Mercy BioAnalytics and UCL Study Shows Major Advances in Ovarian Cancer Screening

Mercy BioAnalytics recently unveiled promising data on their Mercy Halo™ test for early ovarian cancer detection. This novel extracellular vesicle-based liquid biopsy demonstrated 82% sensitivity and 98% specificity in a retrospective analysis of 1,300 asymptomatic women. The findings will be presented at the American Society of Clinical Oncology Annual Meeting, marking a significant advancement since the adoption of CA125 serum biomarker testing and transvaginal ultrasound imaging nearly four decades ago.

The study involved collaboration with the Medical Research Council Clinical Trials Unit (MRC CTU) at University College London (UCL), analyzing blood samples from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS), which included over 200,000 women. These participants were either subjected to no screening or annual screening and followed for up to 20 years. Mercy's analysis aimed to evaluate the efficacy of the Mercy Halo test in detecting ovarian cancer up to three years before a clinical diagnosis.

Traditional methods like CA125 and transvaginal ultrasound have struggled with low sensitivity and specificity, often leading to missed early-stage ovarian cancer cases and false positives. In contrast, the Mercy Halo™ test significantly outperformed CA125, showcasing better detection rates (82% vs. 63%) and specificity (98% vs. 96%). This advancement potentially reduces unnecessary diagnostic procedures and increases the number of accurately identified cancer cases.

Stanley Lapidus, the Board Chair of Mercy BioAnalytics, emphasized the significance of these results, suggesting that the Mercy Halo test could fill a critical gap in early cancer detection and save lives. Ovarian cancer remains a leading cause of cancer-related deaths among women, particularly affecting those over 50. The majority of cases are diagnosed at an advanced stage, where survival rates are bleak. Current diagnostic methods have not been widely adopted due to inadequate performance.

The Mercy Halo test leverages the detection of multiple cancer-related biomarkers found on the surface of tumor-associated extracellular vesicles. These vesicles are abundant in blood circulation, allowing the test to be performed with a small blood sample using a simple qPCR-based read-out, unlike more complex cell-free DNA-based tests.

Dawn Mattoon, Ph.D., CEO of Mercy BioAnalytics, highlighted the potential of early detection to change the prognosis for ovarian cancer. Early-stage detection opens the door to more effective treatments and improved survival rates. The ongoing development of high-quality, cost-effective tests aligns with Mercy's mission to enhance cancer screening and save lives.

Professor Usha Menon from MRC CTU at UCL, who leads the UKCTOCS, acknowledged the superior performance of the Mercy Halo test compared to the CA125 benchmark. The study's rigorous evaluation underscores the test's promise, and continued collaboration aims to validate these findings further, particularly using samples from the multimodal screening arm of UKCTOCS.

These results will be showcased on June 3rd in a poster presentation titled "Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women" at the ASCO meeting. The abstract detailing the study is currently available on the ASCO website.

Mercy BioAnalytics remains committed to revolutionizing cancer detection through innovative approaches. Their patented Mercy Halo™ platform focuses on identifying early-stage cancers when treatment is most effective. The company's initial efforts target ovarian and lung cancers, aiming to significantly impact patient outcomes by providing earlier and more accurate diagnoses. Meanwhile, the MRC CTU at UCL continues to lead in addressing critical health questions through groundbreaking research and innovative study designs.