OVA1 vs CA 125II

OVA1 is a blood test that has been FDA-cleared for the pre-surgical evaluation of a woman with an ovarian mass, whereas CA 125II is cleared for use as an aid in monitoring patients previously treated for ovarian cancer. CA 125II is one of the five biomarkers included in the OVA1 score.

OVA1 Shows Superior Sensitivity Over CA 125II2

Data from the OVA1 clinical trial provides a performance comparison of OVA1 to CA 125II. Although neither OVA1 nor CA 125II 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 CA 125II level, ascites, a nodular or fixed pelvic mass, or evidence of abdominal or distant metastasis
  • Premenopausal: Very elevated CA 125II 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 CA 125II 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%
CA 125II (67 U/mL) 77.0% 87.7%
CA 125II (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), CA 125II and referral guidelines, OVA1 significantly improved clinical sensitivity while increased NPV strengthened the predication that cancer was absent.