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MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the company will present modeling data evaluating the simulated benefit and burden of established CRC screening strategies, including the Cologuard Plus™ test during the American College of Gastroenterology (ACG) Annual Meeting.
威斯康星州麦迪逊市。-(商业新闻短讯)--癌症筛查和诊断测试的领先提供商Exact Sciences Corp.(纳斯达克:EXAS)今天宣布,该公司将提供建模数据,评估已建立的CRC筛查策略的模拟益处和负担,包括美国胃肠病学会(ACG)年会期间的Cologuard Plus™测试。
ACG takes place October 25-30, 2024, in Philadelphia, Pennsylvania. Exact Sciences will also present new data on improving adherence to help close the gap in CRC screening. ACG abstracts are available on the meeting website..
ACG于2024年10月25日至30日在宾夕法尼亚州费城举行。Exact Sciences还将提供有关提高依从性的新数据,以帮助缩小CRC筛查的差距。ACG摘要可在会议网站上找到。。
“Exact Sciences is pleased to share new modeling data which demonstrates the Cologuard Plus test as an efficient CRC screening strategy across modeled age ranges and screening intervals, given its high sensitivity and specificity for both cancer and precancer,” said Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences.
“精确科学很高兴分享新的建模数据,证明Cologuard Plus测试是一种有效的CRC筛查策略,可以跨越建模的年龄范围和筛查间隔,因为它对癌症和癌前病变都具有很高的敏感性和特异性,”精确科学筛查首席医学官保罗·林堡(PaulLimburg)说。
“The data demonstrate our commitment to continuous improvement and innovation to deliver best in class, patient-centric cancer screening and diagnostic solutions.”.
“这些数据表明,我们致力于不断改进和创新,以提供同类最佳、以患者为中心的癌症筛查和诊断解决方案。”。
Researchers used a validated simulation model to assess the benefit to burden ratio of the Cologuard Plus test and other established and emerging CRC screening options. Benefit was defined as life-years gained and burden as the lifetime number of colonoscopies.
研究人员使用经过验证的模拟模型来评估Cologuard Plus测试和其他已建立和新兴的CRC筛查选项的收益与负担比。益处被定义为获得的生命年和负担作为结肠镜检查的终生数量。
The efficient frontier abstract summary and presentation details are as follows:
有效的前沿摘要摘要和演示细节如下:
Next Generation mt-sDNA Has the Best Balance Between Benefit and Burden of Age- and Interval-Recommended CRC Screening Among Stool- and Blood-Based Tests (P2119)
在粪便和血液检测中,下一代mt-sDNA在年龄和间隔推荐的CRC筛查的益处和负担之间具有最佳平衡(P2119)
Summary: The next-generation mt-sDNA (ng-mt-sDNA) test was the only efficient non-invasive modality for screening over the guideline-recommended age interval of 45-75 years; Blood-based screening strategies were not efficient or near-efficient at any screening interval or age-range.
总结:下一代mt-sDNA(ng-mt-sDNA)测试是在指南推荐的45-75岁年龄间隔内进行筛查的唯一有效的非侵入性方式;。
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
会议时间:美国东部时间2024年10月28日星期一上午10:30至下午4:00
Increasing real-world adherence
提高现实世界的依从性
The seven remaining abstracts share patient-centric research on improving CRC screening adherence rates, particularly in underserved populations. With industry-leading patient navigation and personalized outreach, these strategies directly impact millions of lives. When modeled against the U.S. general screening population, widespread implementation of the reported strategies could drive as much as a 10% reduction in the CRC screening gap.*.
剩下的七篇摘要分享了以患者为中心的研究,以提高CRC筛查依从率,特别是在服务不足的人群中。。当以美国普通筛查人群为模型时,报告策略的广泛实施可以使CRC筛查差距减少多达10%。*。
The abstracts at ACG are as follows:
ACG的摘要如下:
Cross Sectional Adherence with the Multi Target Stool DNA Test for Colorectal Cancer Screening Among Four Largest Payors in the Country (P0437)
全国四大付款人中多靶点粪便DNA检测对结直肠癌筛查的横断面依从性(P0437)
Summary: This study demonstrates high adherence rates to mt-sDNA testing across a large, national sample of insured individuals between ages 45-85 years, with an overall cross-sectional adherence of 71.2% and an average return time of 27.3 days.
总结:这项研究表明,在45-85岁之间的大型全国投保人样本中,mt-sDNA检测的依从率很高,总体横截面依从性为71.2%,平均返回时间为27.3天。
Session: Sunday, October 27, 2024, 3:30 PM – 7:00 PM EDT
会议:美国东部时间2024年10月27日星期日下午3:30至7:00
Real-World Multi-Target Stool DNA Longitudinal Adherence for Colorectal Cancer Re-screening in a Large, National Spanish-Speaking Population (P3827)
现实世界中的多靶点粪便DNA纵向依从性,用于在一大批西班牙语国家人群中重新筛查结直肠癌(P3827)
Summary: The overall adherence rate in this population was 76.7%, with a mean time to test return of 20.2 days; Personalized patient navigation outreach with Spanish language support resulted in adherence rates exceeding 70% for CRC re-screening, across all analyzed age subgroups.
总结:该人群的总体依从率为76.7%,平均测试时间为20.2天;在所有分析的年龄亚组中,使用西班牙语支持的个性化患者导航外展导致CRC重新筛查的依从率超过70%。
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
会议时间:美国东部时间2024年10月28日星期一上午10:30至下午4:00
Gap Closure Adherence to Multi-Targeted Stool DNA Test for Colorectal Cancer Screening in an Insured Cohort (P0436)
缺口闭合坚持多靶点粪便DNA检测在受保人群中进行结直肠癌筛查(P0436)
Summary: The gap closure program achieved nearly 50% adherence, with an average of 25.5 days to return the kit; This supports mt-sDNA as an effective modality to enhance CRC screening participation.
总结:间隙闭合计划实现了近50%的依从性,平均25.5天才能归还试剂盒;这支持mt-sDNA作为增强CRC筛查参与的有效方式。
Session: Sunday October 27, 2024, 3:30 PM – 7:00 PM EDT
会议时间:美国东部夏令时2024年10月27日星期日下午3:30至7:00
Impact of Personalized Patient Outreach on Multi-Target Stool DNA Test Adherence in a Large Colorectal Cancer Screening Population (P2120)
个性化患者外展对大肠癌筛查人群多靶点粪便DNA检测依从性的影响(P2120)
Summary: Personalized patient outreach significantly improved mt-sDNA adherence for CRC screening compared to standard outreach, 63% vs 61.1% respectively.
总结:与标准外展相比,个性化患者外展显着改善了mt-sDNA对CRC筛查的依从性,分别为63%和61.1%。
Session: Tuesday, October 29, 2024, 10:30 AM – 4:00 PM EDT
会议:美国东部时间2024年10月29日星期二上午10:30至下午4:00
Impact of Spanish Language Outreach on Multi-Target Stool DNA Test Adherence in a Spanish-Speaking Population in a Federally Qualified Health Center (P3825)
在联邦合格的卫生中心,西班牙语外展对西班牙语人群多目标粪便DNA检测依从性的影响(P3825)
Summary: Preference-based multichannel navigation with Spanish language outreach significantly improved patient adherence to CRC screening in the FQHC Spanish-speaking population, increasing adherence from 45.10% to 51.60%.
总结:基于偏好的多通道导航与西班牙语推广显着提高了FQHC西班牙语人群对CRC筛查的依从性,依从性从45.10%提高到51.60%。
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
会议时间:美国东部时间2024年10月28日星期一上午10:30至下午4:00
Impact of Preference-Based Digital Navigation on Multi-Target Stool DNA Test Adherence in a Large Colorectal Cancer Screening Population (P2118)
基于偏好的数字导航对大肠癌筛查人群多靶点粪便DNA检测依从性的影响(P2118)
Summary: Overall mt-sDNA adherence was 63.7% and analysis by communication type revealed that mt-sDNA significantly improved adherence: SMS + email (66.5%), SMS (62.9%), email (64.2%), no digital (57.4%). Additionally, SMS + email demonstrated the shortest average return time (20.1 days).
总结:总体mt-sDNA依从性为63.7%,按通信类型分析显示mt-sDNA显着提高了依从性:SMS+电子邮件(66.5%),SMS(62.9%),电子邮件(64.2%),无数字(57.4%)。此外,短信+电子邮件的平均返回时间最短(20.1天)。
Session: Monday, October 28, 2024, 10:30 AM – 4:00 PM EDT
会议时间:美国东部时间2024年10月28日星期一上午10:30至下午4:00
Impact of Spanish Language Patient Navigation on Multi-Target Stool DNA Test Adherence Among Spanish-Speaking Patient Population (P3826)
西班牙语患者导航对西班牙语患者人群多目标粪便DNA检测依从性的影响(P3826)
Summary: Personalized Spanish-language outreach in a predominantly Spanish-speaking Hispanic patient population significantly improved mt-sDNA adherence rates; The Spanish language outreach group exhibited higher mt-sDNA adherence than English language outreach group (62.0% vs. 57.3%), while also exhibiting increased odds of mt-sDNA adherence..
总结:在以西班牙语为主的西班牙裔患者群体中,个性化的西班牙语推广显着提高了mt-sDNA依从率;西班牙语外联组比英语外联组表现出更高的mt-sDNA依从性(62.0%比57.3%),同时也表现出mt-sDNA依从性的增加。。
Session: Tuesday, October 29, 2024, 10:30 AM – 4:00 PM EDT
会议:美国东部时间2024年10月29日星期二上午10:30至下午4:00
Meet Exact Sciences Booth Event
会见精确科学展台活动
Exact Sciences will host two information sessions at the company’s booth (#839), These sessions will be led by Burak Ozbay, PhD, MBA, BPharm, Vice President of Health Economics and Outcomes Research. The sessions will focus on precancer detection and what modeling can inform about CRC screening tests.
。会议将重点讨论癌前检测以及建模可以为CRC筛查测试提供哪些信息。
The booth sessions will take place Sunday, October 27 and Monday, October 28 at 5:30 pm and 10:45 am EDT..
展台会议将于美国东部时间10月27日星期日和10月28日星期一下午5:30和上午10:45举行。。
*Estimates based on modeling abstract performance against U.S. based population cohorts of: # of Medicare Advantage members, U.S. Hispanics and unscreened U.S. citizens.
*基于对美国人口群体的抽象表现建模的估计:医疗保险优势成员,美国西班牙裔和未经筛查的美国公民。
About the BLUE-C Study
关于BLUE-C研究
BLUE-C was a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of next-generation Cologuard (multi-target stool DNA or mt-sDNA). Using colonoscopy as a reference method, the robust study design compared next-generation Cologuard and a fecal immunochemical test (FIT).
BLUE-C是一项针对20 000多名40岁及以上成年人的多中心前瞻性研究(NCT04144738)。。使用结肠镜检查作为参考方法,稳健的研究设计比较了下一代Cologuard和粪便免疫化学测试(FIT)。
Blood samples were also collected for later evaluation of a blood-based screening test being developed by Exact Sciences. BLUE-C is one of the largest colorectal cancer screening trials ever conducted, and the study population reflects the racial and ethnic makeup of the United States according to the 2020 census..
还收集了血液样本,以供以后评估由Exact Sciences开发的基于血液的筛查测试。。。
About the Cologuard Plus™ test
关于Cologuard Plus™测试
Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences' lab and increase the valid result rate. Exact Sciences expects to launch the test with Medicare coverage and guideline inclusion in 2025..
与梅奥诊所合作开发的Cologuard Plus测试具有新颖的生物标志物和改进的实验室过程。它还包含增强的样品稳定性组件,为患者提供更多时间将样品返回精确科学实验室,并提高有效结果率。精确科学预计将在2025年推出这项测试,包括医疗保险覆盖率和指南。。
About the Cologuard® Test
关于Cologuard®测试
The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).
Cologuard测试是一种一线结直肠癌筛查测试,适用于45岁或以上的平均患病风险的成年人。它被美国癌症协会(2018)和美国预防服务工作组(2021)纳入国家结直肠癌筛查指南。
The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal phase 3 DeeP-C study.
Cologuard测试通过为平均风险人群提供一流的无创检测选择,彻底改变了结直肠癌筛查。该测试寻找粪便中与结直肠癌和癌前病变相关的某些DNA标记物和血液,并在关键的3期DeeP-C研究中显示可有效检测结直肠癌和癌前病变。
The Cologuard test is easy to use. It can be completed at home and does not require any time off or special preparation. In the initial 10 years since launch, the Cologuard test was used more than 16 million times..
Cologuard测试易于使用。它可以在家里完成,不需要任何休息或特殊准备。自推出以来的最初10年中,Cologuard测试的使用次数超过1600万次。。
Important Information About the Cologuard Test
有关Cologuard测试的重要信息
Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older.
如果您患有癌前病变、炎症性肠病和某些遗传综合征,或者有结直肠癌的个人或家族史,请不要使用Cologuard测试。Cologuard测试不能替代高危患者的结肠镜检查。根据对50岁及以上患者的大型临床研究,估计了45-49岁成年人的Cologuard测试表现。
The Cologuard test performance in repeat testing has not been evaluated..
尚未评估Cologuard在重复测试中的测试性能。。
The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.
应谨慎解释Cologuard测试结果。阳性检测结果不能证实癌症的存在。检测结果阳性的患者应转诊进行结肠镜检查。阴性检测结果不能证实没有癌症。检测结果为阴性的患者应在需要再次检测时与医生讨论。
Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit Cologuard.com. Rx only..
Medicare和大多数主要保险公司都负责Cologuard测试。有关Cologuard测试的更多信息,请访问Cologuard.com.Rx。。
About Exact Sciences Corp.
关于Exact Sciences Corp。
A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis.
作为癌症筛查和诊断测试的领先提供商,精确科学为患者和医疗保健专业人员提供了早期采取改变生活行动所需的清晰度。在Cologuard®和Oncotype®测试成功的基础上,Exact Sciences正在投资其管道,以开发用于癌症诊断之前,期间和之后的创新解决方案。
For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook..
有关更多信息,请访问ExactSciences.com,关注X(以前称为Twitter)上的Exact Sciences@ExactSciences,或在LinkedIn和Facebook上查找Exact Sciences。。
NOTE: Exact Sciences, Cologuard and Cologuard Plus are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
注:Exact Sciences、Cologuard和Cologuard Plus是Exact Sciences Corporation的商标或注册商标。Oncotype、Oncotype DX、Oncotype DX乳房复发评分、RSClin和复发评分是Genomic Health,Inc.的商标或注册商标。所有其他商标和服务标记均为其各自所有者的财产。
Cologuard is not available outside of the U.S..
Cologuard在美国境外不可用。。
Forward-Looking Statements
前瞻性声明
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated..
本新闻稿包含有关我们对未来的期望、预期、意图、信念或策略的前瞻性声明。这些前瞻性陈述基于我们截至本协议日期所做的假设,并受到已知和未知风险和不确定性的影响,这些风险和不确定性可能导致实际结果、条件和事件与预期产生重大差异。。
Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding our expectations for the commercialization of the Cologuard Plus test and the performance of the Cologuard Plus test in a commercial setting.
因此,您不应过度依赖前瞻性陈述。前瞻性陈述的例子包括关于我们对Cologuard Plus测试商业化的期望以及Cologuard Plus测试在商业环境中的性能的陈述。
Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise..
可能影响我们前瞻性陈述的风险和不确定性在我们最近的10-K表年度报告和10-Q表后续季度报告的风险因素部分以及我们提交给证券交易委员会的其他报告中进行了描述。。。