TEST:

Mercy Halo™ Test

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

"Mercy BioAnalytics, Inc...has been recognized with a Distinguished Abstract Award for their abstract entitled 'Analytical and clinical performance of a novel ovarian cancer screening test in asymptomatic women.' The abstract was also selected for a podium presentation as part of the Distinguished Abstracts session on Tuesday, July 30th."

"Mercy BioAnalytics, Inc...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....On June 3rd, at the upcoming ASCO meeting, Mercy will share data from their landmark study in a poster....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."

"Mercy BioAnalytics, Inc...will present data at the American Society of Clinical Oncology Annual Meeting next month demonstrating the first significant improvement in the early detection of ovarian cancer using a locked assay since CA125 serum biomarker testing and transvaginal ultrasound imaging were introduced nearly 40 years ago. In a large blinded, retrospective analysis of prospectively collected samples from more than 1,300 asymptomatic postmenopausal women, the Mercy Halo™ test detected 82% of high grade serous ovarian cancer (HGSC) cases up to one year prior to diagnosis with 98% specificity."

"Mercy BioAnalytics, Inc...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."

"Mercy BioAnalytics, Inc...announced it has closed a $41 million Series A financing round....Proceeds from the financing will be used to advance development and commercialization of the Mercy Halo test for high-risk lung cancer screening, the company’s lead clinical indication....Funds will also be used to advance clinical programs in additional indications, including ovarian cancer, for which 80 percent of cases are diagnosed at Stage III or Stage IV with poor long-term survival. Mercy intends to leverage its Mercy Halo liquid biopsy platform technology to develop a broad portfolio of tests for the early detection of cancer....Mercy will be presenting additional new data at the upcoming AACR conference in Orlando, Florida this month, and at the upcoming International Society for Extracellular Vesicles (ISEV) annual meeting in Seattle, Washington in May."

Tumor-derived EVs are a robust analyte for liquid-biopsy assays which can readily be detected using our platform technology. This PoC study suggests Mercy Halo can discriminate all stages of HGSOC from benign and healthy samples in human plasma with high sensitivity and specificity and is being investigated for extensibility in other cancers and diseases.

"Mercy BioAnalytics™...announced that the Mercy Halo™ Ovarian Cancer (OC) assay substantially outperformed CA125 when distinguishing patients with early-stage high-grade serious ovarian cancer (HGSOC) from women with benign conditions in a new study to be presented next week at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting. The assay uses a novel method of analyzing biomarkers based on individual extracellular vesicles (EVs)...Mercy’s assay shows promise in improving on CA125 by distinguishing stage I/II cancer from benign ovarian tumors and could have clinical utility for both early detection and surgical referral recommendation for benign and malignant ovarian tumors,'...."