OPK Opko Health Inc

Aspira Women’s Health Inc. (“Aspira”) (NASDAQ: AWH), a bio-analytical based women’s health company focused on the development of gynecologic disease diagnostic tools, today announced the expansion of its co-marketing and distribution collaboration with BioReference Health, LLC (“BioReference”), a wholly-owned subsidiary of OPKO Health Inc. (NASDAQ: OPK), a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets.

Under the terms of the expanded agreement, Aspira and BioReference will join forces to market Aspira’s complete OvaSuite portfolio, including OvaWatch® and Ova1Plus®, to BioReference women’s healthcare provider clients. BioReference and Aspira have co-marketed and distributed Ova1Plus since 2022. The approval of OvaWatch by the New York State Department of Health’s (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) in early October paved the way for the expanded relationship by making it available to the 15+ million women in New York and New Jersey.

Nicole Sandford, CEO of Aspira, expressed her enthusiasm for the expanded alliance, highlighting the shared goal of improving healthcare for women and the potential to accelerate OvaWatch adoption in New York and New Jersey without incurring additional costs.

Ellen Beausang, Chief Commercial Officer of BioReference, shared the excitement, emphasizing how the addition of OvaWatch to the Women's Health portfolio underscores BioReference Health's commitment to offering top-tier testing to aid women's health providers in New York and New Jersey in managing patients and helping improve patient outcomes.

About BioReference Health BioReference® Health, LLC, empowers confident healthcare decisions by prioritizing service, creating innovative solutions, and offering scientific expertise in diagnostic testing. BioReference is headquartered in Elmwood Park, New Jersey, and is in-network with the largest health plans in the United States and processed more than 9 million tests in 2023. BioReference provides credible and tailored solutions for a variety of customers and patients, including medical practices small and large, hospitals and health systems, correctional institutions, and government agencies. In addition to an extensive test menu with 99 percent of tests performed in-house, BioReference’s differentiated offerings include large-scale health screening programs and transformative business solutions that optimize laboratory management. For more information, visit https://www.bioreference.com or on Facebook, Twitter, Instagram and LinkedIn.

About OvaWatch®   OvaWatch is the only non-invasive blood test available to assess the risk of ovarian cancer in patients with an adnexal mass initially evaluated as indeterminate or benign. With a 99% negative predictive value and longitudinal monitoring feature, OvaWatch allows physicians and patients to determine a personalized monitoring or treatment. 

About Aspira Women’s Health Inc.  Aspira Women’s Health Inc. is dedicated to the discovery, development, and commercialization of noninvasive, AI-powered tests to aid in the diagnosis of gynecologic diseases.    

OvaWatch® and Ova1Plus® are offered to clinicians as OvaSuiteSM. Together, they provide the only comprehensive portfolio of blood tests to aid in the detection of ovarian cancer risk for the 1.2+ million American women diagnosed with an adnexal mass each year. OvaWatch provides a negative predictive value of 99% and is used to assess ovarian cancer risk for women where initial clinical assessment indicates the mass is indeterminate or benign, and thus surgery may be premature or unnecessary. Ova1Plus is a reflex process of two FDA-cleared tests, Ova1® and Overa®, to assess the risk of ovarian malignancy in women with an adnexal mass planned for surgery.     

Our in-development test pipeline will expand our ovarian cancer portfolio and address the tremendous need for non-invasive diagnostics for endometriosis, a debilitating disease that impacts millions of women worldwide. In ovarian cancer, we intend to combine microRNA and protein biomarkers with patient data to further enhance the sensitivity and specificity of our current tests. In endometriosis, we have developed the first-ever non-invasive test designed to identify endometriomas, one of the most commonly occurring forms of severe endometriosis. Through our ongoing endometriosis development program, we are combining microRNA and protein biomarkers with patient data, with the intent of identifying all endometriosis independent of disease location or severity.

Forward-Looking Statements  This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve a number of risks and uncertainties. Such forward-looking statements include statements regarding, among other things, the timing and completion of any products in the pipeline development and other statements that are predictive in nature and whether the collaboration and marketing of the OvaSuite portfolio will prove successful. Actual results could differ materially from those discussed due to known and unknown risks, uncertainties, and other factors. These forward-looking statements generally can be identified by the use of words such as “designed to,” “expect,” “plan,” “anticipate,” “could,” “may,” “intend,” “will,” “continue,” “future,” other words of similar meaning and the use of future dates. These and additional risks and uncertainties are described more fully in the Company’s filings with the SEC, including those factors identified as “Risk Factors” in our most recent Annual Report on Form 10-K, for the fiscal year ended December 31, 2023, and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or our assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that Aspira presently does not know, or that Aspira currently believes are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect Aspira’s expectations, plans, or forecasts of future events and views as of the date of this press release. Subsequent events and developments may cause the Company’s assessments to change. However, while Aspira may elect to update these forward-looking statements at some point in the future, Aspira expressly disclaims any obligation to do so, except as required by law. These forward-looking statements should not be relied upon as representing Aspira’s assessments of any date after the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. 

Investor Relations Contact:  Jamie SullivanDirector of Corporate CommunicationsAspira Women’s HealthInvestors@aspirawh.com