MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced performance data for its blood-based colorectal cancer (CRC) screening test. Results show sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.

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）今天宣布了其基于血液的结直肠癌（CRC）筛查测试的性能数据。结果显示，结直肠癌的敏感性为88.3%，晚期癌前病变的敏感性为31.2%，结肠镜检查证实的阴性样本的特异性为90.1%。

Results were presented today at the European Society for Medical Oncology (ESMO) Congress in an oral presentation titled, “Organ-specific performance of a multi-analyte, multi-cancer early detection (MCED) blood test in a prospectively-collected cohort.”.

结果于今天在欧洲肿瘤内科学会（ESMO）大会上发表了题为“前瞻性收集队列中多分析物，多癌症早期检测（MCED）血液检测的器官特异性表现”的口头报告。

“The Exact Sciences team is constantly innovating to help close the screening gap,” said Kevin Conroy, chairman and CEO, Exact Sciences. “The insights that led to this innovation reflect our understanding of the biology of cancer and the power of our scientific capabilities. We took a unique scientific approach to developing this test by combining a novel panel of markers.

“精确科学团队不断创新，以帮助缩小筛选差距，”精确科学董事长兼首席执行官凯文·康罗伊（KevinConroy）表示。“导致这项创新的见解反映了我们对癌症生物学的理解以及我们科学能力的力量。我们采用了独特的科学方法，通过结合一组新颖的标记物来开发这项测试。

This led to data that improve upon what we previously thought was possible with a blood-based colorectal cancer screening test.”.

这导致了数据的改进，我们以前认为基于血液的结直肠癌筛查测试是可能的。”。

To optimize the final test algorithm, Exact Sciences designed a study to simulate the screening population in the United States and better predict real-world, prospective performance of a novel test. The study consisted of more than 3,000 blood samples, including approximately 2,900 blinded, prospectively collected samples from the pivotal BLUE-C study.

为了优化最终测试算法，Exact Sciences设计了一项研究，以模拟美国的筛查人群，并更好地预测新测试的现实世界和预期性能。该研究包括3000多份血液样本，其中包括来自关键的BLUE-C研究的大约2900份盲法前瞻性收集的样本。

This analysis was prespecified with the U.S. Food and Drug Administration (FDA) and the samples will be excluded from the final clinical validation. The study also included more than 90 advanced precancerous lesions, the majority of which were prospectively collected, and 60 case-collected colorectal cancer samples.

该分析已由美国食品和药物管理局（FDA）预先指定，样品将被排除在最终临床验证之外。该研究还包括90多个晚期癌前病变，其中大多数是前瞻性收集的，以及60例收集的结直肠癌样本。

In the pivotal BLUE-C study results, performance degradation is expected for advanced precancerous lesion sensitivity and overall CRC sensitivity..

在关键的BLUE-C研究结果中，预计晚期癌前病变敏感性和整体CRC敏感性的性能会下降。。

Results of this study show the potential of a novel, highly discriminate blood-based panel of methylated DNA markers and an impactful, new marker class to detect advanced precancerous lesions and cancers at an attractive cost profile. The company will implement the innovative marker class on a new testing platform and complete additional analytical studies to support an FDA submission..

。该公司将在新的测试平台上实施创新标记类，并完成额外的分析研究，以支持FDA的提交。。

“A blood-based colorectal cancer screening test that can detect advanced precancerous lesions at a level comparable to the FIT test would be a breakthrough in this field,” said Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences. “Results from this large, well-designed study show progress toward that goal and move us one step closer toward providing average-risk patients with another non-invasive screening option.”.

“一种基于血液的结直肠癌筛查测试可以检测出与FIT测试相当的晚期癌前病变，这将是该领域的一项突破，”精准科学筛查首席医学官保罗·林堡（PaulLimburg）表示。“这项大型、精心设计的研究结果表明，朝着这一目标取得了进展，并使我们朝着为普通风险患者提供另一种非侵入性筛查选择迈进了一步。”。

BLUE-C results for Exact Sciences’ blood-based CRC screening test are now expected in the first half of 2025. Exact Sciences plans to use these results to support an FDA submission and approval and to make the blood-based CRC screening test available broadly. If approved, the blood-based CRC screening test could provide another testing option for 60 million unscreened people1 in the United States.

精准科学基于血液的CRC筛查测试的BLUE-C结果预计将于2025年上半年公布。Exact Sciences计划利用这些结果支持FDA的提交和批准，并使基于血液的CRC筛查测试广泛可用。如果获得批准，基于血液的CRC筛查测试可以为美国6000万未经筛查的人提供另一种检测选择1。

It would be supported by Exact Sciences’ commercial infrastructure and ExactNexus™ technology platform, making electronic ordering and resulting seamless for more than 350 health systems..

它将得到Exact Sciences商业基础设施和ExactNexus™技术平台的支持，为350多个医疗系统提供电子订购和无缝服务。。

The company also presented data from its multi-cancer early detection (MCED) blood test, assessing organ-specific performance of methylation and protein biomarkers in a prospectively collected cohort of samples from its ASCEND 2 study. The analysis indicated an overall sensitivity of 54.8% with 98.5% specificity in cancers without standard-of-care screening options (excluding lung) and 63.7% in the six most aggressive cancers with the shortest survival rates (esophagus, liver, lung, ovarian, pancreatic, and stomach).

该公司还提供了多癌症早期检测（MCED）血液测试的数据，评估了ASCEND 2研究中前瞻性收集的样本队列中甲基化和蛋白质生物标志物的器官特异性表现。分析表明，在没有标准护理筛查选择的癌症（不包括肺癌）中，总体敏感性为54.8%，特异性为98.5%，在生存率最短的六种最具侵袭性的癌症（食道，肝癌，肺癌，卵巢癌，胰腺癌和胃癌）。

These findings highlight the potential clinical value of using multiple biomarkers to detect various cancer types, including the most aggressive and those without recommended screening options..

这些发现突出了使用多种生物标志物检测各种癌症类型的潜在临床价值，包括最具侵袭性和没有推荐筛查选择的癌症。。

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..

。。

About the BLUE-C Study

关于BLUE-C研究

BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older.1 The trial was designed to evaluate the performance of the Cologuard PlusTM test (next generation multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based CRC screening test. BLUE-C is one of the largest, noninvasive CRC screening trials ever conducted, and the study population reflects the racial and ethnic makeup of the United States according to the 2020 census..

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）。该试验旨在评估Cologuard PlusTM测试（下一代多靶点粪便DNA或mt-sDNA）和Exact Sciences基于血液的CRC筛查测试的表现。BLUE-C是有史以来规模最大的非侵入性CRC筛查试验之一，根据2020年人口普查，研究人群反映了美国的种族和民族组成。。

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。这些前瞻性陈述是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。

There can be no assurance that we will successfully develop, launch, or market a blood-based CRC screening test, an MCED test, or any other new or improved product or service. Therefore, you should not place undue reliance on forward-looking statements. 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.

无法保证我们将成功开发、推出或销售基于血液的CRC筛查测试、MCED测试或任何其他新的或改进的产品或服务。。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。

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..

我们没有义务公开更新任何前瞻性声明，无论是书面的还是口头的，无论是由于新信息、未来发展还是其他原因。。

References

参考文献

1. Ebner DW, Kisiel JB, Fendrick AM, et al. Estimated Average-Risk Colorectal Cancer Screening-Eligible Population in the US. JAMA Netw Open. 2024;7(3):e245537.

1.Ebner DW，Kisiel JB，Fendrick AM等人。美国估计平均风险结直肠癌筛查合格人群。JAMA网络公开赛。2024年；7（3）：e245537。