Aspira Women’s Health Inc. Announces Coverage for OVA1® in the AIM Specialty Health Laboratory Medicine Clinical Guidelines

Rhea-AI Summary

Aspira Women’s Health Inc. (Nasdaq: AWH) announced that its OVA1® ovarian cancer risk assessment test is now deemed medically necessary per AIM Specialty Health's guidelines.

This move enhances access for women with pelvic masses and aligns with AIM's efforts to improve healthcare quality. Positive coverage expansions, such as New York State Medicaid, have increased access to OVA1® technology. CEO Valerie Palmieri emphasized the commitment to improving care standards for women.

Positive

• OVA1® test classified as medically necessary by AIM Specialty Health.
• Increased accessibility for women with pelvic masses following guideline updates.
• Positive coverage additions, including New York State Medicaid, expanding patient access.
• Recognition of superior clinical performance compared to CA125 markers.

Negative

• None.

AIM is a wholly owned subsidiary of Anthem, Inc., serving more than 50 million members across 50 states, D.C., and US territories.

AUSTIN, Texas, July 08, 2021 (GLOBE NEWSWIRE) -- Aspira Women’s Health Inc. (Nasdaq: AWH) today announced its OVA1^® risk assessment test for ovarian cancer in women with pelvic masses is considered medically necessary according to AIM Specialty Health’s Clinical Appropriateness Guidelines. AIM Specialty Health is a member of the Anthem Blue Cross Blue Shield family of companies and serves as a specialty benefits management company working with many of the nation’s largest health care organizations. AIM’s mission is to promote appropriate, safe, and affordable health care. As one of the nation’s leading specialty benefits management firms, AIM helps improve the quality of care and reduces the cost for many of the most complex tests and treatments.

The OVA1^® test is now included in AIM’s guidelines for the preoperative evaluation of an adnexal mass when it is indeterminate based on clinical and complete pelvic ultrasound evaluation. The guidelines also include OVA1^® for the determination of the required surgical approach, operator expertise and level of care for an adnexal mass.

Recent positive coverage additions for OVA1^®, such as New York State Medicaid, coupled with peer-reviewed publications documenting OVA1^®’s superior clinical performance as compared to CA125, especially among Black women, has resulted in a dramatic increase in the number of women who have access to the OVA1^® technology. Aspira Labs, Inc., a subsidiary of Aspira Women’s Health, is the only U.S. provider for Aspira’s proprietary OVA1^® test, an FDA-cleared, ACOG recommended, and Medicare covered ovarian cancer risk assessment tool for women with a pelvic mass.

“We are excited to provide access to OVA1plus^TM, to such a large segment of the population,” said Valerie Palmieri, President and CEO of Aspira Women’s Health Inc. “This guideline from an organization with a robust technology assessment process expands our ability to truly change the standard of care and helps advance our commitment to making OVA1^® accessible to ALL women.”

About Aspira Women’s Health Inc.
Aspira Women’s Health Inc. (formerly known as Vermillion, Inc., Nasdaq: VRML) is transforming women’s health with the discovery, development, and commercialization of innovative testing options and bio-analytical solutions that help physicians assess risk, optimize patient management, and improve gynecologic health outcomes for women. Aspira Women’s Health is particularly focused on closing the ethnic disparity gap in ovarian cancer risk assessment and developing solutions for pelvic diseases such as pelvic mass risk assessment and endometriosis. OVA1plus^TM combines our FDA-cleared products, OVA1^® and OVERA^®, to detect risk of ovarian malignancy in women with adnexal masses. [Aspira GenetiX^TM] testing offers both targeted and more comprehensive genetic testing options with a gynecologic focus. With over 10 years of expertise in ovarian cancer risk assessment, Aspira Women’s Health is delivering a portfolio of pelvic mass products over a patient’s lifetime with our cutting-edge research. The next generation of products in development are [OVASight^TM and EndoCheck^TM]. Visit our website for more information at www.aspirawh.com.

Investor Relations Contact:
Ashley R. Robinson
LifeSci Advisors, LLC
Tel 617-430-7577
Arr@lifesciadvisors.com

FAQ

What did the AIM Specialty Health guidelines update mean for Aspira Women's Health?

The update classified the OVA1® test as medically necessary, enhancing its accessibility for women with pelvic masses.

How does the OVA1® test compare to other ovarian cancer risk assessments?

OVA1® has demonstrated superior clinical performance compared to CA125, particularly among Black women.

What recent coverage expansions have benefitted OVA1®?

Recent expansions include coverage by New York State Medicaid, increasing access for eligible patients.

What is the significance of OVA1® being included in AIM's guidelines?

Inclusion in AIM's guidelines promotes appropriate healthcare access and determines necessary surgical approaches for adnexal masses.

Who is the current CEO of Aspira Women's Health?

Valerie Palmieri serves as the President and CEO of Aspira Women's Health Inc.