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Analytical and Initial Clinical Validation performance for Aspira’s OVASightTM blood-based biomarker test for Ovarian Malignancy risk assessment in women with Adnexal Masses.
Data demonstrates the ability to identify Ovarian Cancer Risk in a low prevalence population.
AUSTIN, Texas; May 13, 2021 – Aspira Women’s Health, Inc. (Nasdaq: AWH), a bioanalytical-based women’s health company focused on gynecologic disease, today announced that its abstract for “Serum-based Assay for Adnexal Mass Risk of Ovarian Malignancy” will be presented at American Society of Clinical Oncology (ASCO) 2021 meeting which will be held virtually June 4-8th, 2021.
The accepted abstract presents data demonstrating the analytical validation performance with initial clinical validity data of Aspira’s OVASightTM blood-based biomarker test for ovarian malignancy risk assessment in all women with an adnexal mass. Samples collected from real-world evidence studies with a low prevalence population of malignancy detection (<5% ) were used to validate the algorithm. This third-generation technology, which is a laboratory-developed test, will provide clinicians with a high negative predictive value to provide confidence when managing or monitoring a suspected benign mass, as well as a greater positive predictive value to increase confidence in malignancy risk. The product is expected to be available in Q4 2021.
“We are excited to have our abstract accepted and presented at ASCO. This provides the first reveal of the performance of our new OVASight technology,” stated Valerie Palmieri, President, and CEO of Aspira Women’s Health. “We believe that building off the success of OVA1®, OVERA®, and OVA1plusTM, OVASight will be a differentiator in the suspected benign mass population where the prevalence of disease is low in detecting early-stage cancer. Our goal is to categorize disease risk with confidence and to replace CA-125 test as an option for assessing risk in women with suspected benign pelvic masses.”
Below are details of the abstract accepted at ASCO. All posters will be available to meeting registrants on-demand beginning June 4, 2021, at 9:00 a.m. EDT.
Title: Serum-based assay for adnexal mass risk of ovarian malignancy
Abstract #: 5551
Authors: Daniel Ure MS, Rowan Bullock BS, Gary Altwerger MD, Elena Ratner MD, Lesley Northrop Ph.D. FACMG