ECLIPSE study data demonstrating efficacy of Shield Blood-based Test for colorectal cancer screening to be published in The New England Journal of Medicine.-Guardant Health Inc.
Publication of ECLIPSE follows Guardant Health’s submission of its premarket approval (PMA) application to the FDA for Shield, which included key data points from the study. Since the launch of the lab-developed version of the Shield test in May 2022, it has been used by more than 20,000 people and more than 90% of patients who were prescribed the test in the real-world clinical setting completed it.
One recent study showed that CRC screening rates tripled among adults who had declined prior CRC screening when they were offered Shield. The test’s sensitivity in detecting CRC, combined with this real-world adherence, suggests that Shield has the potential to detect more CRCs at a curable stage than traditional screening method.
Tho' treatments are most effective if the disease is caught early, currently colorectal tumors rank as the second-highest cause of cancer deaths in the U.S. and more than 75% of people who die from colorectal cancer were not up-to-date with their screening, the company said. Additional barriers to care and underscreening for cancer contribute to high cancer death rates among underserved populations.
Over 50 million eligible Americans do not get recommended screenings for colorectal cancer, partly because current screening methods are inconvenient or unpleasant,” said AmirAli Talasaz, Guardant Health co-CEO. “We believe the publication of the ECLIPSE study in The New England Journal of Medicine, one of the world’s leading medical journals, is an endorsement of the quality of our clinical data and the potential value of the Shield test. We are confident that offering an accurate blood test has the potential to significantly reduce preventable colorectal cancer deaths.”
See- "A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening"-. Authors: Daniel C. Chung, M.D., Darrell M. Gray II, M.D., M.P.H., Harminder Singh, M.D., Rachel B. Issaka, M.D., M.A.S. https://orcid.org/0000-0002-9691-1655, Victoria M. Raymond, M.S. https://orcid.org/0000-0001-5223-0981, Craig Eagle, M.D., Sylvia Hu, Ph.D., +5, and William M. Grady, M.D. Author. Published March 13, 2024 . N Engl J Med 2024;390:973-983. DOI: 10.1056/NEJMoa2304714 VOL. 390 NO. 11.
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