, /PRNewswire/ -- Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsy for the early detection of cancer, has been granted Breakthrough Device Designation from the U.S.
Food and Drug Administration (FDA) for the use of its Mercy HaloTM Ovarian Cancer Screening Test in asymptomatic, postmenopausal women. The Breakthrough Devices program is intended to help give patients more timely access to innovative tests like Mercy Halo that provide more effective diagnosis for life-threatening diseases. There is currently no FDA approved method for ovarian cancer screening.
Ovarian cancer is one of the leading causes of cancer death among women and will kill nearly 13,000 women in the U.S. this year.
More than 70% of ovarian cancer is diagnosed in women over 50 years of age, and nearly 80% of ovarian cancer is diagnosed at an advanced stage of disease, when survival is poor. "Mercy is committed to working closely with the FDA to bring our ovarian cancer screening test efficiently through the regulatory process, in order to empower the sixty-three million postmenopausal women in the U.S.
with a tool to more proactively manage their health," said , PhD, Mercy's CEO. "The Breakthrough Device Designation for our Mercy Halo Ovarian Cancer Test is recognition of the cutting-edge work being done at Mercy and a major milestone on the path to achieving our mission of saving lives globally through early cancer detection." On , at the upcoming ASCO meeting, Mercy will sha.
