This study was a prospective analysis conducted by Geneoscopy Inc. to evaluate the ColoSense test, which is a multi-target stool RNA test for colorectal cancer screening.

开始日期2021-04-12

申办/合作机构

Geneoscopy, Inc.初创企业

100 项与 Geneoscopy, Inc. 相关的临床结果

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0 项与 Geneoscopy, Inc. 相关的专利（医药）

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项与 Geneoscopy, Inc. 相关的文献（医药）

2024-08-01·JOURNAL OF MOLECULAR DIAGNOSTICS

Analytical Validation of the Multitarget Stool RNA Test for Colorectal Cancer Screening

Article

作者: Grass, Clayton ; Wurtzler, Elizabeth M ; Scott, Maya C ; Land, Jack ; Barnell, Erica K ; Morrison, Catherine ; Duncavage, Eric J ; Wedeking, Ben ; Zuniga, Ann ; Kruse, Kimberly

The multitarget stool RNA (mt-sRNA) test (ColoSense) is a noninvasive diagnostic test that screens for colorectal cancer and advanced adenomas in average-risk individuals aged 45 years and older. The mt-sRNA test incorporates a commercially available fecal immunochemical test, concentration of eight RNA transcripts, and participant-reported smoking status. As part of the CRC-PREVENT (Colorectal Cancer and Pre-Cancerous Adenoma Non-Invasive Detection Test) clinical trial, 12 analytical validation studies were conducted to assess analytical sensitivity, linearity, precision, interfering substances, cross-reactivity, carry-over, cross-contamination, and robustness. Analytical validation of the mt-sRNA test demonstrated limit of blank, limit of detection, and limit of quantification of <0.6, <0.7, and ≤2.5 copies/μL for all markers, respectively. The mt-sRNA test demonstrated linearity between 2.5 and 2500 copies/μL, and <20% coefficient of variation, and/or ≥95% concordance with regard to precision, interfering substances, carry-over, cross-contamination, and robustness. There was no significant impact of cross-reactivity from non-colorectal cancer diseases. These data provide a framework for laboratories to complete analytical validation for RNA-based panels that require premarket approval as a class III medical device from the US Food and Drug Administration.

2023-11-14·JAMA

Multitarget Stool RNA Test for Colorectal Cancer Screening

Article

作者: Wurtzler, Elizabeth M ; Hao, Yansheng ; Holmes, Faith L ; La Rocca, Julie ; Barnell, Erica K ; Kang, Yiming ; Petrone, Jessica ; Fitzgerald, Thomas ; Lieberman, David A

Importance:

Noninvasive tests for colorectal cancer screening must include sensitive detection of colorectal cancer and precancerous lesions. These tests must be validated for the intended-use population, which includes average-risk individuals 45 years or older.

Objective:

To evaluate the sensitivity and specificity of a noninvasive, multitarget stool RNA (mt-sRNA) test (ColoSense) test compared with results from a colonoscopy.

Design, Setting, and Participants:

This phase 3 clinical trial (CRC-PREVENT) was a blinded, prospective, cross-sectional study to support a premarket approval application for a class III medical device. A total of 8920 participants were identified online using social media platforms and enrolled from June 2021 to June 2022 using a decentralized nurse call center. All participants completed the mt-sRNA test, which incorporated a commercially available fecal immunochemical test (FIT), concentration of 8 RNA transcripts, and participant-reported smoking status. Stool samples were collected prior to participants completing a colonoscopy at their local endoscopy center. The mt-sRNA test results (positive or negative) were compared with index lesions observed on colonoscopy. Over the course of 12 months, individuals 45 years and older were enrolled in the clinical trial using the decentralized recruitment strategy. Participants were enrolled from 49 US states and obtained colonoscopies at more than 3800 different endoscopy centers.

Main Outcomes and Measures:

The primary outcomes included the sensitivity of the mt-sRNA test for detecting colorectal cancer and advanced adenomas and the specificity for no lesions on colonoscopy.

Results:

The mean (range) age of participants was 55 (45-90) years, with 4% self-identified as Asian, 11% as Black, and 7% as Hispanic. Of the 8920 eligible participants, 36 (0.40%) had colorectal cancer and 606 (6.8%) had advanced adenomas. The mt-sRNA test sensitivity for detecting colorectal cancer was 94%, sensitivity for detecting advanced adenomas was 46%, and specificity for no lesions on colonoscopy was 88%. The mt-sRNA test showed significant improvement in sensitivity for colorectal cancer (94% vs 78%; McNemar P = .01) and advanced adenomas (46% vs 29%; McNemar P &lt; .001) compared with results of the FIT.

Conclusions and Relevance:

In individuals 45 years and older, the mt-sRNA test showed high sensitivity for colorectal neoplasia (colorectal cancer and advanced adenoma) with significant improvement in sensitivity relative to the FIT. Specificity for no lesions on colonoscopy was comparable to existing molecular diagnostic tests.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04739722

Clinical and translational gastroenterology2区 · 医学

Multitarget Stool RNA Test for Noninvasive Detection of Colorectal Neoplasia in a Multicenter, Prospective, and Retrospective Cohort

2区 · 医学

ArticleOA

作者: Griffith, Obi L. ; Barnell, Erica K. ; Barnell, Andrew R. ; Wurtzler, Elizabeth M. ; Chaudhuri, Aadel A. ; Khan, Adnan R. ; Fiske, Jared ; Kruse, Kimberly R. ; Griffith, Malachi ; Huebner, Thomas A. ; Holmes, Faith L. ; Pittz, Zachary R. ; Kang, Yiming

INTRODUCTION::

Effective colorectal cancer (CRC) prevention and screening requires sensitive detection of all advanced neoplasias (CRC and advanced adenomas [AA]). However, existing noninvasive screening approaches cannot accurately detect adenomas with high sensitivity.

METHODS::

Here, we describe a multifactor assay (RNA-FIT test) that combines 8 stool-derived eukaryotic RNA biomarkers, patient demographic information (smoking status), and a fecal immunochemical test (FIT) to sensitively detect advanced colorectal neoplasias and other non-advanced adenomas in a 1,305-patient, average-risk, prospective cohort. This cohort was supplemented with a 22-patient retrospective cohort consisting of stool samples obtained from patients diagnosed with AA or CRC before treatment or resection. Participants within these cohorts were evaluated with the RNA-FIT assay and an optical colonoscopy. RNA-FIT test results were compared with colonoscopy findings.

RESULTS::

Model performance was assessed through 5-fold internal cross-validation of the training set (n = 939) and by using the model on a hold out testing set (n = 388). When used on the hold out testing set, the RNA-FIT test attained a 95% sensitivity for CRC (n = 22), 62% sensitivity for AA (n = 52), 25% sensitivity for other non-AA (n = 139), 80% specificity for hyperplastic polyps (n = 74), and 85% specificity for no findings on a colonoscopy (n = 101).

DISCUSSION::

The RNA-FIT assay demonstrated clinically relevant detection of all grades of colorectal neoplasia, including carcinomas, AAs, and ONAs. This assay could represent a noninvasive option to screen for both CRC and precancerous adenomas.

项与 Geneoscopy, Inc. 相关的新闻（医药）

2024-11-27

·循因缉药

Cologuard 2.0：我们的医保很有钱呀

环球视野，深度视角各位亲爱的股东，大家早上好中午好晚上好。 2024年11月26日，肠癌早筛的扛把子Exact Sciences股价表现活跃，截至收盘上涨9%。据悉，周一刚刚结束的CMS（Centers for Medicare and Medicaid Services） 2025临床实验是费用计划已经确定。本次给于Cologuard Plus，也就是第二代Cologuard 肠癌早筛的报销价格是592美元。 Exact Sciences当初希望得到的方案是635美元，或者是1.25倍Cologuard 1.0的价格（508美元）。这价格是根据这个公式来的： Cologuard Plus = Septin9（192美元）*3+FIT检测（15美元）你甭管为啥是这么算，只要比原来的价格高就行呗。美国医保还是有钱啊。不过，在翻CMS的这份清单的时候，发现了一个好玩的事情。 GeneoScopy的Colosense纳入报销，定价参考原来的Cologuard定价，也就是509美元。更为神奇的是 Singlera Genomic 的ColonAiQ也被纳入了报销，参考Septin 9检测价格，也就是192美元。 Singlera Genomic是谁？他有一个我们更为熟悉的名字：鹍远生物。 ColonAiQ在国内的名字是：常艾克，2024年5月14日中国获批。目前，ColonAiQ并未在美国获得IVD证，应该以LDT形式运行。当然，这里面的价格都是根据有限的信息推断出来的，美国医保里面的报销价格实在是看的眼花缭乱，具体如何去算欢迎评论区大佬指正。另外，据悉Exact Sciences还在跟商保谈判，争取更高的报销价格。话说，商保要不要看看ColonAiQ，让资本主义感受下我们的正义铁拳。最后，我好像忘了跟大家说，Exact Sciences的Cologuard 3.0已经是进行时了。呃，本来应该Q1的时候跟大家汇报，写着写着忘了... END 啊对对对对，扫描这货能联系到我至此，各位股东星标了么？点赞了么？转发了么？在看了么？谢谢！所有内容均不作为投资建议，信息均来自公开资料。 PS：《黑金》那张图我觉得可以一直用... 近期文章： Guardant Health等来的正义：2.925亿美元蛋白测序明星裁员23% 安捷伦Agilent事业群重磅重组！ Twist：拜托了，总统先生药明康德2024Q3：离不开美国，美国也离不开相关资料：注1：https://www.genomeweb.com/reimbursement-news/exact-sciences-shares-rise-unexpected-reimbursement-rate-cms-next-gen-cologuard注2：https://finance.yahoo.com/news/why-exact-sciences-stock-trading-172115662.html

2024-11-09

·氨基观察

肿瘤早筛一哥的“信任裂痕”

氨基观察-医疗器械组原创出品作者 | 迪熊过去十年，精密科学的结直肠癌早筛产品Cologuard讲述了一个开放式的增长故事。持续的增长，也让Cologuard成为了结肠癌筛查的代名词。不过，随着增长年头已经超过十年之后，Cologuard还能继续吗？肯定的声音不少，但摇摆的情绪也开始出现。 11月6日，精密科学交出了一份不错的三季报。第三季度，精密科学总收入达到7.07亿美元，同比增长13%；其中，最为核心的筛查业务收入为5.45亿美元，同比增速达到了15%。尽管增速仍然可观，但精密科学却下调了全年的收入指引，筛查业务收入规模较预期减少7800万美金，该业务全年收入上限为20.95亿美金。这意味着，第四季度环比将会出现下降的情况。对此，精密科学极力将原因归于特例：飓风的影响，导致了今年销售额的不及预期。并且，精密科学一再强调后续的增长仍然可以持续。但华尔街却选择了用脚投票：财报发布当天，精密科学股价跌幅达23.48%，市值蒸发超30亿美金。 / 01 / 信心十足的管理层面对Cologuard收入下调的预期，精密科学管理层一再强调：困难只是暂时的。之所以下调业绩，是因为飓风影响了大约Cologuard 群体的18%。因此，这会导致第四季度业绩遭遇挑战。在电话会议中，管理层对于未来几年的业绩仍然信心十足，认为2027年实现收入增长15%、调整后 EBITDA 利润率超过20%的目标不变。支撑这一预期的关键在于，结直肠癌早筛产品的增长远未结束。管理层的乐观，来自于多个维度。首先，公司的基本盘非常稳固。目前，公司与近25万家机构建立了紧密的联系，持续挖掘这些机构的需求，会带来增量。其次，Cologuard Plus将在明年二季度推出，驱动进一步的增长。相较于Cologuard，Plus版本的性能得到进一步提升，公司认为一方面这会收获更多消费者的认可，另一方面能够通过更高的价格获得业绩增量。另外，结直肠癌早筛的复购规模在继续提升。随着使用群体的增加，需要复购的消费者规模也会随之提升。在精密科学的测算中，今年大约新增160万人进入复购周期，2026年这一数字会增加至260万。对应的，2025年的复购规模，至少达到130万。最后，渗透率提升的逻辑还在。在美国，肠镜资源不足、依从性不高且价格昂贵，因此Cologuard具备作为前置性筛查工具的机会。精密科学认为，鉴于肠镜使用的种种挑战，支付方会加大对Colguard的支持力度，美国还有6000万人没有得到有效满足，这自然是其潜在增长动力。不过，对于管理层的这套说辞，投资者并不买账。 / 02 / 华尔街的焦虑华尔街焦虑的心情，或许不难理解。核心原因在于，财务数字所隐藏的真相，似乎并不只是管理层表述的那样乐观。最关键的一点，即便假设受到影响的18%的群体收入为0，但总规模也只在3500万美元-4000万美元之间。而精密科学下调的Cologuard销售预期，在8000万美元左右，相差较大。换句话说，即便没有飓风影响，精密科学的业绩仍然是不及预期的。这背后，还有什么原因？在投资者的追问下，除了飓风之外的因素，也在浮出水面。首先，在8到10月的旺季，Cologuard的放量确实不及预期。这与精密科学传统渠道的变现能力减弱有关。管理层谈到，美国人看病的方式正在发生变化，其中一项就是看普通门诊的次数减少。这也意味着，精密科学需要开拓更多的渠道，维持增长。但遗憾的是，新客户处方爬坡速度低于预期。其次，精密科学的销售管理似乎出现了问题，包括管理层变动、人员更迭等。因此，分析师提出了疑问：公司商业化层面是否陷入动荡？不过，对于这个问题，精密科学的管理层选择了回避，并没有直面回答。这也让市场担心，精密科学销售团队的“生产力”有一定下滑。在聚焦公司是否出现问题的同时，市场也十分关注整个市场是否存在需求不足的问题。在这一逻辑下，分析师希望能够得到一个准确的数字，包括飓风等不同因素的影响规模。不过，这也未能得公司的具体答案。但是，一个确定的事实是，未来竞争加剧是肯定的。在液体活检领域，Guardant Health Shield已经获批上市，虽然性能有待提升，但仍是一个不确定性因素。后续，还包括Mainz Biomed、Prescient Metabiomics 和 Geneoscopy等潜在竞争对手，或将在美国市场推出基于粪便的结直肠癌检测产品。在这一逻辑下，华尔街选择谨慎，也可以理解。 / 03 / 现象级产品的谜团当然，现在哪一方是错的，并没有明确的答案。关于Cologuard的增长问题，仍然有待时间去验证。但不管怎么说，谜团最终的答案，都不会影响一个既定事实：Cologuard是肿瘤早筛第一个成功的商业化现象级产品，也充分论证了肿瘤早筛商业模型的可行性。并且，Cologuard持续增长的规模，也让我们看到了支付方（医保等）对于肿瘤早筛的认可程度，以及普通民众对于早筛的认可程度。在第三季报及电话会议中，精密科学透露出的两个维度的数据，是非常值得关注的。一个，是“遵从率”数据。所谓依从性，统计口径是：支付方发起大规模筛查的情况下，发出去产品与回收产品的比值。比如，发放了1万个筛查产品，最终回收了1000个，“遵从率”就是10%。“遵从率”越高，说明市场对于这类早筛产品的接受度越高。直观的感受是，FIT产品的“遵从率”只有10%左右，但Cologuard今年的“遵从率”在22%左右，第三季度甚至增长到了24%。这说明，即便是没有接触过早筛产品的消费者，对于这类产品的接受度其实并不低，并且经受市场教育之后还能持续增长，这保证了早筛产品的增长潜力。另一个，则是复购数据。“遵从率”体现了新消费者的接受程度，而复购数据则体现了成熟用户的接受程度。精密科学没有明确阐述复购率的数据，但提到复购销售收入将会从现在的25%，提升到未来的50%以上。这也说明了，存量用户对于肿瘤早筛产品的认可。新用户接受程度可观，存量用户足够认可，证明肿瘤早筛产品的放量逻辑扎实。不管Cologuard是否遇到瓶颈，未来还会有更多类似于“Cologuard”产品脱颖而出。肿瘤早筛赛道的前景，仍然是光明的。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

并购财报

2024-08-14

·Business Wire

Geneoscopy to Present at Gastroenterology and Cancer Surveillance Conferences, Highlighting Advancements in Colorectal Cancer Screening and Early Detection

ST. LOUIS--( BUSINESS WIRE )-- Geneoscopy, Inc ., a life sciences company focused on developing diagnostic tests for the advancement of gastrointestinal health, announced that Erica Barnell, MD, PhD, Geneoscopy’s Chief Medical & Science Officer, will present at two important healthcare conferences, showcasing advancements in colorectal cancer (CRC) screening and early detection. Ca mbridge He althtech Institute’s Early Cancer Surveillance Dx Roundtable Breakout Discussions Topic: “Blood-based Colorectal Cancer Screening Tests – Ready for Prime-Time as a First Line Screening Test?” Date & Time: Aug. 21, 2024, at 9:30 a.m. EDT About: The presentation will shed light on the latest data and perspectives on blood-based CRC screening tests and examine recent clinical trial results. The discussion will review the benefits of blood tests, including higher patient compliance and broader demographic reach, while also addressing the challenges posed by lower sensitivity in detecting stage 1 cancer and pre-cancers compared to standard tests like colonoscopy and at-home, stool-based screening tests. American Co llege of Gastroenterology Virtual Grand Rounds Topic: “What the Practicing GI Clinician Needs to Know About Stool-Based Testing” Date & Time: Aug. 22, 2024, at 12:00 p.m. and 8:00 p.m. EDT (a pre-recorded session will also be available on ACG Education Universe on Aug. 30, 2024) About: In this discussion, Dr. Barnell and Dr. Thomas F. Imperiale, Indiana University School of Medicine and the Regenstrief Institute, will delve into the significance of stool-based testing, covering its use and implications, and role for practicing gastroenterologists. The session will explore the comparative advantages of stool-based tests over blood tests and colonoscopies, examine how sensitivity and specificity rates affect test selection, and discuss key factors influencing the recommendation of stool-based testing to patients. “I am honored to participate in these important discussions alongside leading researchers to help advance the field of gastroenterology and early CRC detection,” Dr. Barnell said. “By exploring the latest in stool-based and blood-based testing, we are paving the way for more accurate, accessible, and patient-friendly screening methods. Our goal is to ensure that patients benefit from these innovations, leading to earlier cancer detection, better treatment outcomes, and ultimately, improved survival rates.” More than 44 million Americans at average risk for CRC remain unscreened despite screening’s vital role in early detection and prevention. Access to reliable options for screening enhances the ability to detect disease early and provides valuable information to guide personalized treatment options. Geneoscopy’s FDA-approved noninvasive CRC screening test, ColoSense™, is the first to use an RNA-based assay, offering a dynamic view of disease activity. About Geneoscopy, Inc. Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. The company’s FDA-approved ColoSense™ test uses a proprietary RNA-based platform to screen for colorectal cancer and advanced adenomas for average-risk individuals over the age of 45. In partnership with leading universities and biopharmaceutical companies, Geneoscopy is also developing diagnostic tests for treatment selection and therapy monitoring in other GI disease areas. For more information, visit www.geneoscopy.com and follow the company on LinkedIn .

100 项与 Geneoscopy, Inc. 相关的药物交易

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100 项与 Geneoscopy, Inc. 相关的转化医学

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