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.
精密科學公司（NASDAQ: EXAS）是一家領先的癌症篩查和診斷測試提供商，今天宣佈在拜爾斯科特和懷特進行了多癌早期檢測（MCED）Falco註冊實際證據（RWE）研究的首位患者加入。這是德克薩斯州最大的非營利性醫療系統，也是主要的研究地點。該多中心研究將招募高達25,000名患者，評估MCED測試的臨床表現、患者和提供者的經驗以及心理影響，爲期五年。艾恩德弗爾健康是芝加哥地區的一個醫療系統，爲超過140萬患者提供服務，將從今年秋季開始招募患者。美國食品和藥物管理局（FDA）最近授權了精密科學MCED測試的研究性設備豁免，允許其在Falco註冊表中使用。此項研究將爲進一步完善公司未來MCED測試的開發和商業化提供寶貴的見解，並支持與監管機構、支付者和指南機構的討論。
譯文內容由第三人軟體翻譯。