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 (Nov. 20, 2014)
Click here for the OVA1 Instructions For Use (IFU).
Click here for the OvaCalc software.
- Carney ME, et al., Gynecol Oncol. 2002 Jan;84(1):36-42.
- Earle CC, et al., J Natl Cancer Inst. 2006 Feb 1;98(3):172-80
- Ueland, FR et al., Gynecol Oncol. 2005 Nov;99(2):400-3
- Goodrich ST, et al., Am J Obstet Gynecol. 2014 Jul;211(1):65.e1-65.e11
- Bristow RE, et al., Gynecol Oncol. 2013;128:252-259
- Timmerman D, et al., Ultrasound Obstet Gynecol 1999;13:11–16
- Levine D, et al., Ultrasound Q. 2010 Sep;26(3):121-31.
- Ueland FR, et al., Obstet Gynecol. 2011;117(6):1289-1297
- Longoria TC, et al., Am J Obstet Gynecol. 2014 Jan;210(1):78.e1-9
- Moss EL, et al., J Clin Pathol. 2005 Mar; 58(3): 308–312.
- Petignat P, et al., Eur J Cancer. 2000 Oct;36(15):1933-7.
- Bristow RE, et al., Am J Obstet Gynecol. 2013 Dec;209(6):581.e1-8