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

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Who We Are

Aspira Women's Health is dedicated to improving women’s lives starting with ovarian cancer. Through the discovery, development, and utilization of innovative testing options and bioanalytical solutions that help physicians assess risk and optimize patient management we improve health outcomes for women.

Our Products Are Clinically Valid and FDA-cleared  

OVA1® and OVERA® are FDA-cleared blood tests with unparalleled abilities to assess ovarian cancer risk in women with an adnexal mass who are planned for surgery. OVA1plusTM is a reflex process that first performs OVA1® and if the result is in the intermediate range, it then performs OVERA® to further qualify the risk.

It is important to remember CA125 is not FDA-cleared for presurgical risk assessment. Additionally, OVA1® is significantly more sensitive than CA125 and better at assessing risk of early stage ovarian cancer.1 OVA1® is also more effective at assessing risk of ovarian cancer in African-American women.2

OVA1 vs CA125 Chart

The FDA-cleared intended use for OVA1® and OVERA® is for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. OVA1® is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The test is not intended as a screening or stand-alone diagnostic assay.

Our tests are only run by Aspira Women’s Health in a specialty laboratory in Austin, Texas, which allows for maximum quality and control.

Professional Society and Payer Support

Clinical practice bulletins, position statements, and recommendations set forth by professional societies and payers support the use of a Multivariant Index Assay (MIA) such as OVA1®.

ACOG Practice Bulletin

The American College of Obstetricians and Gynecologists (ACOG) is the premier professional membership organization for this medical specialty.

The AGOG Level B Practice Bulletin 174 states that “Consultation with or referral to a gynecologic oncologist is recommended for women with an adnexal mass who meet one or more of the following criteria: Premenopausal or postmenopausal women with an elevated score on a formal risk assessment test such as the multivariate index assay.”3

SGO Position Statement

The Society of Gynecologic Oncology (SGO) is a medical specialty organization of physicians, surgeons, and healthcare professionals trained in the comprehensive management of women with reproductive tract malignancies.

SGO states that, “Tests monitoring blood levels of five proteins may be useful in identifying women with an ovarian mass who should be referred to a gynecologic oncologist.”4

AIM 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 healthcare organizations.

AIM notes that, “evidence is sufficient to recommend OVA1® for use as a risk-stratification tool in patients with an adnexal mass when surgery is planned.”5

eviCore Health

eviCore Health provides diversified medical management solutions for health plans. It focuses on improving patient outcomes and reducing waste with evidenced-based decision making.

eviCore notes that, “Coverage for OVA1® will be granted when the following criteria are met – surgery is planned, there has been no previous OVA1® testing, the patient is over 18 years old, has not yet been referred to a gynecologic oncologist and the rendering laboratory is a qualified provider of service per the Health Plan policy.”6

Medicare coverage

Additionally, OVA1® is covered by Medicare under LCD (L35396) biomarkers for oncology.7

Why You Should Provide Coverage for Our Tests

Our tests can save lives and reduce financial burden on the healthcare system. The overall 5-year survival rate of women diagnosed with ovarian cancer is only 49.1%.8 The deadly nature of this disease is due to all too frequent late stage diagnosis, which results in years of aggressive treatment and significant financial costs for patients and the healthcare system.9

We must act now to eradicate late stage diagnosis of ovarian cancer and ensure we do everything possible to improve health outcomes of patients as well as reduce unnecessary costs to the healthcare system.

Please fill out the form below if you would like to speak to someone on our team and request detailed dossier information. 

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Clinical Studies


  • Friedrich L, Meyer R, Levin G. Management of adnexal mass: a comparison of five national guidelines. Eur J Obstet Gynecol Reprod Biol. 2021265:80-89. doi:10.1016/j.ejogrb.2021.08.020. https://pubmed.ncbi.nlm.nih.gov/34474226/  
  • Dunton C, Hutchcraft M, Bullock R, et al. Salvaging detection of early-stage ovarian malignancies when CA125 is not informative. Diagnostics.  2021;11(8):1440. doi: 10.3390/diagnostics11081440 https://pubmed.ncbi.nlm.nih.gov/34441373/  
  • Dunton C, Eskander R, Bullock R, et al. Low-risk multivariate index assay scores, physician referral and surgical choices in women with adnexal masses. Curr Med Res Opin. 2020;36(12):2079-2083. doi: 10.1080/03007995.2020.1842726. https://pubmed.ncbi.nlm.nih.gov/33107342/   
  • Dunton C, Bullock R, Fritsche H. Ethnic disparity in clinical performance between multivariate index assay and CA125 in detection of ovarian malignancy. Future Oncol. 2019;15(26):3047-3051. doi: 10.2217/fon-2019-0310. https://pubmed.ncbi.nlm.nih.gov/31397588/ 
  • Zhang Z, Bullock R, Fitsche H. Adnexal mass risk assessment: a multivariate index assay for malignancy risk stratification. Future Oncol. 2019;15(33):3783-3795. doi: 10.2217/fon-2019-0479. https://pubmed.ncbi.nlm.nih.gov/31570013/  
  • Eskander R, Carpenter B, Wolf H. The clinical utility of an elevated-risk multivariate index assay score in ovarian cancer patients. Curr Med Res Opin. 2016;32(6):1161-5. doi: 10.1080/03007995.2016.1176014. https://pubmed.ncbi.nlm.nih.gov/27052730/  

Professional Society Support


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