Aspira Women’s Health Advances in Women’s Health Diagnostics
Released: June 11, 2025
Grant Update from ARPA-H
Aspira Women’s Health Inc. (OTCQB: AWHL), based in Austin, TX, and Washington, DC, has announced a significant update on its ongoing research funded by the Advanced Research Projects Agency for Health (ARPA-H). The program, known as the Sprint for Women’s Health, aims to address crucial unmet needs in women’s health diagnostics.
The company was previously awarded $10 million to support the development of its ENDOinform test, an innovative diagnostic tool that utilizes a non-invasive blood draw to employ a multi-omics approach. This technology leverages protein and microRNA biomarkers, alongside patient-specific data, to facilitate accurate endometriosis diagnosis.
Progress and Milestones
The ENDOinform test draws on technology initially developed for ovarian cancer diagnostics, boasting the potential to non-invasively confirm the presence of endometriosis. This capability enables healthcare providers to better identify patients who might benefit from existing endometriosis treatment options.
Aspira received the first two payments of the grant—$2 million and $1.5 million—on November 29, 2024, and March 28, 2025, respectively, totaling $3.5 million thus far. However, on June 9, 2025, ARPA-H notified Aspira that it had not met the criteria for Milestone 3, leading to the termination of the ENDOinform development program contract.
CEO Response
Mike Buhle, CEO of Aspira, expressed disappointment over the termination notice but maintained confidence in the company’s compliance with Milestone 3 requirements. “We achieved these requirements in early May and are well underway in achieving Milestone 4 targeted specifications,” he stated. His remarks highlight the team’s belief in their quality of work and technical expertise concerning the ENDOinform program.
Buhle further emphasized the excitement within the R&D team regarding the project’s progress and potential outcomes, stating, “ENDOinform promises a dramatic improvement in health outcomes and quality of life for millions of women suffering from endometriosis.” Aspira plans to continue the development of this vital program, aiming for completion by 2026.
About Aspira Women’s Health Inc.
Aspira is dedicated to the development of non-invasive, AI-enhanced tests aimed at diagnosing gynecologic diseases. Their portfolio includes OvaWatch® and Ova1Plus®, available as OvaSuiteSM, offering comprehensive blood tests to assess ovarian cancer risk for over 1.2 million women diagnosed with an adnexal mass annually in the U.S.
- OvaWatch provides a 99% negative predictive value for evaluating ovarian cancer risk in cases where initial assessments are inconclusive.
- Ova1Plus combines two FDA-cleared tests to determine malignancy risk in women with adnexal masses undergoing surgery.
The company also focuses on expanding its diagnostic capabilities in endometriosis, incorporating both microRNA and protein biomarkers to enhance detection accuracy.
Forward-Looking Statements
This announcement contains forward-looking statements as outlined in the Private Securities Litigation Reform Act of 1995. These statements involve various risks and uncertainties and may include projections regarding the timeline and success of product developments. Actual outcomes could differ significantly, and potential investors should carefully review the risks detailed in the company’s SEC filings.
