Mercy BioAnalytics Announces Dual Publications in Journal of Molecular Diagnostics

Publications describe foundational technology and the verification of the Mercy Halo™ ovarian cancer screening test

WALTHAM, Mass., Sept. 30, 2024 /PRNewswire/ -- The Journal of Molecular Diagnostics has published two companion papers describing a novel technology platform and clinical verification of an ovarian cancer test based on the platform from Mercy BioAnalytics, Inc., a pioneer in blood-based detection of early-stage cancer.

Only a handful of cancer screening tests have been broadly adopted because of the high performance bar that must be achieved. Tests must be sensitive enough to detect nearly all cancers but specific enough to protect against unnecessary anxiety and intervention. Additionally, test costs must be low enough to enable routine screening of the entire at-risk population. Mercy BioAnalytics has embraced these challenges, and these publications provide compelling preliminary evidence of significant progress toward the development of a safe and effective ovarian cancer screening test for postmenopausal women, the group most affected by the disease.

The Mercy Halo Technology Platform

The first publication, "Colocalization of cancer-associated biomarkers on single extracellular vesicles for early detection of cancer" details Mercy's groundbreaking technology platform.

Mercy's key insight is that tumor-derived extracellular vesicles (EVs) are among the most abundant biomarkers in the blood, offering significant advantages for detecting early-stage cancers compared to lower-abundance markers like circulating tumor DNA. By measuring co-localized membrane proteins on the surface of these tumor-associated EVs, the platform enables a highly sensitive and specific determination of cancer presence or absence. The combination of a simple assay design and a qPCR readout also enables low-cost testing. This innovative combination of features allows the Mercy Halo platform to achieve the high performance and broad accessibility required for a population-wide cancer screening test. Mercy has used this foundational technology platform to generate promising clinical data for the early detection of ovarian cancer, reported in a second companion paper.  

Clinical Verification of The Mercy Halo Platform for Ovarian Cancer Screening

Ovarian cancer is one of the leading causes of cancer-related death among women, with nearly 13,000 deaths expected in the U.S. this year. More than 80% of ovarian cancer cases are diagnosed in women 50 and older, and nearly 75% are detected at an advanced stage, where survival rates are poor. The majority of deaths are linked to high-grade serous carcinoma (HGSC), making early detection of this subtype especially critical. Given the low incidence and high mortality of ovarian cancer, any screening test must be both highly sensitive and highly specific to be effective.

Despite decades of research, no test has demonstrated the necessary sensitivity and specificity to merit broad use in ovarian cancer screening. CA125 serum biomarker testing and transvaginal ultrasound imaging frequently miss early-stage ovarian cancers and often produce false positives, incorrectly classifying healthy women as potentially having cancer, leading to unnecessary and invasive diagnostic procedures.

The second publication, titled "Improving specificity for ovarian cancer screening using a novel extracellular vesicle-based blood test – Performance in a training and verification cohort" demonstrates that the Mercy Halo technology can detect HGSC with both high sensitivity and specificity. Mercy's test offers the potential for significant improvement over existing approaches and may be suitable for ovarian cancer screening.

A HGSC case-control training clinical sample set from 397 women obtained from the Ontario Tumor Bank (OTB) and the Ovarian Cancer Research Program (OVCARE) was used to lock down the test design, the data interpretation algorithm, and establish the cut-off between cancer and non-cancer in the Mercy Halo assay. Test performance was then verified in an independent blinded case-control study with 390 serum samples obtained at diagnosis from the MRC Clinical Trials Unit (CTU) at UCL UK Ovarian Cancer Population Study (UKOPS) biobank. In the verification study, the test showed 97.0% specificity, 97.0% HGSC sensitivity, and an AUC of 0.97. This included a sensitivity of 84.6% for stage I and 100% for stage II, with a specificity of 97%. Compared to CA125, this test produced fewer false positives in patients with benign ovarian tumors, non-ovarian cancers, and inflammatory conditions, suggesting it may be a promising tool for ovarian cancer screening.

"These two seminal publications mark a significant step forward in our efforts to reduce suffering and save lives through the early detection of cancer." said Dawn Mattoon, Ph.D., Mercy's Chief Executive Officer. "They validate the incredible potential of our Mercy Halo technology platform and demonstrate our dedication to improving patient outcomes, starting with ovarian cancer."

"The superior performance of the Mercy Halo test in comparison to serum CA125 is promising. We look forward to further evaluation of the test using samples prior to clinical diagnosis from the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)," said Professor Usha Menon at MRC CTU at UCL, Chief Investigator of UKCTOCS.

These articles are available online at the Journal of Molecular Diagnostics (paper 1 here and paper 2 here) and will be featured in an upcoming print issue.

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 early-stage 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.

About Medical Research Council Clinical Trials Unit at University College London
The MRC CTU at UCL is at the forefront of resolving internationally important questions in infectious diseases and cancer and delivering swifter and more effective translation of scientific research into patient benefits. It does this by carrying out challenging and innovative studies, and developing and implementing methodological advances in study design, conduct and analysis.

SOURCE Mercy BioAnalytics