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.

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.


  1. Carney ME, et al., Gynecol Oncol. 2002 Jan;84(1):36-42.
  2. Earle CC, et al., J Natl Cancer Inst. 2006 Feb 1;98(3):172-80
  3. Ueland, FR et al., Gynecol Oncol. 2005 Nov;99(2):400-3
  4. Goodrich ST, et al., Am J Obstet Gynecol. 2014 Jul;211(1):65.e1-65.e11
  5. Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
  6. Timmerman D, et al., Ultrasound Obstet Gynecol 1999;13:11–16
  7. Levine D, et al., Ultrasound Q. 2010 Sep;26(3):121-31.
  8. Ueland FR, et al., Obstet Gynecol. 2011;117(6):1289-1297
  9. Longoria TC, et al., Am J Obstet Gynecol. 2014 Jan;210(1):78.e1-9
  10. Moss EL, et al., J Clin Pathol. 2005 Mar; 58(3): 308–312.
  11. Petignat P, et al., Eur J Cancer. 2000 Oct;36(15):1933-7.
  12. Bristow RE, et al., Am J Obstet Gynecol. 2013 Dec;209(6):581.e1-8

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