Exact Sciences Launches Multi-Cancer Early Detection Study With 25K Patients, Supported by FDA Authorization
Exact Sciences Launches Multi-Cancer Early Detection Study With 25K Patients, Supported by FDA Authorization
Exact Sciences Corp. (NASDAQ:EXAS), a leading provider of cancer screening and diagnostic tests, today announced that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study at Baylor Scott & White, the primary study site and largest not-for-profit health system in Texas. The multi-site study will enroll up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Endeavor Health, a Chicago-area health system serving more than 1.4 million patients, will start enrolling patients this fall. The U.S. Food and Drug Administration (FDA) recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry. This study will provide valuable insight to further inform the development and commercialization of the company's future MCED test and support discussions with regulatory agencies, payers, and guideline bodies.
精密科学公司（NASDAQ: EXAS）是一家领先的癌症筛查和诊断测试提供商，今天宣布在拜尔斯科特和怀特进行了多癌早期检测（MCED）Falco注册实际证据（RWE）研究的首位患者加入。这是德克萨斯州最大的非营利性医疗系统，也是主要的研究地点。该多中心研究将招募高达25,000名患者，评估MCED测试的临床表现、患者和提供者的经验以及心理影响，为期五年。艾恩德弗尔健康是芝加哥地区的一个医疗系统，为超过140万患者提供服务，将从今年秋季开始招募患者。美国食品和药物管理局（FDA）最近授权了精密科学MCED测试的研究性设备豁免，允许其在Falco注册表中使用。此项研究将为进一步完善公司未来MCED测试的开发和商业化提供宝贵的见解，并支持与监管机构、支付者和指南机构的讨论。