OVA1 vs CA125

OVA1 is a blood test that has been FDA-cleared for the pre-surgical evaluation of a woman with an ovarian mass, whereas CA125 is cleared for use as an aid in monitoring patients previously treated for ovarian cancer. CA125 is one of the five biomarkers included in the OVA1 score.

OVA1 Shows Superior Sensitivity Over CA125-II2

Data from the OVA1 clinical trial provides a performance comparison of OVA1 to CA125-II. Although neither OVA1 nor CA125 are cleared to be used as stand-alone diagnostic tests, removing the variable of physician assessment and basing an evaluation on individual performance is the only manner in which they can be directly compared.

In a head-to-head study OVA1 showed superior sensitivity over CA125-II

Current ACOG/SGO Referral Guidelines

  • Postmenopausal: Elevated CA125 level, ascites, a nodular or fixed pelvic mass, or evidence of abdominal or distant metastasis
  • Premenopausal: Very elevated CA125 level, ascites, a nodular or fixed pelvic mass, or evidence of abdominal or distant metastasis

OVA1 vs. Available Tools 1,2

As part of the OVA1 clinical trial, the physician's evaluation included a combination of pelvic exam, transvaginal ultrasound/imaging, a CA125 test results and/or CT scan. The recommended ACOG/SGO guidelines (above) were also used by many physicians. The data for sensitivity and negative predictive value for each approach are noted in the table below.

Sensitivity NPV
Clinical Impression (CI) 75.1% 87.5%
CA125-II (67 U/mL) 77.0% 87.7%
CA125-II (200 U/mL) 68.9% 85.8%
ACOG/SGO guidelines 77.0% 87.0%
Dual Impression (OVA1+CI) 95.7% 94.7%

When compared to the physician's Clinical Impression (CI), CA125-II and referral guidelines, OVA1 significantly improved clinical sensitivity while increased NPV strengthened the predication that cancer was absent.