Aspira Women's Health AWHL

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, starting with ovarian cancer. The company's main business activities involve creating blood-based diagnostic assays that combine biomarkers such as serum proteins and microRNA with clinical data to assess malignancy risk in women with adnexal masses. It operates within the in vitro diagnostics industry, focusing on improving early detection and monitoring of ovarian cancer and developing tests for endometriosis. Aspira aims to expand access to its tests through direct sales and laboratory partnerships while advocating for broader adoption in clinical guidelines and insurance coverage.

The company generates revenue primarily through the sale of its Ova1Plus workflow and OvaWatch test, which are performed at its CLIA-certified laboratory, Aspira Labs, in Austin, Texas. Revenue comes from third-party payers including Medicare and Medicaid, private insurance companies, client bill arrangements, and direct patient payments. Aspira Labs bills for Ova1 and OvaWatch using specific CPT and PLA codes, with reimbursement rates established through Medicare Administrative Contractors such as Novitas Solutions. The Ova1Plus workflow uses Ova1 as a primary test and Overa as a reflex test for intermediate results, while OvaWatch is used for initial and periodic assessment of malignancy risk in indeterminate or benign adnexal masses. These products are distributed through Aspira's direct national sales force and channel partnerships with laboratories such as BioReference Health, ARUP, and Mayo Clinic Laboratories.

The company operates through the following segments:

• Ovarian Cancer: This segment focuses on the development and commercialization of noninvasive blood tests for assessing ovarian cancer risk in women with adnexal masses. Key products in this segment include the Ova1Plus workflow, which combines the Ova1 and Overa tests, and the OvaWatch test for monitoring malignancy risk over time. The Ova1 test received FDA de novo classification in September 2009, and Overa received FDA 510(k) clearance in March 2016, both using the Roche Cobas platform for protein analysis.
• Endometriosis: This segment is dedicated to creating a non-invasive diagnostic test for endometriosis, a condition affecting approximately 10% of reproductive-age women in the United States. The ENDOinform program is developing a multi-marker test that combines serum proteins, microRNA, and clinical data to improve detection of endometriosis. Aspira is conducting the EndoCheck observational clinical study to support the validation of ENDOinform, with enrollment ongoing through 2025 and completion expected in 2026.

Aspira Women's Health Inc. holds a competitive position in the gynecologic diagnostics industry due to its expertise in multivariate index assays and experience with FDA-cleared products like Ova1 and Overa. The company competes with firms such as Fujirebio Diagnostics (which offers the ROMA test), Exact Sciences, Grail, and various academic and private entities developing ovarian cancer and endometriosis diagnostics. Its competitive advantages include proprietary algorithms, clinical validation data, established relationships with key opinion leaders in women's health, and a direct sales force that educates physicians on the clinical utility of its tests. Aspira's ability to combine multiple biomarkers with AI-powered analysis provides improved sensitivity and specificity compared to single-marker tests like CA-125.

The company's customer base includes physicians, physician office laboratories, and national and regional laboratories across the United States. Specific channel partners that distribute Aspira's tests include BioReference Health, LLC, Associated Regional University Pathologists (ARUP), and Mayo Clinic Laboratories, which began distributing Ova1 and OvaWatch under an agreement executed in December 2025. Aspira also works with Quest Diagnostics through a long-standing agreement for specimen transport and logistics. Clinical specimens are sent directly to Aspira Labs for testing, and the company bills third-party payers or clients through client bill arrangements depending on the testing pathway.