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