Exact Sciences (EXAS) Enrolls First Patient in Pivotal MCED Study

Company Overview - Exact Sciences Corporation (EXAS) has initiated its pivotal Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study, enrolling its first patient at Baylor Scott & White in Texas, with Endeavor Health in Chicago set to begin patient enrollment this fall [1] - The study aims to register up to 25,000 patients over five years to evaluate the clinical performance, patient and provider experience, and psychological impact of MCED testing [1][4] Study Relevance - Cancer is the second leading cause of death in the U.S., with over 2 million new cases and approximately 611,000 deaths projected for 2024 [2] - Early detection through screening is crucial, as nearly two-thirds of cancer cases and deaths occur from cancers without recommended screening options [2] MCED Test Features - The Exact Sciences MCED test utilizes two high-performing biomarker classes to identify cancer early, demonstrating sensitivity and specificity for aggressive cancers and those lacking standard screening [3] - The test is currently available to patients enrolled in the Falcon Registry study and has not yet received FDA approval [3] Falcon Registry Study Details - The study will track patient data over time, involving up to 25,000 patients aged 50-80 with no cancer history, undergoing annual MCED testing for three years, followed by two years of follow-up [4] - A comparator cohort of up to 50,000 patients receiving standard care will also be included to evaluate the benefits of early detection [4] Industry Prospects - The global MCED market is valued at approximately $993 million in 2023, with a projected CAGR of 16.6% by 2030, driven by the rising prevalence of multiple cancers and demand for early detection methods [6] Notable Developments - In Q2 2024, Exact Sciences made significant advancements in its pipeline, particularly in colon cancer screening and multi-cancer screening [7] - The Cologuard Plus test is expected to become a leading non-invasive colon cancer screening method, having met pivotal study endpoints [7] Price Performance - Over the past year, shares of EXAS have decreased by 29.4%, contrasting with a 1% decline in the industry [8]