Exact Sciences: 1st patient enrolled in MCED Falcon Registry RWE study

Exact Sciences 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 1.4M 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…”Implementing MCED testing and advancing preventative genomics are crucial steps in addressing the ‘last mile’ problem in health care,” said Peter Hulick, M.D., the Janardan D. Khandekar, M.D., chair of personalized medicine and the director of the Mark R. Neaman Center for Personalized Medicine at Endeavor Health. “The Falcon Registry is a pivotal research study to meet the real-world challenges of implementation and aligns with the broader vision of the Davis Family Center for Preventive Genomics at Endeavor Health, which is to assist patients, their families, and caregivers in making better-informed decisions about early diagnosis, prevention strategies, and personalized treatment options.” .