Aspira Women’s Health Releases Analytical and Initial Clinical Validation Performance for OVASight at ASCO 2021

Rhea-AI Summary

Aspira Women’s Health Inc. (NASDAQ: AWH) announced promising initial clinical data for its blood-based test OVASight, aimed at assessing the risk of ovarian cancer in women with suspected benign pelvic masses. In a low prevalence population (3.8%), OVASight achieved 89% specificity, 91% sensitivity, and a negative predictive value of 99.6%. These results outperform traditional CA-125 testing in early-stage disease. The data was released during the American Society of Clinical Oncology (ASCO) 2021 virtual meeting, emphasizing the company's commitment to improving women's health.

Positive

• OVASight achieved 89% specificity and 91% sensitivity in a low prevalence population.
• Negative predictive value of 99.6% demonstrates high accuracy.
• Outperforms CA-125 testing in overall and early-stage sensitivity.

Negative

• None.

Data demonstrates the performance of OVASight in a low prevalence population- 89% Specificity, 91% Sensitivity and a Negative Predictive Value of 99.6% for the management of suspected Benign Pelvic Masses

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 GenetiX^SM 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

FAQ

What is OVASight and its performance metrics?

OVASight is a blood-based test developed for assessing the risk of ovarian cancer, achieving 89% specificity, 91% sensitivity, and a 99.6% negative predictive value.

When was the clinical data for OVASight presented?

The initial clinical data for OVASight was presented on June 3, 2021, during the ASCO 2021 virtual meeting.

What is the significance of the OVASight test for women’s health?

OVASight aims to provide better risk assessment for women with pelvic masses, allowing for more personalized and conservative management.

How does OVASight compare to CA-125 testing?

OVASight shows significantly better sensitivity in both overall and early-stage disease than CA-125 testing.

What population is the OVASight test validated for?

OVASight has been validated in a low prevalence population with a 3.8% rate of ovarian cancer.