AWH: Update on Noninvasive Endometriosis Test Portfolio

Data supports EndoCheck™ to be the first blood test for the identification of localized endometriosis, including endometrioma

Platform migration to begin on the Company’s EndoMDx™ test for broader endometriosis indications

AUSTIN, Texas, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced that it has completed the design of EndoCheck based on the analysis of samples received from The University of Oxford in October. Data show EndoCheck to be a high-performing blood test for localized endometriosis, including ovarian endometriosis masses known as endometrioma. The Company is collaborating with The University of Oxford on an abstract for presentation and a manuscript for publication to support a commercial launch in 2024. Independent verification of the EndoCheck test for endometriomas, the next step in its development, will begin shortly with data to be provided by The Dana Farber Cancer Institute.

Endometrioma is a localized form of endometriosis that has formed an ovarian mass. It is one of the most common types of endometriosis. All endometriosis, including endometriomas, are currently diagnosed through invasive laparoscopic surgery. Performance of the EndoCheck test is expected to be sufficient to offer a non-invasive clinical alternative to laparoscopic surgery for endometriomas.

Up to 44% 1 of patients with endometriosis of all stages are found to have an endometrioma. With over 6 million women in the U.S. estimated to be suffering from endometriosis, the addressable market for the non-invasive test for identifying endometrioma is estimated by the Company to be up to 2.5 million. The Company plans to expand the intended use of the test in other forms of endometriosis through additional research to further increase EndoCheck’s addressable market.

“EndoCheck builds upon our unique know-how with AI machine learning and knowledge of gynecologic disease, which are the hallmark of our tests,” said Nicole Sandford, President, and CEO of Aspira. “This is an incredibly complex disease, and the development of the test has taken longer than expected. Nonetheless, we are excited to have a test with such a clear signal - a truly first-of-its kind accomplishment. Our next priority is to ensure a successful commercial launch through a thoughtful introduction of EndoCheck into the payor and provider markets in 2024. We are working with our Clinical Advisory Board and our network of academic and clinical collaborators to do just that.”

EndoCheck was developed on an FDA-cleared platform in the Company’s CLIA laboratory, which will support a rapid launch as a Lab Developed Test upon completion of the remaining validation steps, assessment of the commercial application, and publication of a peer reviewed manuscript.

In addition to EndoCheck, the Company has continued its progress with the development of EndoMDx which incorporates miRNA, proteins, and clinical characteristics to identify all types and locations of endometriosis. Aspira is developing EndoMDx through a sponsored research agreement with a consortium of world-class academic and research institutions led by The Dana Farber Cancer Institute. Platform migration and test validation of a proprietary EndoMDx signature, delivered earlier this year, is underway. Aspira believes samples from The Dana Farber Cancer Institute, its existing endometriosis biobank, and the ongoing EndoCheck Clinical Study will be sufficient to complete design and development of EndoMDx in 2024.

Dr. Jody Berry, Chief Scientific Officer of Aspira, noted, “Our knowledge and understanding of endometriosis grows every day. With its complex spectrum of phenotypes, the successful development of noninvasive methods to identify all presentations of endometriosis will require a portfolio approach. We are excited that data show our EndoCheck test to be highly effective in identifying localized ovarian endometriosis and expect development for a broader indication to accelerate now that the design of a potentially high performing EndoMDx signature is complete.”

Ms. Sandford concluded, “Our progress has generated renewed interest in our approach and scientific achievements. We are accelerating our conversations with potential partners in the industry that can further our strategic options and drive long-term shareholder value. I am proud of the advancements we have made and look forward to sharing more details with investors at an Analyst Day event in January 2024.”

About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. is transforming women’s gynecological health with the discovery, development, and commercialization of innovative testing options for women of all races and ethnicities, starting with ovarian cancer. Our ovarian cancer risk assessment portfolio is marketed to healthcare providers as OvaSuite SM , which includes OvaWatch SM , a non-invasive, blood-based test intended for use in the initial clinical assessment of ovarian cancer risk in women with benign or indeterminate adnexal masses for which surgical intervention may be either premature or unnecessary. With a negative predictive value (NPV) of 99%, OvaWatch allows physicians to confidently rule out ovarian cancer malignancy and choose the appropriate clinical management for the right patient at the right time. Ova1Plus ® combines our FDA-cleared products, Ova1 ® and Overa ® , to detect risk of ovarian malignancy in women with adnexal masses planned for surgery.

EndoCheck SM , Aspira’s first-of-its-kind non-invasive diagnostic test for endometriosis, is currently in development. Visit our website for more information at www.aspirawh.com .