Arizona Tribune - Aspira Women's Health (OTCQB:AWHL) Enters Key Growth Phase with Molecular Lab Expansion to Accelerate Breakthrough Endometriosis Blood Test ENDOinform(TM)

This expansion represents a critical step toward scale, enabling Aspira to advance clinical validation, enhance assay performance, and position the Company for broader market penetration within a multi-billion-dollar diagnostic opportunity.

"The expansion of our molecular laboratory represents a pivotal milestone for Aspira and accelerates our path forward with ENDOinform^™," said Mike Buhle, Chief Executive Officer of Aspira Women's Health. "We are addressing a major unmet need affecting millions of women, and we believe our AI-driven, multiomic approach has the potential to redefine the diagnostic landscape. Just as importantly, this step strengthens our ability to scale and execute as we move toward commercialization."

Endometriosis is a chronic, often debilitating condition that affects millions of women and is associated with pelvic pain, infertility, reduced quality of life, and substantial healthcare burden. According to the U.S. Department of Health and Human Services, endometriosis affects more than 6.5 million women in the United States. Despite its prevalence, diagnosis frequently depends on invasive procedures or prolonged clinical evaluation, highlighting the need for a reliable, noninvasive diagnostic alternative.

Aspira's ENDOinform^™ is designed to directly address this need through a first-of-its-kind multiomic, AI-powered blood test, integrating:

• Serum protein biomarkers

• microRNA signatures

• Clinical metadata

This differentiated approach is intended to deliver higher diagnostic accuracy and earlier detection, potentially transforming how endometriosis is identified and managed.

Aspira is building meaningful momentum in its clinical program, with:

• Analysis of dozens of protein, miRNA and clinical metadata features from over 400 prospectively-collected intended-use patient samples

• 1000+ clinically relevant patients enrolled in prospective studies to power additional verification and validation

• Ongoing refinement of its multiomic model to maximize performance

This expanding dataset is expected to drive validation milestones and increase confidence in clinical utility, representing key steps toward commercialization.

The Company believes the growing number of commercially available and in-development therapeutics for endometriosis may further increase the need for noninvasive tools that can facilitate earlier identification, patient stratification, and treatment decision-making. As interest in precision medicine continues to expand across women's health, Aspira believes ENDOinform^™ has the potential to become an important component of the future diagnostic pathway for endometriosis.

To support development and potential commercialization, Aspira is transitioning the program onto a clinical digital PCR platform designed for scalability, reproducibility, and operational efficiency. The Company believes this enhanced molecular infrastructure will support both the advancement of ENDOinform^™ and broader synergies across Aspira's diagnostic portfolio, while aligning assay innovation with the practical requirements of clinical laboratory deployment.

The ENDOinform^™ program reflects Aspira's broader strategy to combine biomarker science, computational analytics, and scalable laboratory infrastructure to develop evidence-based diagnostics in areas of high unmet need. The Company believes this approach reinforces its position at the intersection of women's health, multiomic innovation, and AI-enabled clinical decision support.

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 OvaSuite^SM.

OvaWatch^® and Ova1Plus^® are offered to clinicians as OvaSuite^SM. 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 development pipeline and other statements that are predictive in nature, and whether the 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," and 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, 2024, 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:

Jenene Thomas
CEO, JTC IR
[email protected]
(908) 824-0775

SOURCE: Aspira Women's Health

View the original press release on ACCESS Newswire

O.Brown--AT