NEW YORK – Exact Sciences said Tuesday that it enrolled the first patient into its multi-cancer early detection (MCED) Falcon Registry Real-World Evidence study.
The US Food and Drug Administration recently granted an investigational device exemption for the Madison, Wisconsin-based company's lab-developed MCED test, allowing its use in the Falcon Registry.
The study aims to recruit up to 25,000 participants and to assess the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Patients aged 50 to 80 with no history of cancer will receive annual MCED testing for three years, with two additional years of follow-on data collection. Data from this cohort will be compared to that collected from a comparator cohort of up to 50,000 patients who are demographically and clinically similar to the study cohort but who receive standard care without MCED testing.
The first participant joined the study at Texas not-for-profit health system Baylor Scott & White Health, the Falcon study's primary site. Chicago-based Endeavor Health will begin enrolling patients this fall.
Exact Sciences hopes that the study will inform further development and commercialization of its MCED test and support discussions with regulatory agencies, payors, and guideline bodies.
"Exact Sciences is dedicated to advancing an MCED test, as it offers a highly promising way to make an impact on the burden of cancer," Tom Beer, chief medical officer and VP of MCED at Exact Sciences, said in a statement.
"Early detection through screening improves outcomes," Beer said, "yet two-thirds of cancer cases and deaths are due to cancers that do not have recommended screening options. Our collaboration with Baylor Scott & White and Endeavor Health is a crucial step forward and represents a tremendous opportunity to help transform cancer care."