Data showed miRNA-protein models potential to improve the diagnostic accuracy of non-invasive ovarian cancer tests
October 25, 2023 08:00 ET
AUSTIN, Texas, Oct. 25, 2023 (GLOBE NEWSWIRE) — Aspira Women’s Health Inc. (“Aspira” or “the Company”) (Nasdaq: AWH), a bio-analytical company focused on the development and commercialization of women’s health diagnostic tools for gynecologic diseases today announced that a poster on an in-development miRNA-based ovarian cancer test was presented at the AACR Special Conference in Cancer Research: Ovarian Cancer, held on October 5, 2023 in Boston, MA. The test is expected to be launched as a part of the Company’s OvaSuite portfolio in collaboration with a consortium of world-renowned academic researchers under a previously announced licensing agreement.
The poster, entitled: “Improving the diagnostic accuracy of an ovarian cancer triage test using a joint miRNA-protein model,” highlighted data showing miRNA’s potential to improve the diagnostic accuracy of non-invasive diagnostic tests. Senior author, Dr. Kevin Elias M.D., Director, Gynecologic Oncology Laboratory at Brigham and Women’s Hospital and Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, has been investigating the role of miRNA in ovarian cancer and the role of serum miRNA as a diagnostic. The study combined serum protein and patient clinical information (metadata) from Aspria’s ovarian cancer registry studies with miRNA determined by the Elias laboratory.
The study showed the addition of miRNA improved the detection of early-stage ovarian cancers, and that diagnostic performance improved even further when using a combination of approaches, including miRNA, proteins and metadata. The data suggest that using combined approaches could improve the triaging of patients with suspected ovarian cancers.
“These data are very exciting and show the potential of miRNAs as a powerful tool in improving a number of diagnostic tests,” said Dr. Elias.
Nicole Sandford, President and Chief Executive Officer of Aspira Women’s Health said, “We are very pleased to see such promising initial findings from our collaboration with the Dana-Farber Cancer Institute. The analysis shows the potential for improving ovarian cancer diagnostics by combining our trusted technology with miRNA. It is exactly findings like these that give us hope that one day we will be able to detect ovarian cancer before it has progressed to its deadliest stages.”
A copy of the poster can be found on the Research and Professional Guidelines section under Providers of the Aspira Women’s Health corporate website.
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 OvaSuiteSM, which includes OvaWatchSM, 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. EndoCheckSM, 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.
This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, including statements regarding the potential effects of widespread use of OvaWatch and the availability of OvaWatch in New York. Forward-looking statements involve a number of risks and uncertainties. Words such as “may,” “expects,” “intends,” “anticipates,” “believes,” “estimates,” “plans,” “seeks,” “could,” “should,” “continue,” “will,” “potential,” “projects” and similar expressions are intended to identify forward-looking statements. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties, and assumptions, including those described in the section entitled “Risk Factors” in Aspira’s Annual Report on Form 10-K for the year ended December 31, 2022, and as supplemented in Aspira’s 10-Q filings for the quarter ended March 31, 2023, and June 30, 2023. These risks include, but are not limited to: our ability to continue as a going concern; our ability to comply with Nasdaq’s continued listing requirements; impacts resulting from potential changes to coverage of Ova1 through our Medicare Administrative Carrier for Ova1; impacts resulting from or relating to the COVID-19 pandemic and actions taken to contain it; anticipated use of capital and its effects; our ability to increase the volume of our product sales; failures by third-party payers to reimburse for our products and services or changes to reimbursement rates; our ability to continue developing existing technologies and to develop, protect and promote our proprietary technologies; plans to develop and perform laboratory developed tests; our ability to comply with Food and Drug Administration (“FDA”) regulations that relate to our products and to obtain any FDA clearance or approval required to develop and commercialize medical devices; our ability to develop and commercialize additional diagnostic products and achieve market acceptance with respect to these products; our ability to compete successfully; our ability to obtain any regulatory approval required for our future diagnostic products; or our suppliers’ ability to comply with FDA requirements for production, marketing and post-market monitoring of our products; our ability to maintain sufficient or acceptable supplies of immunoassay kits from our suppliers; in the event that we succeed in commercializing our products outside the United States, the political, economic and other conditions affecting other countries; changes in healthcare policy; our ability to comply with the additional laws and regulations that apply to us in connection with the operation of Aspira Labs; our ability to use our net operating loss carryforwards; our ability to use intellectual property; our ability to successfully defend our proprietary technology against third parties; our ability to obtain licenses in the event a third party successfully asserts proprietary rights; the liquidity and trading volume of our common stock; the concentration of ownership of our common stock; our ability to retain key employees; our ability to secure additional capital on acceptable terms to execute our business plan; business interruptions; the effectiveness and availability of our information systems; our ability to integrate and achieve anticipated results from any acquisitions or strategic alliances; future litigation against us, including infringement of intellectual property and product liability exposure; and additional costs that may be required to make further improvements to our laboratory operations. The events and circumstances reflected in Aspira’s forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Aspira expressly disclaims any obligation to update, amend or clarify any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
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