On August 20, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported 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 (Press release, Exact Sciences, AUG 20, 2024, View Source [SID1234646006]). 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.
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"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," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "Too often, cancers go undetected until symptoms appear, resulting in diagnoses at advanced, less treatable stages. Early detection through screening improves outcomes, yet two-thirds of cancer cases and deaths are due to cancers that do not have recommended screening options. 1 Our collaboration with Baylor Scott & White and Endeavor Health is a crucial step forward and represents a tremendous opportunity to help transform cancer care."
To better understand the impact of MCED testing on patient care, the study will use a registry approach, tracking patient data over time to evaluate outcomes and improve future treatments. Up to 25,000 patients ages 50-80 with no history of cancer will participate in annual MCED testing for three years and two additional years of follow-up data collection. Data will also be collected for a comparator cohort of up to 50,000 patients, demographically and clinically similar to the study cohort but receiving standard care without the MCED test. The Exact Sciences MCED test features two high-performing biomarker classes known for their ability to identify cancer early, offering sensitivity and specificity that can detect aggressive cancers and those lacking current standard of care screening. 2
"With this important work, we aim to intercept cancer earlier than ever before," said Ronan Kelly, M.D., principal investigator of the MCED Falcon Registry Real-World Evidence study. Dr. Kelly is the director of oncology, Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center — Dallas, and chief of oncology, North Texas Division, Baylor Scott & White Health. "We are eager to do our part in the national effort to decrease cancer mortality by 50% over the next 25 years, as outlined in the U.S. government’s Cancer Moonshot initiative. This important study is helping advance proactive cancer detection efforts, and we are excited to help close gaps in existing cancer screening programs."
Cancer remains the second leading cause of death in the United States, with over 2 million new cases and approximately 611,000 deaths projected for 2024. 3 Advancing early detection through innovative approaches like MCED testing has never been more critical. Baylor Scott & White and Endeavor Health, located in distinct parts of the country and serving a diverse range of communities, will help reach a broad representative group of Americans and provide insights on the potential benefits of early detection across diverse populations.
"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."
The Exact Sciences MCED test is available to patients who have consented and enrolled in the Falcon Registry study. It has not been cleared or approved by the U.S. Food and Drug Administration or other notified regulatory authority. The test was developed and its performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.