Cologuard result, doubling from 10 million in just three years. We are encouraged by indicators of sustainable growth coming from our commercial organization. During the second quarter, sales for representative productivity in calls reached all-time highs, driven by better coverage, segmentation and targeting enhanced by AI.
我們實現了 2,000 萬的 Cologuard 業績,在短短三年內就從 1,000 萬翻了一番。我們商業組織的可持續成長指標令我們感到鼓舞。在第二季度,由於人工智慧增強了覆蓋範圍、細分和定位,代表通話效率的銷售額達到了歷史最高水準。
A record 200,000 providers ordered Cologuard with growth across all segments at record depth. Orders per provider grew strongly with robust growth among new customers. Accelerated growth in rescreen patients, driven by our enhanced patient navigation journeys. Cologuard brand awareness hit all-time highs with top-of-mind awareness matching or exceeding colonoscopy.
創紀錄的 20 萬家供應商訂購了 Cologuard,所有細分市場的成長都達到了創紀錄的深度。隨著新客戶數量的強勁成長,每個供應商的訂單量強勁成長。在我們增強的患者導航旅程的推動下,重新篩檢患者的數量加速成長。Cologuard 品牌知名度創歷史新高,其首要知名度與大腸鏡檢查相當甚至超過大腸鏡檢查。
2.5 billion media impressions driven by increased digital investment and customer initiated ordering grew triple digits as our team continues to enhance customer experience and better engage patients through our digital channels.
隨著我們的團隊繼續提升客戶體驗並透過數位管道更好地吸引患者,受數位投資增加和客戶發起訂單推動,媒體曝光量達到 25 億次,增長了三位數。
The colon cancer screening landscape is shifting towards a Cologuard first colonoscopy when needed approach. The AGA Work Group recently published a paper advocating that the most effective screening approach is to lead with a noninvasive stool test first.
大腸癌篩檢領域正在轉向在需要時首先進行 Cologuard 大腸鏡檢查的方法。AGA 工作小組最近發表了一篇論文,主張最有效的篩檢方法是先進行非侵入性糞便測試。
With colonoscopy backlogs extending for months, screening rates below target and incidents rising, especially with young adults, Cologuard is the most effective tool to improve screening rates. A decade in, Cologuard's momentum speaks for itself, and Cologuard Plus, possibly the most sensitive and specific noninvasive cancer screening test ever developed, accelerates our path to screening the next 20 million patients.
由於大腸鏡檢查積壓長達數月,篩檢率低於目標,且發生率上升,尤其是年輕人,Cologuard 是提高篩檢率最有效的工具。十年過去了,Cologuard 的發展勢頭不言而喻,而 Cologuard Plus 可能是迄今為止最敏感、最具體的非侵入性癌症篩檢測試,它加速了我們篩檢下一個 2000 萬患者的進程。
A special thanks to the Exact team for increasing access to Cologuard Plus by securing favorable contracts with 2 of the top 10 payers, Humana and Centene, which together represent about 40 million members. We also established positive coverage decisions with 8 of the top 10 payers.
特別感謝 Exact 團隊與十大付款人中的兩家 Humana 和 Centene 簽訂了優惠合同,從而增加了 Cologuard Plus 的訪問權限,這兩家公司總共擁有約 4000 萬會員。我們還與前 10 名付款人中的 8 名達成了積極的承保決定。
Turning to blood-based colorectal cancer screening. We tested samples from the pivotal BLUE-C study using a version of our blood-based colon cancer screening test. This test included 3 methylation markers and a protein marker.
轉向基於血液的結腸直腸癌篩檢。我們使用基於血液的結腸癌篩檢測試版本對關鍵的 BLUE-C 研究中的樣本進行了測試。該測試包括 3 個甲基化標記和一個蛋白質標記。
It did not include the additional marker class presented at the ESMO 2024 Congress. Initial testing showed sensitivities of 73% for colon cancer and 14% for advanced precancerous lesions at 90% specificity. Although we met the primary endpoint of the pivotal study, we are disappointed with these results.
它不包括在 ESMO 2024 大會上提出的額外標記類。初步檢測顯示,結腸癌的敏感性為 73%,對晚期癌前病變的敏感性為 14%,特異性為 90%。儘管我們達到了關鍵研究的主要終點,但我們對這些結果感到失望。
Science is not always a straight path, and we are proud of our R&D team's work. We gained many insights that we believe will lead to future portfolio benefits. We are continuing internal testing and evaluation. Because we have not yet made an FDA submission, we will not presently be providing additional color on our program.
科學並不總是一條筆直的道路,我們為我們的研發團隊的工作感到自豪。我們獲得了許多見解,相信這些見解將為未來的投資組合帶來收益。我們正在繼續內部測試和評估。由於我們尚未向 FDA 提交申請,因此目前我們不會提供有關我們計劃的更多詳細資訊。
As we announced earlier today, we acquired exclusive rights to the current and future versions of Freenome's blood-based colon cancer screening tests and underlying technology subject to customary regulatory approvals.
正如我們今天早些時候宣布的那樣,我們獲得了 Freenome 基於血液的結腸癌篩檢測試和基礎技術的當前和未來版本的獨家權利,但須遵守慣例監管部門的批准。
In June, complete results for the first version test were published in JAMA. The Freenome team has submitted the last module of the premarket application to the FDA. Freenome is also advancing a next-generation version of the test that is designed to improve advanced pre-cancer solution sensitivity.
6 月,第一版測試的完整結果在 JAMA 上發表。Freenome團隊已經向FDA提交了上市前申請的最後一個模組。Freenome 也正在推動該測試的下一代版本,旨在提高晚期癌前解決方案的敏感度。
Blood-based colon cancer screening test can help get on screen people screen. Guideline groups, such as USPSTF typically relying on modeling studies to inform their recommendations by evaluating the balance of benefit to burden to determine the most efficient screening strategy.
基於血液的大腸癌篩檢測試可以幫助人們進行篩檢。指南小組(例如 USPSTF)通常依靠建模研究來提供建議,透過評估效益與負擔的平衡來確定最有效的篩檢策略。
Results from our recent modeling analysis clearly show that only Cologuard Plus and colonoscopy maximize the benefits to harm ratios over the guideline recommended age range. This aligns with the NCCN recommendation which positions blood test as an option when patients are unwilling to complete frontline guideline recommended tests such as Cologuard or colonoscopy.
我們最近的建模分析結果清楚地表明,只有 Cologuard Plus 和結腸鏡檢查才能在指南建議的年齡範圍內最大限度地提高益處與危害的比率。這符合 NCCN 的建議,當患者不願意完成第一線指南建議的測試(例如 Cologuard 或大腸鏡檢查)時,血液測試是一種選擇。
Together, these screening tools can expand access, drive better outcomes across broad populations. With Cologuard Plus, the most accurate guideline included stool test and now a blood-based screening test, we've created a portfolio designed to continue leading cancer screening.
這些篩檢工具結合起來可以擴大覆蓋範圍,為廣大人群帶來更好的結果。透過 Cologuard Plus,最準確的指南包括糞便測試和現在的血液篩檢測試,我們創建了一個旨在繼續引領癌症篩檢的產品組合。
These tests will be powered by the strong foundation and scale we built. First, we have the largest and most effective cancer diagnostics commercial organization in primary care, a segment where education and engagement are critical.
這些測試將由我們建立的堅實基礎和規模提供支援。首先,我們擁有初級保健領域最大、最有效的癌症診斷商業組織,而初級保健領域的教育和參與至關重要。
Second, the scale and infrastructure of our data, we have a large customer base of providers and the tools to identify those who have refused guideline recommended tests. Third, our deep relationships. We can reach these patients through deep relationships with payers, electronic connections to nearly 400 health systems and over 250,000 ordering healthcare providers each year.
其次,我們的資料規模和基礎設施,我們擁有龐大的供應商客戶群和識別那些拒絕指南推薦測試的人的工具。第三,我們的深厚關係。我們可以透過與付款人建立深厚的關係、每年與近 400 個醫療系統和超過 250,000 個訂購醫療保健提供者的電子連接來接觸這些患者。
This reach is connected and powered by our ExactNexus technology, which uses advanced analytics and smart tools to make the process seamless from order to result. This foundation enables us to scale, drive awareness and build the most trusted brands in cancer screening.
這一範圍由我們的 ExactNexus 技術連接和支持,該技術使用先進的分析和智慧工具使從訂單到結果的流程變得無縫銜接。該基金會使我們能夠擴大規模、提高意識並打造癌症篩檢領域最值得信賴的品牌。
Next month, we are launching Cancer Guard, our blood-based multi-cancer early detection test. Cancer Guard is designed to address the approximately 70% of cancers that currently lack a recommended screening solution.
下個月,我們將推出基於血液的多種癌症早期檢測測試「Cancer Guard」。Cancer Guard 旨在解決目前缺乏建議篩檢解決方案的約 70% 的癌症。
This represents a significant unmet clinical need, translating to a largely untapped $25 billion addressable market. We are uniquely positioned to bring Cancer Guard to patients by leveraging our commercial and operational scale.
這代表著巨大的未滿足的臨床需求,意味著一個很大程度上尚未開發的250億美元潛在市場。我們利用自己的商業和營運規模,為患者提供獨特的癌症衛士服務。
We have over 1,000 reps calling on primary care physicians, oncologists and health systems. Our patient navigation engine delivers millions of multimodal touch points to millions of patients annually. We have world-class lab operations, quality systems and operational capabilities.
我們有超過 1,000 名代表致電初級保健醫生、腫瘤學家和衛生系統。我們的患者導航引擎每年為數百萬患者提供數百萬個多模式接觸點。我們擁有世界一流的實驗室運作、品質系統和營運能力。
We also have the ability to reach patients and providers with powerful digital tools through our ExactNexus technology. We are confident in our ability to lead the MSD market. Backed by our clinical evidence, we are energized by the opportunity over time to help reduce cancer-related mortality.
我們還能夠透過我們的 ExactNexus 技術為患者和服務提供者提供強大的數位工具。我們有信心引領 MSD 市場。憑藉臨床證據,我們有機會隨著時間的推移幫助降低癌症相關的死亡率。
During the second quarter, our Precision Oncology team unlocked access for cancer patients by securing Medicare reimbursement for OncoDetect. Combining data from the beta correct study shared at ASCO with prior research helped secure broad coverage for Stages 2 through 4 colorectal cancer patients.
在第二季度,我們的精準腫瘤學團隊透過確保 OncoDetect 獲得醫療保險報銷,為癌症患者解鎖了治療機會。將 ASCO 上分享的 beta 正確研究數據與先前的研究相結合,有助於確保對 2 至 4 期結直腸癌患者的廣泛覆蓋。
This supports our belief that Oncodetect will play a critical role in monitoring and guiding treatment after a patient's cancer diagnosis. We're proud of our team for focusing on what matters most and we're more energized than ever on the road ahead.
這支持了我們的信念,即 Oncodetect 將在患者癌症診斷後的監測和指導治療中發揮關鍵作用。我們為我們的團隊專注於最重要的事情而感到自豪,並且我們在未來的道路上比以往任何時候都更有活力。
Together, we're expanding our portfolio, increasing access and strengthening our platform for long-term impact. We're positioned not just to lead but to transform how cancer is detected and treated. That's how we will achieve our purpose of eradicating cancer and the suffering of causes.
我們正在共同擴大我們的產品組合,增加訪問量並加強我們的平台以產生長期影響。我們的定位不僅是引領,而且是改變癌症的檢測和治療方式。這樣我們才能實現消除癌症及其病因痛苦的目標。
We're now happy to answer your questions.
我們現在很高興回答您的問題。
Operator
Operator
(Operator Instructions) Andrew Brackman, William Blair.
(操作員指示)安德魯·布拉克曼,威廉·布萊爾。
Andrew Brackmann - Analyst
Andrew Brackmann - Analyst
Hi guys, good afternoon. Thanks for taking the question. Kevin, you sound excited about the opportunity with Freenome. Can you maybe just sort of unpack for us a bit more the strategic fit that this agreement has for Exact and how the product can further round out the portfolio that you have? Thanks.
大家好,下午好。感謝您回答這個問題。凱文,聽起來你對與 Freenome 合作的機會感到很興奮。您能否為我們進一步闡述該協議對 Exact 的策略契合度,以及該產品如何進一步完善您的產品組合?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Yeah. Thanks, Andrew. First of all, in CRC screening, we're a clear leader in this -- clear leader in the noninvasive screening market. With Cologuard Plus, we have the most accurate CRC screening test. Yet there is a role for blood to play.
是的。謝謝,安德魯。首先,在 CRC 篩檢方面,我們是非侵入性篩檢市場的明顯領導者。有了 Cologuard Plus,我們就有了最精確的 CRC 篩檢測試。然而血液還是發揮作用。
This agreement adds a blood-based option to our portfolio of test, Cologuard, Cologuard Plus, now a blood CRC test and a multi-cancer screening test Cancer guard. So we have a portfolio. It's supported by our platform, our commercial infrastructure, which is second to none, healthcare provider relationships, as you just heard, over 200,000 ordering healthcare providers in the quarter and just tremendous growth.
該協議為我們的測試組合增加了基於血液的選項,Cologuard、Cologuard Plus,現在是一种血液 CRC 測試和多癌症篩檢測試 Cancer guard。所以我們有投資組合。它得到了我們平台、商業基礎設施的支持,這些都是首屈一指的,還有醫療保健提供者關係,正如您剛才聽到的,本季度有超過 200,000 個訂購醫療保健提供商,而且增長非常迅速。
Here's what we are excited about, about the Freenome technology. Their B1 test has strong data, and it accelerates our time to market. Version 2 shows potential promise. We've seen data there that shows potentially improved APL detection.
以下是我們對 Freenome 技術感到興奮的地方。他們的 B1 測試擁有強大的數據,它加快了我們的產品上市時間。版本 2 顯示出了潛在的前景。我們已經看到了表明 APL 檢測可能得到改善的數據。
Now this is from a holdout portion of their preempt study, and that gives us -- we have the optionality to take that technology should in the pivotal study and the readout that we will be able to deploy that test if it does indeed have improved performance.
現在,這是他們先發製人研究的一部分,這給了我們 - 我們可以選擇在關鍵研究中採用該技術,並且如果該技術確實提高了性能,我們將能夠部署該測試。
So the structure gives us maximum flexibility as we continue to lead in this market. So that's what we like. It's a great technology. We have optionality, we have flexibility. And all of that leads to an impact in a field that we're currently leading.
因此,這種結構為我們提供了最大的靈活性,使我們繼續在這個市場上保持領先地位。這就是我們喜歡的。這是一項偉大的技術。我們有選擇性,我們有彈性。所有這些都會對我們目前處於領先地位的領域產生影響。
Operator
Operator
Brandon Couillard, Wells Fargo.
布蘭登‧庫亞爾 (Brandon Couillard),富國銀行。
Brandon Couillard - Equity Analyst
Brandon Couillard - Equity Analyst
Hey, thanks, good afternoon. Aaron, can you walk us through the beat on the quarter and kind of what's contributing to the strong first half growth of the core business, if you help if you could unpack all the factors behind the momentum and maybe talk about sustainability? Thanks.
嘿,謝謝,下午好。亞倫,您能否向我們介紹本季的業績以及核心業務上半年強勁成長的因素?如果您能幫忙分析這一成長動能背後的所有因素,並談談永續性嗎?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Thanks, Brandon, it's Kevin. I'll take the first part and then pass it over to Aaron. So there have just been multiple tailwinds here. And it really starts with the launch of Cologuard Plus and the incredible work that our commercial team has done. The commercial organization is doing a great job.
謝謝,布蘭登,我是凱文。我將負責第一部分,然後將其交給 Aaron。所以這裡出現了多個順風。這一切始於 Cologuard Plus 的推出以及我們的商業團隊所做的出色工作。該商業組織做得很好。
Cologuard Plus is getting them greater access. Our customer base is energized by a test that is 95% sensitivity and 94% specificity. We've seen strength in rescreens, care gap programs. Our brand awareness has never been higher.
Cologuard Plus 為他們提供了更大的存取權限。我們的客戶群對敏感性 95%、特異性 94% 的測試充滿熱情。我們已經看到了重新篩選和護理差距計劃的優勢。我們的品牌知名度從未如此高。
Aaron, do you want to go -- dive into the details a little more?
亞倫,你想更深入了解細節嗎?
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Thanks, Kevin. Thanks, Brandon. Yeah, so we beat by $40 million on the top line with really strength across all parts of the business, specifically within Cologuard. And I would highlight comments that we've made in the past. We just continue to see momentum from the commercial improvements that we've made, and that is what is contributing to the majority of the beat.
謝謝,凱文。謝謝,布蘭登。是的,我們的營業額超出預期 4000 萬美元,這得益於我們所有業務部門的強勁表現,尤其是 Cologuard。我想強調一下我們過去所發表的評論。我們只是繼續看到我們所做的商業改進所帶來的動力,而這正是對大部分節拍的貢獻。
But we are seeing strength from everything, whether it's from the traditional where our reps are calling it on point of care, our new care gap programs, which continues to accelerate our new customer initiated ordering platform as well as then from our rescreens and the recent launch of Cologuard Plus.
但是,我們看到了各方面的力量,無論是來自我們的代表所說的傳統的護理點,還是我們的新護理差距計劃,這繼續加速我們新客戶發起的訂購平台,以及來自我們的重新篩選和最近推出的 Cologuard Plus。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
I think I'd add one other thing to that with other aspiring entrants into this market out there calling on physicians. What we have seen is an overall lift to Cologuard. So we think more attention in this market is leading to more awareness and reminding physicians, especially in the busy primary care segment to think about making sure their patient is up to date with colon cancer screening and what comes to mind first is Cologuard.
我認為我還要補充一點,其他有抱負進入這個市場的人也在呼籲醫生。我們看到的是 Cologuard 的整體提升。因此,我們認為,對這個市場的更多關注將提高人們的認識,並提醒醫生,特別是在繁忙的初級保健領域,要考慮確保他們的患者及時接受結腸癌篩檢,而首先想到的就是 Cologuard。
Operator
Operator
Catherine Schulte, Baird.
凱瑟琳舒爾特,貝爾德。
Catherine Schulte - Analyst
Catherine Schulte - Analyst
Okay, thanks for the questions. Maybe just first on the blood data. As you look back, have you been able to identify the drivers of the more severe degradation than you expected? And then you mentioned Freenome has submitted the final module of its PMA. I guess, what's the expected time line for an FDA decision? And do you expect there to be another AdCom?
好的,謝謝你的提問。也許首先要了解的是血液數據。回顧過去,您是否能夠找出導致比您預期更為嚴重的退化的原因?然後您提到 Freenome 已經提交了其 PMA 的最終模組。我想問一下,FDA 做出決定的預計時間是什麼時候?您是否預計還會有另一個 AdCom?
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Well, thanks, Catherine. Science is obviously not linear. And we haven't submitted yet to the FDA. Testing continues and work on that program continues. Because we haven't submitted to the FDA, we're not in a position to comment publicly on all of the inner workings.
好吧,謝謝你,凱瑟琳。科學顯然不是線性的。我們還沒有向 FDA 提交。測試仍在繼續,該計劃的工作也將繼續進行。由於我們尚未向 FDA 提交申請,因此我們無法公開評論所有內部運作。
So I would say why we believe we'll win in blood with this new program, first of all, Freenome's test delivered 81% sensitivity for cancer, 14% for pre-cancer at a 90% specificity. And I want to make this clear. This test is now ours. We exclusively licensed it. We're very excited about bringing it to a niche in the market that is an important one.
所以我想說為什麼我們相信我們會透過這個新項目在血液檢測中獲勝,首先,Freenome 的測試對癌症的敏感性為 81%,對癌前病變的敏感性為 14%,特異性為 90%。我想把這一點講清楚。現在這個考驗屬於我們了。我們對其進行了獨家授權。我們非常高興能夠將它帶入市場中一個重要的利基市場。
They have submitted the final module to the FDA, we're not going to guess how long that will take. So I think you can take a look at what is typical out there, but we're not going to guesstimate at this time. . And remember, we have a tremendously large sales force that will be excited to have a blood test in their hand. And the niche of patients that will benefit from a blood-based colon cancer screening test are those patients who refuse a frontline guideline recommended test.
他們已經向 FDA 提交了最終模組,我們無法猜測這需要多長時間。所以我認為你可以看看那裡的典型情況,但我們現在不會進行猜測。。請記住,我們擁有一支龐大的銷售隊伍,他們非常樂意接受血液檢測。而受益於血液結腸癌篩檢測試的患者群體是那些拒絕接受第一線指南推薦測試的患者。
The NCCN guidelines were clear that there is a role for blood-based testing and it's for those patients who are active refusers of screening. So could this ultimately represent a meaningful niche in the market? Yes, we believe it can. And we believe we have the relationships with the healthcare providers, with patients and their trust the quality that we've delivered over the last 11 years with Cologuard.
NCCN 指南明確指出,血液檢測具有重要意義,它適用於那些主動拒絕篩檢的患者。那麼這最終能否代表市場中的一個有意義的利基市場呢?是的,我們相信可以。我們相信,我們與醫療保健提供者和患者建立了良好的關係,他們也信任我們在過去 11 年為 Cologuard 提供的品質。
Operator
Operator
Doug Schenkel, Wolfe Research.
道格‧申克爾,沃爾夫研究中心。
Doug Schenkel - Equity Analyst
Doug Schenkel - Equity Analyst
Kevin, let me -- well, first off thank you for taking the questions. So let me start with the positive. Via the license you seem well positioned to have access to an FDA-approved product. You probably can launch it within the next 18 months, and you have the commercial infrastructure to really get after this market with existing relationships. So those are clear positives. Now let's to be balanced to talk about the negatives.
凱文,首先感謝您回答這些問題。那麼讓我先從正面的方面開始。透過該許可證,您似乎可以獲得 FDA 批准的產品。您可能可以在未來 18 個月內推出它,並且您擁有利用現有關係真正進入這個市場的商業基礎設施。這些都是明顯正面的面向。現在讓我們平衡地談論一下負面因素。
So as I mentioned and I use the word access to a product, because you didn't develop it. You have definitely been great in stool, but CRC blood was acquired via a life. Oncotype was acquired. Beyond stool, the ROI on R&D hasn't been great. And frankly, M&A hasn't been great. Drive looks like a mistake, and there's other examples.
正如我所提到的,我使用“訪問產品”這個詞,因為你沒有開發它。您的大便確實很棒,但是 CRC 血液是透過生命獲得的。Oncotype 被收購。除了凳子之外,研發的投資報酬率並不高。坦白說,併購情況並不理想。駕駛看起來像是一個錯誤,還有其他例子。
I think it's fair to say there's questions about billions of dollars of M&A spend and $400 million in annual R&D from an ROI standpoint. So my first question is this. What changes now in terms of resource allocation, operational spends? And how do you change and improve strategic prioritization? What are the lessons here? And how do you want investors to think of Exact through this lens.
我認為,從投資報酬率的角度來看,數十億美元的併購支出和每年 4 億美元的研發支出存在疑問。所以我的第一個問題是這樣的。在資源分配和營運支出方面現在有哪些變化?您如何改變和改善策略優先順序?這為我們帶來了什麼教訓?您希望投資者如何從這個角度看待 Exact。
Second, specific to CRC, presumably due to the COGS profile of Freenome, your stance on testing interval flexibility has changed. I want to confirm that's right. Essentially, is the position now that you will be the number two entrant to the CRC blood screening market, and you view this as a multiplayer market test area going after the screening resistant population of about 45 million people and that this will have a three-year interval. Third, my last question, why shouldn't investors now think that you view blood as a threat to Cologuard given the quick pivot on this data to quickly make a deal with Freenome? Thank you.
其次,具體到 CRC,大概是由於 Freenome 的 COGS 概況,您對測試間隔彈性的立場改變了。我想確認這是正確的。從本質上講,現在的情況是,您將成為 CRC 血液篩檢市場的第二大進入者,並且您將此視為一個多方市場測試領域,目標是針對約 4500 萬人的篩檢抗藥性人群,並且這將有三年的間隔。第三,我的最後一個問題,既然你迅速利用這些數據與 Freenome 達成協議,那麼為什麼投資者現在不應該認為你認為血液對 Cologuard 構成了威脅呢?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
I think there were multiple questions and multiple -- there was a long dialogue in there. And I would start, Doug, by saying I disagree with your conclusion that the Genomic Health acquisition was not a successful one. I also disagree that the Thrive acquisition is not successful. We will be launching Cancer Guard next month. And the MSET technology that, that relies on was fundamental to the -- was a part of the Thrive acquisition.
我認為其中有多個問題和多個問題——其中有一段很長的對話。道格,首先我想說,我不同意你關於 Genomic Health 收購並不成功的結論。我也不同意 Thrive 收購不成功。我們將於下個月啟動「癌症衛士」計畫。所依賴的 MSET 技術是 Thrive 收購的基礎。
So we just have a fundamental disagreement there. I don't think that you probably fully understand the potential of that multi-cancer screening market. And I would also say, you probably, Doug, don't understand the power of our commercial organization, based upon the question you asked, which is okay.
所以我們在這方面有根本分歧。我認為您可能還沒有完全了解多癌症篩檢市場的潛力。而且我還想說,道格,根據你提出的問題,你可能不了解我們商業組織的力量,沒關係。
But the commercial organization just delivered an unbelievable quarter, two quarters in a row. And what we have seen year over year in the 11 years since we've launched Cologuard, and let's take a step back and think about this impact.
但該商業組織剛剛連續兩個季度取得了令人難以置信的業績。自從我們推出 Cologuard 以來的 11 年裡,我們每年都看到它的變化,讓我們回顧一下它的影響。
We've seen over 100,000 people, probably about 120,000 people diagnosed earlier with Cologuard than they would have been otherwise with cancer. The impact is huge. Over 600,000 people with precancerous polyps, leading to potential prevention. And finally, the mortality rate since Cologuard was launched, has declined 11%. So if you want to talk about productivity and R&D, we're happy to have that debate.
我們已經看到超過 10 萬人,大概 12 萬人透過服用 Cologuard 而比原本可能罹患癌症的人更早得到診斷。影響是巨大的。超過 60 萬人患有癌前息肉,從而實現潛在的預防。最後,自 Cologuard 推出以來,死亡率下降了 11%。因此,如果您想談論生產力和研發,我們很樂意進行辯論。
Our R&D investment has been over 50%, if you look cumulatively in the CRC screening place where we have clear leadership. And so that leadership will continue. In terms of blood-based screening, I think that you probably have that market not fully understood. If you take a look at the size of that market, it is small. Blood-based screening is not recommended by guidelines at this point in time.
如果累計來看,我們在 CRC 篩選領域有明顯的領先地位,我們的研發投入已經超過 50%。這樣,我們的領導地位就能夠持續下去。就血液篩檢而言,我認為您可能還沒有完全了解這個市場。如果你看一下這個市場的規模,你會發現它很小。目前指引並不建議進行血液篩檢。
The pivotal guideline group USPS may not weigh in for a number of years. And the data of any of these blood tests just does not hold a candle to colonoscopy. It doesn't hold a candle to Cologuard and to date, it doesn't hold the candle to a fifth test in terms of precancer detection.
關鍵指導方針小組 USPS 可能在幾年內都不會發表意見。任何血液檢查的數據都無法與大腸鏡檢查的數據相比。它無法與 Cologuard 相提並論,而且到目前為止,在癌前檢測方面,它也無法與第五種測試相提並論。
So we will see how that market develops. We are the company that has the ability to reach hundreds of thousands of physicians who have a need to deploy cancer screening technologies to their patients who need it.
因此我們將觀察該市場如何發展。我們是一家有能力接觸數十萬需要為有需要的患者部署癌症篩檢技術的醫生的公司。
And that is where our new blood test based on the Freenome PMA submission will be deployed. We welcome competition in that space. We -- and our team is ready to deploy test to those patients who truly refuse both a colonoscopy and Cologuard. There is a very real market to be able to reach those patients. But until blood testing is fully deployed and is in guidelines, which is a big question, we think that your view on this is probably different than our view.
這就是我們基於 Freenome PMA 提交的新血液檢查將要部署的地方。我們歡迎該領域的競爭。我們—以及我們的團隊已準備好對那些真正拒絕接受大腸鏡檢查和 Cologuard 治療的患者進行測試。存在一個能夠接觸到這些患者的真正市場。但在血液檢測全面部署並納入指導方針之前(這是一個大問題),我們認為您對此的看法可能與我們的看法不同。
Operator
Operator
Tycho Peterson, Jefferies.
傑富瑞 (Jefferies) 的 Tycho Peterson。
Tycho Peterson - Analyst
Tycho Peterson - Analyst
Hey, thanks. A few follow-ups on the deal here. Kevin, given going external was not necessarily part of the plan at least publicly discussed. Anything you can provide on time lines. Doug alluded to the fact that this came together quickly. How should we think about the timing of the next-gen test?
嘿,謝謝。這裡有一些關於該交易的後續情況。凱文,鑑於外部化不一定是計劃的一部分,至少是公開討論過。您可以按時提供任何資訊。道格暗示這一切很快就完成了。我們該如何考慮下一代測驗的時機?
And how much better do you think it will be at AA. What can you say on the cost structure, cost per test, given that it's NGS-based? And then I guess, lastly, I appreciate this deal structure gives you a lot of flexibility, but you are committing to a potential 10% royalty. Why was this the right structure as opposed to M&A with real earnouts in an aggressive integration program where you get all the IP, cash in the balance sheet and not have to pay a royalty? Thanks.
您認為在AA方面會有多大改進?考慮到它是基於NGS的,您能談談成本結構和每次測試的成本嗎?最後,我想,我很欣賞這種交易結構給你很大的靈活性,但你承諾支付潛在的 10% 的版稅。為什麼這種結構是正確的,而不是像積極的整合計劃中那樣通過真正的盈利進行併購,在併購中你可以獲得所有的知識產權、資產負債表中的現金,而且不必支付特許權使用費?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
All right. So the deal structure that we have here with the royalty, we think is one that makes sense over the long haul. And we'll see how all of this develops as the years go on. But what it does is gives us access for a modest investment. And thankfully, we have the balance sheet and the strong financial profile to be able to deliver.
好的。因此,我們認為,我們與特許權使用費達成的交易結構從長遠來看是合理的。隨著時間的推移,我們將看到這一切將如何發展。但它的作用是讓我們以適度的投資來獲得這一途徑。值得慶幸的是,我們擁有資產負債表和強大的財務狀況,能夠實現這一目標。
In terms of time lines, the -- a typical PMA is about a year from submission. That is not what we are guiding to, to be clear, because we don't know all of the dynamics that will occur or could it be shorter? Yes. Could it be longer? Yes, we don't know at this juncture.
就時間軸而言,典型的 PMA 從提交到批准大約需要一年時間。需要明確的是,這不是我們所引導的,因為我們不知道將會發生的所有動態,或者它可以更短嗎?是的。可以再長一點嗎?是的,目前我們還不知道。
In terms of AA detection, the only thing that we -- well, I guess I'll say two things. Number one is Freenome intends to disclose their AA data at the appropriate scientific congress. And I think that will be in the nearer term. Ultimately, that will be up to them.
就 AA 檢測而言,我們唯一要說的是——嗯,我想我會說兩件事。第一,Freenome 打算在適當的科學大會上揭露他們的 AA 數據。我認為這將在近期實現。最終,這取決於他們。
Secondly, we have built into this agreement that if AA detection does not achieve greater than 19%, we have the ability to exit the agreement. And then finally, I would say our internal program will continue and -- so maybe, Aaron, you would want to comment on the cost structure.
其次,我們在協議中規定,如果 AA 檢測率未達 19% 以上,我們有權退出協議。最後,我想說我們的內部計劃將繼續進行——所以也許,Aaron,你想對成本結構發表評論。
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
So from a cost of goods sold perspective, yes, it's sequencing. We haven't yet determined where we're going to price this product. But again, Kevin talked about all of the optionality and flexibility that we get with this deal, I would just reiterate, we will drive cost down over time on this specific test particularly as it scales and gets in the hand of our commercial organization, we're able to drive volume. And then from a broader macro perspective, I think this quarter is good evidence.
因此,從銷售成本的角度來看,是的,這是排序。我們尚未確定該產品的定價。但是,凱文再次談到了我們透過這筆交易獲得的所有可選性和靈活性,我只想重申一下,我們將隨著時間的推移降低這項特定測試的成本,特別是當它擴大規模並掌握在我們商業組織的手中時,我們能夠提高產量。然後從更廣泛的宏觀角度來看,我認為本季就是很好的證據。
Our guide is good evidence that we have so many different levers to continue to not only expand gross margins, but importantly, total profitability, which is just going to further strengthen that already strong financial profile Kevin alluded to.
我們的指南充分證明,我們擁有許多不同的槓桿,不僅可以繼續擴大毛利率,更重要的是,可以擴大總獲利能力,這將進一步加強凱文提到的已經很強大的財務狀況。
Operator
Operator
Jack Meehan, Nephron Research.
傑克·米漢(Jack Meehan),腎元研究。
Jack Meehan - Equity Analyst
Jack Meehan - Equity Analyst
Thank you. Good afternoon. I wanted to ask about CRC competition in a slightly different way. Now with Garden on the market, can you just talk about what you're seeing in terms of the real-world adoption of blood in terms of the interplay versus existing methods like Cologuard.
謝謝。午安.我想以稍微不同的方式詢問有關 CRC 競爭的問題。現在 Garden 已經上市,您能否談談就現實世界血液應用而言,與 Cologuard 等現有方法相比,其互動情況如何?
And as you look at the Freenome data and the way that the test is developed, do you think it can be differentiated? Or do you see this kind of standing kind of like in line with the way Garden is positioning Shield? Thank you.
當您查看 Freenome 資料和測試開發方式時,您認為它可以區分嗎?或者您認為這種站位與 Garden 定位 Shield 的方式一致?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Sure. It's been interesting. We're not seeing that the current promotional activity is diminishing Cologuard orders. In fact, the opposite seems to be occurring. The more the aspiring entrants talks to healthcare providers, especially those that are our customers the more we see growth in Cologuard utilization.
當然。這很有趣。我們沒有看到目前的促銷活動正在減少 Cologuard 的訂單。事實上,情況似乎正在相反。有抱負的進入者與醫療保健提供者(尤其是我們的客戶)的交流越多,我們就越能看到 Cologuard 利用率的成長。
So we think what's happening is sales reps are going into offices and reminding HCPs about the importance of colon cancer screening and they're reflexing to Cologuard. We saw the same dynamic when we launched Cologuard, that colonoscopy utilization increased.
因此,我們認為正在發生的情況是銷售代表走進辦公室並提醒 HCP 結腸癌篩檢的重要性,並且他們正在對 Cologuard 做出反應。當我們推出 Cologuard 時,我們看到了同樣的動態,即大腸鏡檢查的使用率增加了。
We -- so we have tremendous goodwill with HCP customers. And these primary care customers see a role for CRC blood testing, and many of them have told us that they intend to wait until we bring a test to market where you can imagine they worked with us for over a decade.
因此,我們與 HCP 客戶之間有著深厚的友誼。這些初級保健客戶看到了 CRC 血液檢測的作用,他們中的許多人告訴我們,他們打算等到我們將檢測推向市場,你可以想像他們與我們合作了十多年。
They know that we stand for quality. They have easy electronic ordering, electronic resulting a customer care hotline that they can call with any questions, and they know their patients will be treated well. So we think that all of this leads to a strong option for us to really take care of this niche patient.
他們知道我們代表著品質。他們擁有便利的電子訂購服務,並設有電子客戶服務熱線,他們可以撥打該熱線詢問任何問題,而且他們知道他們的患者會得到良好的治療。因此,我們認為所有這些都為我們真正照顧這個特殊患者提供了一個強有力的選擇。
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Jack, maybe one other thing to add on that, too, that I think is an important point. Aspire entrance has now been out in the market for a bit. And while they continue to drive some limited adoption, we just put up an 18% growth quarter in screening. We're guiding to a 17% growth in the back half of the year and for the full year. And so to Kevin's point, we have multiple drivers of tailwinds for this year and years to come in our core Cologuard business as well.
傑克,也許還有一點要補充,我認為這是一個重要的觀點。Aspire 入口現已在市場上推出一段時間了。儘管他們繼續推動有限的採用,但我們的篩選率剛剛實現了 18% 的成長。我們預計今年下半年和全年的成長率將達到 17%。正如凱文所說,今年以及未來幾年,我們的核心 Cologuard 業務也面臨多重順風驅動因素。
Operator
Operator
Vijay Kumar, Evercore ISI.
維傑·庫馬爾(Vijay Kumar),Evercore ISI。
Vijay Kumar - Analyst
Vijay Kumar - Analyst
Hey guys, thanks for taking my question. Maybe I'll pivot to the guidance and P&L here. Maybe can you talk about gross margins here for second quarter? What drove the sequential step down on the guidance to your earlier point, Aaron, 18% growth here in second quarter moderating to 17% in the back half. What drives the moderation, did your assumptions on pricing change at all versus prior? Thank you.
嘿夥計們,謝謝你們回答我的問題。也許我會轉向這裡的指導和損益表。您能談談第二季的毛利率嗎?Aaron,是什麼原因導致您先前對預期進行了連續下調,第二季的成長率為 18%,而下半年則放緩至 17%。是什麼導致了價格的緩和?與之前相比,您對定價的假設是否有所改變?謝謝。
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
First, just on the second quarter gross margin, it was down slightly sequentially and year over year, that just had to do with the timing of some of our care gap orders. We had our largest ever care gap order ship out at the end of the second quarter, which we would expect to see now results flowing in here in Q3. If you back that out, gross margins would have been up sequentially and year over year.
首先,僅就第二季的毛利率而言,它與上一季和去年同期相比略有下降,這與我們的部分護理差距訂單的時間有關。我們在第二季末發出了有史以來最大的護理缺口訂單,我們預計第三季將出現結果。如果你推翻這個假設,毛利率將會逐季上升,並且逐年上升。
And so I think this dynamic that's taking place with our care gap business, it's going to create some quarter-to-quarter fluctuations in our gross margin. But as we commented on in the past, we still expect gross margin expansion for the full year and obviously, meaningful adjusted EBITDA expansion as these programs are highly, highly accretive to total profitability.
因此,我認為我們的護理差距業務中出現的這種動態將導致我們的毛利率出現季度波動。但正如我們過去所評論的那樣,我們仍然預計全年毛利率將擴大,而且顯然調整後的 EBITDA 將大幅擴大,因為這些項目對總盈利能力的增值作用非常大。
And then as we're looking at the back half of the year guide, what I would say is we continue to see the positive signals on the new to Cologuard orders, the commercial strength that we talked about, our care gap orders.
然後,當我們回顧下半年的指南時,我想說的是,我們繼續看到有關 Cologuard 新訂單、我們談到的商業實力以及我們的護理差距訂單的積極信號。
And ultimately, we feel really good about the business and the progress that we've made. But if you look at kind of sequentially Q2 to Q3 as well as from a year-over-year perspective, it's kind of in line with what we've done in the past. And so no change to pricing assumptions midpoint of our guide, we would say it's the most likely outcome for the back half of the year.
最終,我們對業務和所取得的進展感到非常滿意。但如果你連續查看第二季到第三季以及同比情況,你會發現它與我們過去的做法是一致的。因此,我們的指南中點的定價假設沒有變化,我們認為這是今年下半年最有可能的結果。
Operator
Operator
Dan Brennan, Cowen.
丹布倫南,考恩。
Daniel Brennan - Analyst
Daniel Brennan - Analyst
Great, thank you. I'm taking the questions here. Maybe just a multi-partner. I think in the past, my impression was the exact team may have harbored some skepticism towards the Freenome data or maybe the quality in the past. And that's certainly -- obviously, it's changed now.
太好了,謝謝。我在這裡回答這些問題。也許只是多夥伴。我認為在過去,我的印像是確切的團隊可能對 Freenome 數據或過去的品質持懷疑態度。顯然,現在已經改變了。
But I guess the question would be kind of what can you say about your team's confidence in like the clinical study rigor and performance status such that you believe it will allow for FDA approval? And then the second part was related just to the headline data itself that was in the press release, the 81 and the 14 and the 90. I know in the publication, it was a bit lower than that. I think it's age adjusted.
但我想問題應該是,您能說說您的團隊對臨床研究嚴謹性和表現狀態的信心嗎,以至於您認為它將獲得 FDA 批准?第二部分僅與新聞稿中的標題資料本身有關,即 81、14 和 90。我知道在出版物中,這個數字要比這低一點。我認為它是根據年齡調整的。
So is that the appropriate way to look at it on age adjusted. And then final point would be, given you're so dominant in stool, although the blood market is nascent, would you envision any FTC issues with this deal? Thank you.
那麼,這是根據年齡調整來看待這個問題的適當方式嗎?最後一點是,鑑於你們在糞便領域佔據主導地位,儘管血液市場尚處於萌芽階段,您是否認為這筆交易會引發任何联邦貿易委員會 (FTC) 問題?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
On the last point, we believe that this is a deal that should make it through an HSR review. Obviously, there's a process there that will play out. In terms of the performance of the test, yes, on an age-adjusted basis, which is the approach that the FDA and Freenome have worked on.
關於最後一點,我們認為這項協議應該通過高鐵審查。顯然,這是一個需要完成的過程。就測試表現而言,是的,基於年齡調整,這是 FDA 和 Freenome 一直致力於的方法。
And again, I'm not making any comments. It is their submission, and we will benefit from it, but [81, 14, 90], in terms of the diligence that we did, we're very impressed with the actual study design, the data, the rigor that the study that they designed and the performance of the test, which has been now validated.
我再說一遍,我不會發表任何評論。這是他們提交的研究,我們會從中受益,但[81, 14, 90],就我們所做的努力而言,我們對實際的研究設計、數據、他們設計的研究的嚴謹性以及測試的性能印象深刻,這些都已經得到驗證。
Just one other comment. The new leadership, Aaron Elliott, is a real strong addition to the team. I would say, adding Aaron to that team really made it quite a positive for us to enter into this agreement. And so all of our interactions with them have been quite positive, and we've been impressed.
還有一則評論。新領導層 Aaron Elliott 對團隊來說是一個真正強大的補充。我想說,將亞倫加入該團隊確實對我們達成這項協議有很大幫助。因此,我們與他們的所有互動都非常積極,並且給我們留下了深刻的印象。
Operator
Operator
Dan Arias, Stifel.
丹·阿里亞斯(Dan Arias),Stifel。
Daniel Arias - Analyst
Daniel Arias - Analyst
Afternoon guys. Thanks for the questions. Kevin, I understand that science is not linear, but the team is definitely bullish multiple times in a way that people just really couldn't understand last year. So can you offer something on what your R&D folks have concluded or what the thesis was that didn't play out?
大家下午好。感謝您的提問。凱文,我明白科學不是線性的,但去年球隊確實多次表現出樂觀的態度,這是人們無法理解的。那麼,您能否介紹一下您的研發人員得出了什麼結論,或者有哪些論點沒有得到證實?
I mean it sounds like we have a sort of a long road ahead of us when it comes to just asking what performance needs to be in MRD or in MSD in order to be relevant. So it just seems like asking what happened versus what you thought would happen is a fair question.
我的意思是,聽起來,當我們要問 MRD 或 MSD 需要達到什麼樣的表現才能具有相關性時,我們還有很長的路要走。因此,詢問實際發生了什麼而不是您認為會發生什麼似乎是一個公平的問題。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Well, let me take you back to Cologuard Plus, which is a three-marker methylation marker test plus protein, we delivered and the R&D team, same R&D team delivered unbelievable performance with Cologuard Plus, which was a significant investment, which we think will have a massive ROI.
好吧,讓我帶您回到 Cologuard Plus,這是一種三標記甲基化標記測試加蛋白質,我們和研發團隊,同一個研發團隊透過 Cologuard Plus 實現了令人難以置信的性能,這是一項重大投資,我們認為它將獲得巨大的投資回報。
I think starting with patient ROI, just with the 40% improvement in Cologuard Plus specificity, that could lead over the next 30 years to about $1 billion of saving in terms of reduced colonoscopy. So the R&D team has done a tremendous job.
我認為從患者的投資回報率開始,僅 Cologuard Plus 特異性提高 40%,就可能在未來 30 年內透過減少大腸鏡檢查節省約 10 億美元。所以研發團隊做了大量的工作。
Our blood test is a -- that we ran as part of this study was three methylation markers on kind of advanced, what we call, talk is PCR-based platform that we missed the mark. Now remember, you are dealing with a lot of small numbers.
作為這項研究的一部分,我們進行的血液檢查是三種甲基化標記,我們稱之為基於 PCR 的平台,但我們沒有達到目標。現在請記住,您正在處理很多小數字。
In terms of the actual performance difference, when you look statistically, there's not a significant difference here between the various tests that are in market. . But we didn't hit the endpoint. So I do understand the frustration, and we own that.
就實際效能差異而言,從統計數據來看,市場上的各種測試之間並沒有顯著差異。。但我們並未到達終點。所以我確實理解這種挫敗感,這是我們的責任。
And all I can say is our -- I would never bet against our R&D team and that program will continue. It's just not the right time for us to dig into those details because, number one, we just licensed a great test. And two, we are still submitting to the FDA, so there's more work to be done there.
我只能說,我絕對不會輸給研發團隊,而且該計劃將繼續下去。現在還不是我們深入研究這些細節的正確時機,因為首先,我們剛剛批准了一個很棒的測試。其次,我們仍在向 FDA 提交申請,因此還有更多工作要做。
Operator
Operator
Puneet Souda, Leerink Partners.
Puneet Souda,Leerink 合夥人。
Puneet Souda - Analyst
Puneet Souda - Analyst
Yeah, hi, Kevin, I would just want to go back a bit. You've always appreciated and invested into technology development. Obviously, blood is a hard problem to crack. But given where you stand today, do you think this assay that you're acquiring or your own efforts can match what the competition can continue to improve on? And then my second question is, what do you think is the -- was going to be the market share for blood-based testing in this multimodal market?
是的,嗨,凱文,我只是想回顧一下。您一直重視並投資於技術開發。顯然,血液是一個很難解決的問題。但是考慮到您目前的狀況,您認為您獲得的這項檢測或您自己的努力能夠與競爭對手不斷改進的檢測相媲美嗎?我的第二個問題是,您認為在這個多模式市場中,血液檢測的市場佔有率是多少?
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Let me start with the last question first. I think over time, you may see about 5% to 10% of the market being blood. USPSTF, the guideline group will play a very critical role with the current modeling and the current performance of blood tech, you're just not at the point that what these current versions of blood test probably pass muster and get rated A or B by USPSTF, why? While these blood tests are just slightly better than blind to precancerous polyps and precancerous polyps drive about two-thirds of the positive impact from screening in this field.
我先從最後一個問題開始。我認為隨著時間的推移,你可能會看到大約 5% 到 10% 的市場是血腥的。USPSTF 指南小組將在當前的建模和血液技術的當前性能方面發揮非常關鍵的作用,您還沒有達到這些當前版本的血液測試可能通過審查並獲得 USPSTF 評級 A 或 B 的程度,為什麼?雖然這些血液檢測對癌前息肉的盲測僅略勝一籌,但癌前息肉約佔該領域篩檢的三分之二的正面影響。
So that's critically important. And then you couple that with a 10% false positive rate, and it leads to low impact at three-year intervals and relatively kind of a medium impact in terms of unnecessary colonoscopies. If you run it as a one-year interval, you get better impact, but at a steep cost.
所以這至關重要。然後再加上 10% 的假陽性率,這會導致三年間隔內的影響較低,並且在不必要的大腸鏡檢查方面的影響相對較中等。如果以一年為間隔運行,則會獲得更好的效果,但成本較高。
So it's somewhere between the efficient frontier where Cologuard and colonoscopy are and no screening at all. It's somewhere in the middle. Does that get an A or B rated test? It's hard to see that with the current performance.
因此,它處於 Cologuard 和大腸鏡檢查的有效邊界與完全無篩檢之間。它位於中間某處。這會得到 A 或 B 級測試嗎?從目前的表現來看,很難看到這一點。
If you're not in USPSTF guidelines, you're not in the quality measures, if you're not on the quality measures, commercial payers aren't going to rush to cover the test. We saw that with Cologuard we're currently seeing that play out with blood-based testing. So is there a role? Yes. Medicare will pay for those tests.
如果您不符合 USPSTF 指南,您將不符合品質衡量標準,如果您不符合品質衡量標準,商業付款人就不會急於支付測試費用。我們看到,透過 Cologuard,我們目前看到了基於血液的檢測正在發揮作用。那麼有作用嗎?是的。醫療保險將支付這些測試的費用。
And Medicare is a portion of the market. But that performance delta is a real issue. We've been saying this for a long time. I think you're seeing that play out today in the market. which is 99.5% Cologuard and 0.5% blood-based CRC screening.
醫療保險是市場的一部分。但性能差異確實是一個問題。我們已經說這個很久了。我認為您今天在市場上看到的是這種情況。其中 99.5% 是 Cologuard,0.5% 是基於血液的 CRC 篩檢。
Will that change over time? We'll see. In large part, it depends upon the guidelines. So where we -- do we think Freenome's tell can match others into the future? That depends the version 2 data that we've seen, again, we built into the agreement that if their Version 2 doesn't deliver more than 19%, we can get out of the agreement and pivot to our own program.
隨著時間的推移,這種情況會改變嗎?我們將拭目以待。在很大程度上,這取決於指導方針。那麼,我們是否認為 Freenome 的預測在未來能夠與其他人匹敵?這取決於我們看到的版本 2 數據,同樣,我們在協議中規定,如果他們的版本 2 的交付率不超過 19%,我們就可以退出協議並轉向我們自己的計劃。
So it's -- nobody has delivered Version 2. We have a program, Freenome has a program. Others have programs, and we'll see where that plays out.
所以——沒有人交付第 2 版。我們有一個程序,Freenome 也有一個程序。其他人也有計劃,我們將看看其結果如何。
Operator
Operator
Michael Ryskin, Bank of America.
美國銀行的邁克爾·里斯金(Michael Ryskin)。
Michael Ryskin - Analyst
Michael Ryskin - Analyst
Thanks, second question, Kevin. I want to follow up on that was just kind of asked I realize there's a Version 1 and a Version 2. So there's going to be different considerations for both. But your earlier comment on you seeing having blood taking 5% to 10% of the market and how this compares to shield.
謝謝,第二個問題,凱文。我想跟進一下這個問題,我意識到有版本 1 和版本 2。因此,兩者會有不同的考量。但是您之前評論說血液佔據了 5% 到 10% 的市場份額,並且與盾牌相比如何。
Just -- as we layer this into our model over the next couple of years, how should we think about what this could do to the exact model? Should we use Shield as a benchmark in terms of volume and revenue ramp and just sort of theirs the pros and cons of the lower sensitivity versus having your commercial engine and your market presence?
只是——當我們在未來幾年將其融入我們的模型時,我們應該如何思考這會對確切的模型產生什麼影響?我們是否應該使用 Shield 作為銷售和收入成長的基準,以及它們與商業引擎和市場存在相比較低靈敏度的利弊?
Just what's the right way to think about how you think volumes and revenue share could grow over time? Thanks.
那麼,您認為銷售量和收入份額如何隨著時間的推移而增長,正確的思考方式是什麼?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Yeah. I think the right way -- thanks for the question. I think the right way to look at this is actually different than probably s -- some s are thinking about this right now. Start with the Cologuard brand. The brand awareness now is greater than colonoscopy in five of the last six months.
是的。我認為這是正確方法——感謝您的提問。我認為看待這個問題的正確方式實際上與某些人現在正在思考這個問題的方式不同。從 Cologuard 品牌開始。目前,該品牌的知名度在過去六個月中有五個月都高於大腸鏡檢查。
The power of that brand means that not only are patients asking for Cologuard but physicians are recommending Cologuard first even ahead of colonoscopy. And then when you add more reps into the field talking about colon cancer screening, that feeds more Cologuard and now Cologuard Plus growth. And that's what we're actually seeing in the market is that there is a -- and we believe we'll see this if you look out over the next five years, even more of those 55 million unscreened people are going to get screened.
該品牌的力量意味著不僅患者要求使用 Cologuard,而且醫生甚至在結腸鏡檢查之前就首先推薦使用 Cologuard。然後,當您在該領域增加更多代表來談論結腸癌篩檢時,這將促進 Cologuard 和現在的 Cologuard Plus 的成長。這就是我們在市場上實際看到的情況——我們相信,如果你關注未來五年,我們就會看到這一點,5500 萬未接受篩檢的人中將有更多的人接受篩檢。
Now when you think about that, this year approximately somewhere in the range plus or minus of 5 million people get screened with Cologuard and roughly 6 million people with colonoscopy. As you look over time, there's a tipping point where Cologuard not too far from the future is used more often than screening colonoscopy. And so we think that continues and more reps in this field probably ends up a rising tide lifts all boats.
現在想想,今年大約有 500 萬人接受了 Cologuard 篩檢,大約有 600 萬人接受了大腸鏡檢查。隨著時間的推移,我們會發現在不久的將來,Cologuard 的使用頻率將超過篩檢大腸鏡檢查。因此,我們認為,這一領域的持續發展和更多的代表可能最終會使水漲船高。
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Then Michael, specifically from a modeling perspective on the blood as well. Keep in mind, like so as Kevin said, we're not going to opine as to exactly when FDA approval would come. But once we have that, it's going to be additive. To our overall revenue and to our overall growth rates. We view this again as additive to our portfolio, additive to our long-term revenue growth and additive to the strong financial profile that we've established.
然後邁克爾,具體從建模的角度來談談血液。請記住,就像凱文所說的那樣,我們不會對 FDA 批准的具體時間發表意見。但一旦我們有了它,它就會具有附加作用。對我們的整體收入和整體成長率而言。我們再次認為這會增強我們的投資組合、增強我們的長期收入成長、增強我們已經建立的強勁財務狀況。
Operator
Operator
Patrick Donnelly, Citi. Please go ahead.
花旗銀行的 Patrick Donnelly。請繼續。
Patrick Donnelly - Analyst
Patrick Donnelly - Analyst
Hey guys, thanks for the question. Kevin, maybe just on the internal program. I know you talked about the additional market not being included. Can you just talk about the go forward there, what the investments are going to look like on that piece, now that you have this Freenome option as well.
嘿夥計們,謝謝你的提問。凱文,也許只是內部計劃。我知道您談到了未包括的附加市場。你能不能談談未來的發展,現在你也有了這個 Freenome 選項,那部分的投資將會是什麼樣的。
And then just quickly on Freenome, I know to the earlier question, to be around in the past. But on the time lines drag out, given the submission of the FDA drag. Can you just talk about what that the confidence and the data there would be helpful. Thank you guys.
然後快速地談論一下 Freenome,我知道之前的問題,這個問題在過去就存在了。但由於 FDA 提交的申請,時間安排被拖延了。您能否談談信心和數據有何幫助?謝謝你們。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Patrick, you cut out on the second part of your question. Was it confidence around time lines?
派崔克,你切斷了問題的第二部分。是對於時間線的信心嗎?
Patrick Donnelly - Analyst
Patrick Donnelly - Analyst
Yes. Just the time line, again, I know the FDA submission time line dragged out a little bit with Freenome. So I just wanted to talk through what caused that and what got you comfortable there? Thank you.
是的。只是時間線,再說一次,我知道 FDA 提交的時間線與 Freenome 一起拖延了一點。所以我只是想談談是什麼原因導致了這種情況以及是什麼讓您感到舒適?謝謝。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
A lot of work goes into a PMA submission. And we're a smaller company, it's just a huge effort, and we looked at every one of their modules and the quality of work they did is very high. And so we believe that there are no major issues in terms of their submission and our confidence level aside, which is why we entered into this.
PMA 提交需要做大量的工作。我們是一家規模較小的公司,需要付出巨大的努力,我們研究了他們的每一個模組,他們所做的工作品質非常高。因此,我們認為,除了他們的提交和我們的信心水平之外,不存在重大問題,這就是我們參與此事的原因。
In terms of our current program strategy going forward, again, we're not going to get into those details. We have exclusively licensed a well-performing test with an option to potentially an even better performing test and we look forward to deploying that. We will really put our back into that program, and we're excited about it. We think that we're in the natural position to have the biggest impact in this field.
就我們目前未來的計劃策略而言,我們不會深入討論這些細節。我們已經獨家授權了一項性能良好的測試,並且可以選擇性能甚至更好的測試,我們期待部署它。我們將全力投入到該計劃中,我們對此感到非常興奮。我們認為,我們自然而然地會在這個領域產生最大的影響。
Operator
Operator
Eve Burstein, Bernstein.
伊芙·伯斯坦,伯恩斯坦。
Eve Burstein - Equity Analyst
Eve Burstein - Equity Analyst
Great, thank you so much for taking the question. One thing that you seem to be giving up in this licensing deal at Freenome is potentially some of the moat around your multi-cancer test. So for example, in Freenome's press release, they noted that they will have access to all multimodal data from colorectal cancer screening patients to power future AI and ML models across multiple cancer indications.
太好了,非常感謝您回答這個問題。在與 Freenome 的許可協議中,你們似乎放棄了一項可能圍繞多癌症測試的護城河。例如,在 Freenome 的新聞稿中,他們指出他們將能夠存取結直腸癌篩檢患者的所有多模式數據,為未來多種癌症適應症的 AI 和 ML 模型提供支援。
And they were even quoted as saying the partnership gives them real-world data they need to improve their existing tests and accelerate development of the multi-cancer test in their pipeline. So from these points, I take away the fact that Freenome wants to lean really hard into their multi-cancer screening test, and you're giving them a platform to improve their product. which will ultimately compete with your test. So what made you agree to this term in the agreement? And how do you see this choice impacting sales of your own test?
他們甚至表示,此次合作為他們提供了所需的真實數據,以改進他們現有的測試並加速其多癌症測試的開發。因此,從這些觀點來看,我認為 Freenome 想要大力發展他們的多癌症篩檢測試,而你為他們提供了一個改進產品的平台,最終將與你的測試競爭。那麼是什麼讓您同意協議中的這個條款呢?您認為這個選擇對你們測試的銷售有何影響?
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Sure. We'll be launching our multi-cancer screening test through a field force of about 1,000 people next month. We couldn't be more excited about it. It's a tremendous opportunity to have a huge impact on human health over time.
當然。下個月,我們將透過約 1,000 人的實地工作團隊啟動多癌症篩檢測試。我們對此感到無比興奮。這是一個巨大的機會,可以長期對人類健康產生巨大的影響。
There's no company that has the reach, the customer reach, the sales reach the global reach, so we get to lever off of our incredible reach through the Genomic Health and Oncotype DX reach. We intend to launch also globally in select markets. So in terms of the deal with Freenome, look, they have their own program, and we'll compete quite vigorously there. We have the commercial organization.
沒有任何一家公司擁有如此大的覆蓋範圍、客戶覆蓋範圍和銷售覆蓋範圍,因此,我們可以透過 Genomic Health 和 Oncotype DX 的覆蓋範圍來發揮我們驚人的覆蓋範圍。我們也打算在全球特定市場推出該產品。因此,就與 Freenome 的交易而言,他們有自己的計劃,我們將在那裡展開激烈的競爭。我們有商業組織。
In terms of data and access to data, to the extent that they do get data, whether that really helps them develop the test. Remember, you need to have the patient characterization, not just the raw data. The raw data itself, without understanding whether the patient has cancer or doesn't have cancer does not, in our experience, provide you with tremendous ability to do product development. We really need to have characterized samples to be able to do that.
就數據和數據存取而言,就他們獲得的數據而言,這是否真的有助於他們開發測試。請記住,您需要了解患者的特徵,而不僅僅是原始數據。根據我們的經驗,如果不知道患者是否患有癌症,那麼原始數據本身並不能為您提供強大的產品開發能力。我們確實需要有特徵樣本才能做到這一點。
So that's all I'll comment out there. We are -- we will be licensing their technology and competing with them. We think that's a positive thing for patients over time because more investments in this field. usually ends up being good for patients.
這就是我要評論的全部內容。我們將授權他們的技術並與他們競爭。我們認為從長遠來看這對患者來說是一件好事,因為在該領域進行更多的投資通常最終會對患者有利。
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
Hi Kevin. Thank you for taking my question. Regarding the additional biomarker, I'm unclear why they weren't included in the readout. Can you clarify? And this the fact that you went after Freenome, does that tell that you don't have the confidence that the biomarker will take you to an acceptable sensitivity level?
你好,凱文。感謝您回答我的問題。關於額外的生物標誌物,我不清楚為什麼它們沒有被包括在讀數中。你能解釋一下嗎?事實上,您選擇 Freenome 是否表明您對生物標記能否達到可接受的敏感度水平沒有信心?
And does that say something to your performance for the insides given it's a PCR-based approach many of us, including me, have wondered if PCR could ever perform at the level of NGS. Does this answer that question for class of assays?
鑑於它是一種基於 PCR 的方法,這是否說明了您在內部表現方面的表現?我們中的許多人(包括我)都想知道 PCR 是否能夠達到 NGS 的水平。這是否回答了有關分析類別的問題?
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
For the second part of your question, I would go back and point to Cologuard Plus. Again, because we approach the scientific part of our platform by first identifying the most discriminatory markers and working backwards.
對於您問題的第二部分,我想回顧並指出 Cologuard Plus。再次,因為我們透過首先識別最具歧視性的標記並逆向工作來處理我們平台的科學部分。
That's why we were able to develop a test with 95% sensitivity and 94% specificity on a platform that allows us to reach millions of people in a way that allows us to make significant investments. And our MSET data, which is a combination of our talks platform and the Thrive technology also delivers a high level of sensitivity.
這就是為什麼我們能夠在一個平台上開發出敏感性為 95%、特異性為 94% 的測試,該平台使我們能夠以一種允許我們進行大量投資的方式接觸數百萬人。我們的 MSET 數據是我們的會談平台和 Thrive 技術的結合,也具有高水準的靈敏度。
So Again, I'm not going to get into the areas where we believe that we learned, and this is an important thing. We learned a lot with this three marker approach that we -- this three methylation marker plus one protein approach, and we think that those learnings will fuel improvements to our platform now and in the future, it stings, no doubt. However, we think that it will make us better in the future, and I have enormous confidence in our R&D team.
所以,我再說一遍,我不會深入討論我們認為已經學到的東西,這是一件重要的事情。我們透過這三種標記方法學到了很多東西——三種甲基化標記加一種蛋白質的方法,我們認為這些經驗將推動我們現在和將來平台的改進,毫無疑問,這是有意義的。但是,我們認為這會讓我們未來變得更好,我對我們的研發團隊充滿信心。
Again, I will point right to Cologuard Plus, which has delivered over a couple of hundred thousand results I'm looking around at the team right now, and that will grow quickly now with Humana and Centene adopting. So I understand why some may be disappointed. So are we. You've got to look at the same technology platform that has delivered incredible results in the past.
再次,我將直接指出 Cologuard Plus,它已經產生了數十萬個結果,我現在正在團隊中查看,隨著 Humana 和 Centene 的採用,它將迅速增長。所以我理解為什麼有些人可能會感到失望。我們也是。您必須看看過去曾帶來令人難以置信的成果的同一技術平台。
Operator
Operator
Luke Sergott, Barclays.
巴克萊銀行的盧克‧塞戈特 (Luke Sergott)。
Luke Sergott - Analyst
Luke Sergott - Analyst
Great, thanks. I just wanted to follow up on that. Is that the couple of hundred thousand CG plus that you guys have offered? Is that -- I mean, what do you guys end up doing in the quarters as you're thinking about the ramp here from what's embedded in the guide for the back half? And how the progress there from a conversion standpoint?
太好了,謝謝。我只是想跟進一下這一點。這就是你們提供的幾十萬 CG 加價嗎?那是——我的意思是,當你們根據後半部分的指南中的內容來考慮這裡的坡道時,你們最終在四分之一決賽中做了什麼?從轉換的角度來看,進展如何?
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Aaron Bloomer - Chief Financial Officer, Executive Vice President
Thanks, Luke. Progress is going really well. From a launch perspective, we started out in at launch with just the Medicare fee-for-service. And as we've said, that's about 10% to 15% of our patient volume in any given month and quarter, and that is what we saw in Q2. The other thing from a launch perspective that we're seeing is it's driving increased access for our reps with physicians, which is very important for broader Cologuard growth.
謝謝,盧克。進展非常順利。從發布的角度來看,我們在發佈時僅採用了醫療保險按服務收費的方式。正如我們所說,這大約占我們任何月份和每個季度患者數量的 10% 到 15%,這就是我們在第二季度看到的情況。從發布的角度來看,我們看到的另一件事是它正在增加我們的代表與醫生的接觸機會,這對於更廣泛的 Cologuard 發展非常重要。
On the payer side, conversations have been really productive. We announced -- obviously, now we have 2 of the top 10 payers, which will start to come online with Cologuard Plus here into the back half of the year.
在付款方,對話確實富有成效。我們宣布——顯然,現在我們有 2 家排名前 10 位的付款人,他們將在今年下半年開始使用 Cologuard Plus。
And we're obviously really excited about that. We are not coming off our commitment to -- that this will take 12 to 18 months we will be sunsetting at some point in time because we feel we have a responsibility to bring the best test to patients.
我們顯然對此感到非常興奮。我們不會放棄承諾——這將需要 12 到 18 個月的時間,我們將在某個時間點停止,因為我們覺得我們有責任為患者提供最好的測試。
We haven't set a specific date just yet, but we will be sunsetting and obviously, the team is making just tremendous progress. I'd close by just thanking our lab and our entire operational team that's just done a phenomenal job of ensuring that we can bring our Cologuard and Cologuard Plus test results to patients in a seamless way.
我們還沒有確定具體的日期,但我們將會停止,顯然,團隊正在取得巨大的進步。最後,我要感謝我們的實驗室和整個營運團隊,他們出色地完成了工作,確保我們能夠以無縫的方式將 Cologuard 和 Cologuard Plus 測試結果帶給患者。
Operator
Operator
This concludes our question-and-answer session. I will now turn the call back over to Kevin Conroy for closing remarks.
我們的問答環節到此結束。現在我將把電話轉回給凱文康羅伊,請他作最後發言。
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Kevin Conroy - Chairman of the Board, President, Chief Executive Officer
Thank you all for joining us today. We look forward to sharing our progress throughout this transformational time at Exact Sciences as we became a one-stop solution for comprehensive genomic testing. Most importantly, thanks to the dedicated team at Exact Sciences for their commitment to our purpose of eradicating cancer. Thank you.
感謝大家今天的參與。我們期待在 Exact Sciences 轉型期間分享我們的進步,因為我們已成為全面基因組測試的一站式解決方案。最重要的是,感謝 Exact Sciences 的專業團隊對我們消滅癌症目標的承諾。謝謝。
Operator
Operator
Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.
女士們、先生們,今天的電話會議到此結束。感謝大家的加入。您現在可以斷開連線。