Mercy BioAnalytics Receives Breakthrough Device Designation for Ovarian Cancer Screening in Asymptomatic, Postmenopausal Women

WALTHAM, Mass., May 29, 2024 /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 Halo™ 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 Dawn Mattoon, 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 June 3^rd, at the upcoming ASCO meeting, Mercy will share data from their landmark study in a poster titled "Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women." In this study, Mercy analyzed samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) in which 200,000 women were enrolled, randomized to no screening or annual screening, and followed for up to 20 years. All trial participants donated a blood sample at the time of enrollment. Mercy analyzed the blood of more than 1,300 trial participants to assess the sensitivity and specificity of the Mercy Halo test for detecting ovarian cancer up to three years prior to clinical diagnosis. In this study, Mercy Halo outperformed CA125 in both the ability to detect high-grade serous ovarian cancer (82% vs 63% sensitivity), and in test specificity (98% vs 96%), significantly increasing the number of cancers identified while reducing the number of false positives by almost half.  

The Mercy Halo test achieves high sensitivity and specificity through the simultaneous detection of multiple cancer-related biomarkers co-localized on the surface of individual tumor-associated extracellular vesicles. The high abundance of extracellular vesicles in circulation enables the Mercy Halo test to be run on a very small volume of serum or plasma with a simple qPCR-based read-out, unlike cell-free DNA-based tests which typically require a larger volume of blood and next-generation sequencing to generate results.

About Mercy BioAnalytics
Mercy BioAnalytics, Inc. is on a mission to relieve suffering and save lives through the early detection of cancer. Early-stage cancer is difficult to detect, but when found, is more often amenable to curative therapy. The patented Mercy Halo™ liquid biopsy platform utilizes biomarker co-localization to interrogate highly abundant, blood-based extracellular vesicles that carry unique cancer signatures from their parent cells. The Mercy Halo platform is designed to detect Stage I cancer, when it is most treatable, and enhance the quality of life for cancer patients and their families. Mercy's initial focus is the early detection of ovarian and lung cancers. Ovarian cancer, the most lethal gynecological cancer, typically goes undetected until it is too late to cure. Lung cancer, the number one cancer killer, takes more lives than breast and prostate cancers combined.

SOURCE Mercy BioAnalytics