FDA grants breakthrough designation for ovarian cancer liquid biopsy

A Massachusetts-based company, Mercy BioAnalytics, was granted Breakthrough Device Designation by the United States FDA for its Mercy Halo Ovarian Cancer Screening Test. This minimally invasive test is a liquid biopsy that can detect ovarian cancer in asymptomatic premenopausal women.

According to the American Cancer Society (ACS), in the US, an estimated 19,680 women will be diagnosed with ovarian cancer in 2024, making the average risk of getting ovarian cancer 1 in 87. Beyond that, roughly 12,740 women in 2024, or 1 in 130 women, will die of ovarian cancer in the US.

While multiple factors, including age, obesity, family history, no pregnancy history or late pregnancy, and endometriosis, may increase ovarian cancer risk, there is no test to detect the presence of ovarian cancer thus far.

The Cleveland Clinic notes that this lack of testing makes it difficult to diagnose the disease at an early stage. Providers often start with a pelvic exam to check for abnormal growth or enlarged organs and then escalate patients to imaging tests, blood tests — such as the CA125 test, or surgical approaches.

If the Mercy Halo Ovarian Cancer Screening Test is approved, this tool would be the first FDA-approved ovarian cancer screening method, which could offer more accessible and faster ovarian cancer diagnosis. This, in turn, could improve healthcare outcomes.

"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 US with a tool to more proactively manage their health," said Dawn Mattoon, PhD, Mercy's CEO, in the company press release. "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."

Mercy BioAnlaytics will present information on the test, including a randomized study using samples from the United Kingdom Collaborative Trial of Ovarian Cancer Screening, at the upcoming American Society of Clinical Oncology annual meeting, which highlights the test’s ability to outperform the CA125 test.