Mercy BioAnalytics Gets Breakthrough Device Nod for Ovarian Cancer Screening in Asymptomatic Postmenopausal Women

Mercy BioAnalytics, Inc., a front-runner in employing extracellular vesicle-based liquid biopsies for early cancer detection, recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This prestigious recognition was awarded for their Mercy Halo™ Ovarian Cancer Screening Test, intended for asymptomatic, postmenopausal women. The FDA’s Breakthrough Devices program is designed to accelerate patient access to groundbreaking technology that offers more effective diagnostics for severe health conditions. Notably, there is currently no FDA-approved method specifically for ovarian cancer screening.

Ovarian cancer ranks as one of the most deadly cancers among women, claiming nearly 13,000 lives annually in the U.S. The majority of ovarian cancer cases—more than 70%—are diagnosed in women over the age of 50. Alarmingly, almost 80% of these diagnoses occur at an advanced stage, where survival rates are significantly lower.

Dawn Mattoon, PhD, CEO of Mercy BioAnalytics, emphasized the company’s commitment to working closely with the FDA to facilitate the regulatory approval of their ovarian cancer screening test. "We aim to empower the 63 million postmenopausal women in the U.S. with a proactive health tool," she stated. Mattoon hailed the FDA's designation of the Mercy Halo Ovarian Cancer Test as a milestone that highlights the innovative work at Mercy and brings them closer to their mission of saving lives globally through early cancer detection.

Mercy BioAnalytics is set to present data from their pivotal study at the ASCO meeting on June 3rd. This study, titled "Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women," drew on samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). The trial enrolled 200,000 women who were randomized into groups with no screening or annual screening and monitored for up to 20 years. Each participant provided a blood sample upon enrollment, and Mercy analyzed the blood of over 1,300 participants to evaluate the performance of the Mercy Halo test.

The results indicated that the Mercy Halo test surpassed the CA125 test both in detecting high-grade serous ovarian cancer (82% vs. 63% sensitivity) and in specificity (98% vs. 96%). This improved accuracy means that the Mercy Halo test could identify more cancers while significantly reducing false-positive results.

The Mercy Halo test achieves its high sensitivity and specificity by detecting multiple cancer-related biomarkers co-located on the surface of individual tumor-associated extracellular vesicles. Thanks to the high number of extracellular vesicles present in blood, the Mercy Halo test can be conducted using a small volume of serum or plasma with a straightforward qPCR-based readout. This differs from cell-free DNA-based tests, which typically require larger blood volumes and advanced next-generation sequencing for results.

Mercy BioAnalytics is dedicated to alleviating suffering and saving lives through the early detection of cancer. Their patented Mercy Halo™ liquid biopsy platform uses biomarker co-localization to analyze abundant, blood-based extracellular vesicles that carry unique cancer signatures from their parent cells. Aimed at detecting Stage I cancer, the platform seeks to improve the quality of life for cancer patients and their families. Currently, Mercy's primary focus is on early detection of ovarian and lung cancers. Ovarian cancer, the deadliest gynecological cancer, often remains undetected until it is incurable, while lung cancer claims more lives than breast and prostate cancers combined.