Aspira Women's Health

What Aspira Women's Health does

Aspira Women's Health (formerly Vermillion, founded 2003, NASDAQ-to-OTCQX ticker AWHL) is an Austin, Texas-based diagnostics company that develops and commercializes AI-powered, blood-based tests for gynecologic disease risk assessment. Its marketed portfolio, branded as OvaSuite, consists of OvaWatch (a lab-developed test with >99% negative predictive value for ruling out ovarian cancer in women with indeterminate or benign-appearing adnexal masses) and Ova1Plus (a reflex combination of FDA-cleared Ova1 and Overa achieving 96% sensitivity when combined with clinical assessment). The underlying platform fuses protein biomarkers (including CA-125 and HE4) with microRNA markers licensed from Dana Farber Cancer Institute and clinical variables inside proprietary neural network and multivariate index algorithms; the Aspira Synergy distributed-testing platform extends these algorithms to partner laboratories running Roche Cobas ECLIA analyzers. Pipeline assets include ENDOinform (a non-invasive endometriosis blood test completing molecular lab buildout in Q2 2026) and OVAinform (a next-generation ovarian cancer test combining proteins and miRNAs).

Revenue is generated on a per-test basis, with a transparent $295 cash-pay price for uninsured or non-covered patients and direct billing to Medicare, Medicaid, and commercial insurers by Aspira Labs, the company's CLIA-certified, wholly-owned subsidiary. The go-to-market motion is sales-led, targeting OB-GYNs, gynecologic oncologists, and health systems through field sales, medical affairs outreach, peer-reviewed publications (60+), and a clinical advisory board. Channel expansion includes a Bio-Reference (Quest) co-marketing arrangement, a Dorsata clinical workflow partnership covering 300+ women's health practices representing 1.5M+ new patients, and a 12-month laboratory services agreement with UTMB Galveston. As of January 2026, the company carried negative EBITDA of approximately -$9.97M and was trading on OTCQX after delisting from Nasdaq in April 2025; it secured a $1.05M subordinated loan in January 2026 and is pursuing milestone-based funding of up to $10M via ARPA-H alongside a transformative Master Collaboration and License Agreement with Cleveland Clinic announced in May 2026.

Name

Aspira Women's Health

Legal name

Aspira Women's Health

Website

https://aspirawh.com

Company type

Public

Founded year

2003

Operating status

Operating

Headcount range

51–100 employees

Short description

Aspira Women's Health develops and commercializes AI-powered blood-based diagnostic tests, primarily OvaSuite (OvaWatch and Ova1Plus), for ovarian cancer risk assessment in women with adnexal masses, serving OB-GYNs, gynecologic oncologists, and health systems.

Ownership category

akta.pro rank

Product category

Women's Health Diagnostics

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (6215)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

akta.pro secondary industry

Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI)

Keywords

• Ovarian cancer diagnostics
• Women's health diagnostics
• Gynecologic blood tests
• Noninvasive cancer screening
• AI diagnostic platform

Headquarters

HQ city

Austin

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. Laboratory Diagnostic Testing Services: Aspira Labs performs OvaWatch and Ova1Plus tests and bills insurance companies including Medicare, Medicaid, and commercial insurers. Patients may have out-of-pocket costs for deductibles, copayments, and coinsurance under their insurance plans.
2. Direct Patient Billing: For uninsured patients or when tests are non-covered by insurance, Aspira offers self-pay rate of $295 per test. Financial assistance programs and interest-free payment plans are available for qualifying patients.

Pricing tiers

Go-to-market motion1 record

Distribution channels4 records

Marketing channels5 records

Core offering

Aspira Women's Health develops, commercializes, and performs laboratory testing for AI-powered, blood-based diagnostic tests focused on gynecologic oncology and women's health. Its flagship OvaSuite portfolio includes OvaWatch (for adnexal masses evaluated as indeterminate or benign) and Ova1Plus (combining Ova1 and Overa for masses planned for surgery). The company also operates a CLIA-certified laboratory (Aspira Labs) that processes specimens and bills insurance, and runs the Aspira Synergy platform that licenses its proprietary algorithms to partner laboratories.

Product overview

Aspira Women's Health offers OvaSuite℠, a comprehensive portfolio of non-invasive, AI-powered blood tests for gynecologic disease diagnostics. The portfolio includes two marketed products: OvaWatch® (for adnexal masses evaluated as indeterminate or benign, with 99% NPV) and Ova1Plus® (a reflex process combining FDA-cleared Ova1® and Overa® for masses planned for surgery, with 96% sensitivity). Both products utilize proprietary AI algorithms processing multiple biomarkers and clinical data to generate personalized risk scores. The pipeline includes OVAinform (next-generation ovarian cancer test combining proteins and miRNAs) and ENDOinform™ (non-invasive endometriosis blood test utilizing proteins, clinical factors, and miRNAs). The company also offers Aspira Synergy, a distributed lab platform enabling partner laboratories to run tests on Roche Cobas ECLIA analyzers.

Differentiator

Problem solved

Functional benefit

Brands

• OvaWatch: Non-invasive blood test to assess risk of ovarian cancer for women with adnexal masses initially evaluated as indeterminate or benign, with Negative Predictive Value over 99%.
• Ova1Plus
• ENDOinform
• OvaSuite
• Aspira Synergy

Products and services

• OvaWatch OvaWatch is a non-invasive, AI-powered blood test intended to assess the risk of ovarian cancer in patients with an adnexal mass initially evaluated as indeterminate or benign. It features a Negative Predictive Value over 99% and includes a longitudinal monitoring feature for ongoing risk assessment over time.
• Ova1Plus Ova1Plus is a proprietary reflex process combining two FDA-cleared tests (Ova1 and Overa) to detect the risk of ovarian malignancy in women with adnexal masses planned for surgery. It achieves 96% sensitivity when combined with clinical assessment and is supported by ACOG Level B guidelines.
• Ova1 Ova1 is the first FDA-cleared multivariate index assay for pre-surgical assessment of ovarian malignancy risk in women with pelvic masses planned for surgery. It has a Negative Predictive Value of 91% and 97% sensitivity for ovarian cancer, biased toward sensitivity.
• Overa Overa is the second-generation FDA-cleared biomarker test used as a reflex test within the Ova1Plus workflow for intermediate Ova1 results. It maintains high sensitivity while improving specificity with a Positive Predictive Value of 79%.
• ENDOinform ENDOinform is a next-generation, non-invasive, AI-powered blood test in development for endometriosis diagnosis. It is designed as a blood-based assay utilizing proteins, clinical factors, and miRNAs to aid in identification of all endometriosis including the 60% not attributed to endometriomas.
• OVAinform OVAinform is a next-generation AI-powered blood test in development to aid in identification of ovarian cancer in women diagnosed with an adnexal mass. It combines Aspira's protein biomarkers with miRNAs licensed from Dana Farber and clinical data in a proprietary algorithm.
• Aspira Synergy Aspira Synergy is a distributed laboratory platform that enables partner laboratories to run FDA-cleared Aspira tests locally using Roche Cobas ECLIA analyzers, providing access to proprietary machine-learning algorithms while maintaining flexibility for partner labs to validate and run tests in their own facilities.

Quantifiable outcome

• OvaWatch demonstrates >99% Negative Predictive Value, enabling confident rule-out of ovarian cancer in women with indeterminate or benign adnexal masses
• +4 more outcomes

Named customers2 records

Segments4 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability4 records

Feature5 records

Partnerships

Six partnerships are on record, tiered core and secondary.

• Cleveland CliniccoreStrategic or Co-development Partner · 26 May 2026Master Collaboration and License Agreement to jointly develop AI-powered diagnostics for women's health conditions including ovarian cancer and endometriosis. Collaboration encompasses biomarker discovery, data generation, translational development, intellectual property collaboration, and clinical research initiatives. Aspira CEO Mike Buhle described this as an inflection point for building a category-defining women's health diagnostics platform. Dr. Kevin Elias from Cleveland Clinic serves as co-lead alongside Aspira's Dr. Todd Pappas.
• Roche DiagnosticssecondaryTechnology or Integration · 1 January 2026Aspira Synergy platform enables partner laboratories to run FDA-cleared tests on Roche Cobas ECLIA analyzers. Transitioning ENDOinform development to BioRad ddPCR platform for scalability and efficiency.
• University of Texas Medical Branch at GalvestoncoreChannel Partner/ Reseller/ Distributor · 29 October 202512-month laboratory services agreement to expand reach for ovarian cancer diagnostic products. Agreement supports growth of revenues and improves go-to-market strategy by leveraging the partnership to reach more patients in Texas, one of the largest healthcare markets in the US.
• DorsatasecondaryGTM or Marketing Partner · 17 June 2025Partnership to offer clinical workflow tools for adnexal masses to 300+ women's health practices representing 1.5 million+ new patients. Integration of Aspira diagnostic tests into Dorsata's clinical decision support platform provides seamless workflow for providers managing adnexal masses.
• Quest Diagnostics / Bio-Reference LaboratoriessecondaryChannel Partner/ Reseller/ Distributor · 1 January 2024Distribution and co-marketing relationship for Ova1Plus through Bio-Reference Laboratories, one of the largest laboratory networks in the US, expanding market reach and accessibility of diagnostic tests.
• Dana Farber Cancer InstitutecoreTechnology or Integration · 1 January 2024Licensed miRNA biomarkers from Dana Farber under Sponsored Research Agreement for use in OVAinform next-generation ovarian cancer risk assessment and ENDOinform endometriosis diagnostic tests.

Scale indicators9 records

Recent moves9 records

Expansion highlights6 records

Direct peers

• Myriad Genetics: Myriad Genetics is a molecular diagnostics company specializing in hereditary cancer and women's health testing (e.g., BRACAnalysis, myChoice). Directly comparable as a women's health and oncology-focused diagnostic test provider with similar commercial dynamics around OB-GYN and oncology specialists.
• Veracyte: Veracyte is a genomic diagnostics company developing molecular tests for cancer (urologic, thyroid, breast). Directly comparable in developing and commercializing proprietary molecular diagnostic tests targeting specific oncology indications with similar biomarker-plus-algorithm architecture.
• NeoGenomics: NeoGenomics operates a network of CLIA-certified oncology-focused clinical laboratories providing cancer diagnostic testing services. Comparable as a specialty oncology diagnostic laboratory with similar business model of biomarker testing and oncology-focused commercial channels.
• Natera: Natera is a molecular diagnostics company with strong positions in reproductive health (cell-free DNA testing) and oncology. Comparable in combining proprietary AI/ML algorithms with biomarker-based testing, and in addressing women's health and oncology markets via specialty sales channels.

Broad incumbents

• Exact Sciences: Exact Sciences is a leading cancer diagnostics company anchored by Cologuard. Comparable as a publicly-traded cancer diagnostics company with proprietary biomarker tests and direct physician sales channels, though significantly larger and broader in scope.
• Hologic: Hologic is a major women's health company with diagnostics products including ThinPrep cytology and molecular assays. Comparable in targeting OB-GYNs and women's health channels, though operating at much greater scale across a broader women's health portfolio.
• Quest Diagnostics: Quest Diagnostics is the largest US clinical reference laboratory, distributing Aspira's Ova1Plus through Bio-Reference. Comparable as the dominant US lab services and women's health diagnostics provider; serves as both distribution partner and large incumbent competitive threat.
• Laboratory Corporation of America (LabCorp): LabCorp is one of the largest US clinical reference laboratories with extensive women's health and oncology diagnostic offerings. Comparable as a broad incumbent in clinical laboratory services with established OB-GYN and oncologist relationships that could compete with or distribute Aspira's tests.

Emerging players

• Guardant Health: Guardant Health is a liquid biopsy-focused cancer diagnostics company using proprietary blood-based biomarker testing with AI/ML analytics. Comparable in combining multiomic biomarker analysis with proprietary algorithms to deliver blood-based oncology diagnostics, though primarily focused on solid tumor monitoring.

Others

• Bio-Techne: Bio-Techne is a life sciences tools and diagnostics company providing biomarker reagents and diagnostic test components. Comparable as an adjacent technology and reagents provider serving diagnostic test developers and clinical laboratories in the women's health and oncology space.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/AspiraWH
• Facebookfacebook.com/aspirawomenshealth

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries1 record

Funding overview

Funding rounds10 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aspira Women's Health