AUSTIN, Texas, June 03, 2021 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (Nasdaq: AWH), a bioanalytical-based women’s health company focused on gynecologic disease, released the analytical and initial clinical data for OVASight™ in an abstract titled “Serum-based Assay for Adnexal Mass Risk of Ovarian Malignancy”. Registrants attending the American Society of Clinical Oncology (“ASCO”) 2021 virtual meeting gained access to the poster on May 19, 2021, and the on-demand presentation will be released to the ASCO virtual meeting registrants at 9:00 a.m. EDT on June 4, 2021.
OVASight (MIA3G) is third-generation OVA technology and is a laboratory-developed, blood-based pelvic mass risk assessment test for ovarian cancer in a low prevalence population. It was developed to increase specificity, maintain high sensitivity with early-stage disease, and allow for conservative management of women with a suspected benign mass. A total of 596 samples collected from real-world patients were used to validate the OVASight diagnostic algorithm. Validation data demonstrated 89% Specificity, 91% Sensitivity and a Negative Predictive Value of 99.6% in a low prevalence population (3.8%). In addition, overall sensitivity as well as sensitivity in early-stage disease were significantly better than CA-125 alone. See table below:
| MIA3G (OVASight) | CA125 | |
| Overall Sensitivity (All Stages) | 21/23 (91.3%) | 15/23 (65.2%) |
| Early-Stage (Stage I & II) Sensitivity | 10/12 (83.0%) | 6/12 (50.0%) |
“Based on this promising data, we are thrilled with the performance of this new test,” stated Elena Ratner, M.D., Global Chief Global Medical Advisor, Clinical and Translational Medicine at Aspira Women’s Health. Dr. Ratner further explained that “it is important to give providers better tools to help provide personalized risk assessment for women with pelvic masses and expectant management for those masses that are most likely benign.”
Below are details of the abstract accepted at ASCO. All posters will be available to ASCO 2021 virtual meeting registrants on-demand beginning at 9:00 a.m. EDT on June 4, 2021.
| 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 |
About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. (formerly known as Vermillion, Inc., Nasdaq: VRML) is transforming women’s health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women. Aspira Women’s Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1® plus combines our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. ASPIRA GenetiXSM testing offers both targeted and comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health has expertise in cutting-edge research to inform our next generation of products. Our focus is on delivering products that allow healthcare providers to stratify risk, facilitate early detection and optimize treatment plans. The next generation of products in development are OVASight™ and EndoCheck™. Visit our website for more information at www.aspirawh.com.
Investor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-430-7577
Arr@lifesciadvisors.com