Newswise — WALTHAM, Mass., April 24, 2024 /PRNewswire/ -- Mercy BioAnalytics, Inc., a pioneer in extracellular vesicle-based liquid biopsy for the early detection of cancer, will present data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting showing the performance of its Mercy Halo™ Ovarian Cancer screening test in a large cohort of asymptomatic, postmenopausal women. The results of the study, which included more than 1,300 women, will be shared in a poster presentation on June 3rd, 2024.
Ovarian cancer is one of the leading causes of cancer death among women. 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. Today, there are no guideline-recommended screening tests for ovarian cancer, which kills nearly 13,000 women each year in the US alone.
"Legacy technologies such as CA125 serum biomarker testing and transvaginal ultrasound imaging have not proven accurate enough to justify their use for population ovarian cancer screening. Unfortunately, no alternative technology has demonstrated superior clinical performance in a screening population since CA125 and transvaginal ultrasound were introduced nearly four decades ago," said Dawn Mattoon, PhD, Mercy's CEO.
Mercy is developing a highly sensitive and specific screening test designed to help detect ovarian cancer earlier in asymptomatic, postmenopausal women. 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.
"This study allowed us to see how far in advance of the presentation of clinical disease our test can detect early-stage ovarian cancer, and at what sensitivity and specificity," Mattoon said. "We're excited to share the outstanding performance of the Mercy Halo test in this large patient cohort that is representative of our intended patient population."
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.
The Mercy ovarian cancer data will be shared on June 3rd in a poster titled "Evaluation of a novel extracellular vesicle (EV) based ovarian cancer (OC) screening test in asymptomatic postmenopausal women."
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.