Aspira Women’s Health to Reveal 3rd Generation Ovarian Cancer Risk Assessment Technology at ASCO 2021

Rhea-AI Summary

Aspira Women’s Health (Nasdaq: AWH) announced the analytical and initial clinical validation of its OVASight™ blood-based biomarker test for assessing ovarian malignancy risk in women with adnexal masses. The abstract detailing this test will be presented at the ASCO 2021 meeting from June 4-8. The OVASight™ test showcases a high negative predictive value, enhancing clinician confidence in monitoring suspected benign masses. The product is expected to be available in Q4 2021, aiming to replace the CA-125 test.

Positive

• Analytical validation performance for OVASight™ presented at ASCO 2021.
• High negative predictive value, enhancing confidence in managing benign masses.
• Expected product availability in Q4 2021.

Negative

• Low prevalence population (<5%) may limit the broader applicability of results.

-   Analytical and Initial Clinical Validation performance for Aspira’s OVASight™ 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 (GLOBE NEWSWIRE) -- 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 4-8, 2021.

The accepted abstract presents data demonstrating the analytical validation performance with initial clinical validity data of Aspira’s OVASight™ 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 OVA1plus™, 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

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 includes our FDA-cleared products, OVA1® and OVERA®, to detect risk of ovarian malignancy in women with adnexal masses. ASPIRA GenetiX™ testing offers both targeted and more comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health is delivering a portfolio of pelvic mass products over a patient’s lifetime with our cutting-edge research. 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 the purpose of Aspira's OVASight™ test announced on May 13, 2021?

The OVASight™ test is designed for ovarian malignancy risk assessment in women with adnexal masses.

When will Aspira's OVASight™ test be available?

The OVASight™ test is expected to be available in Q4 2021.

What was presented at the ASCO 2021 meeting regarding Aspira?

An abstract detailing the analytical validation and initial clinical performance of the OVASight™ test was presented.

What does high negative predictive value mean for the OVASight™ test?

It indicates greater confidence for clinicians when managing or monitoring suspected benign masses.

What is the prevalence of malignancy detection in the study for OVASight™?

The study utilized a low prevalence population with less than 5% malignancy detection.