OVA1 Testing

OVA1 minimizes the uncertainty of the pre-surgical adnexal mass work-up

Using five biomarkers and the patient’s menopausal status, the FDA-cleared OVA1 test helps detect more ovarian cancer than standard testing. This can initiate optimal surgery with a cancer specialist earlier in the care pathway. And with 96% of cancers stratified, you can confidently manage adnexal masses determined as low risk.


OVA1 has been FDA cleared for women who meet the following criteria:

  • Are over 18 years of age
  • Have an ovarian mass
  • Have surgery planned
  • Have not yet been referred to a gynecologic oncologist
  • Have not had cancer in the past five years; and
  • Have a rheumatoid factor concentration <250 IU/mL

PRECAUTION: OVA1 should not be used without an independent clinical/radiological evaluation and is not intended to be a screening test or to determine whether a patient should proceed to surgery. Incorrect use of OVA1 carries the risk of unnecessary surgery and/or delayed diagnosis.

Clinical Validation Study5,8

In the pivotal study by Bristow, et al., OVA1 with clinical assessment5:

  • Identified 83% of cancers missed by clinical assessment
  • Identified 71% of cancers missed by CA-125II
  • Demonstrated negative predictive value of up to 98%

SGO position statement

Multiplex Serum Testing for Women with Pelvic Mass

Link: https://www.sgo.org/newsroom/position-statements-2/multiplex-serum-testing-for-women-with-pelvic-mass/

Click here for the OVA1 Instructions For Use (IFU).

Click here for the OvaCalc software.


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  5. Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
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  12. Bristow RE, et al., Am J Obstet Gynecol. 2013 Dec;209(6):581.e1-8