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.
領先的癌症篩查和診斷測試提供商Exact Sciences Corp.（納斯達克股票代碼：EXAS）今天宣佈，第一位患者已加入其在德克薩斯州主要研究地點和最大的非營利性衛生系統貝勒斯科特和懷特進行的多癌症早期檢測（MCED）獵鷹真實世界證據（RWE）研究。這項多地點研究將招收多達25,000名患者，評估五年內MCED測試的臨床表現、患者和提供者的體驗以及心理影響。Endeavor Health是芝加哥地區的醫療系統，爲超過140萬名患者提供服務，將於今年秋天開始招收患者。美國食品藥品監督管理局（FDA）最近批准了Exact Sciences MCED測試的研究設備豁免（IDE），允許其在獵鷹註冊中使用。這項研究將提供寶貴的見解，進一步爲公司未來的MCED測試的開發和商業化提供信息，並支持與監管機構、付款人和指導機構的討論。
