Ova 1
OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical result. The tests include:
- CA125 (increased in ovarian tumors)
- Apolipoprotein A1 (decreased in ovarian tumors)
- Beta-2 microglobulin (increased in ovarian tumors)
- Transferrin (decreased in ovarian tumors)
- Pre-albumin (decreased in ovarian tumors)
The tests are performed by Quest Diagnosics under an exclusive license agreement with Vermillion. CA125 is performed on the Roche Elecsys and the four other analytes are performed on the Siemens BNII. Quest submits the results of each analyte to Vermillion who uses proprietary software, called OvaCalc, to calculate an OVA 1 score, which ranges from 0 to10. A high probability of malignancy is defined as a score of 5.0 or greater in premenopausal women and 4.4 or greater in postmenopausal women.Only the OVA 1 score is reported to the ordering physician; not the results of the five component tests. The test costs about $650.
The OVA1 Test is an aid to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. It can be used by a patient’s primary physician to decide if the patient should be referred to a gynecologist or a gynecologic oncologist.
The FDA has approved the use of OVA1 for women who meet the following criteria:
- Over 18 years of age
- Has an ovarian adnexal mass
- Have surgery planned
- Has not yet been referred to a gynecologic oncologist; and
- Has not had cancer in the past five years
OVA1 test should not be ordered if clinical assessment or risk of malignancy warrants referral to a gynecological oncologist, since it does not provide additional information.
OVA1 score may be elevated in primary epithelial ovarian malignancies. Benign epithelial tumors, stromal tumors, germ cell tumors, or metastatic tumors may not be associated with an elevated score.
OVA1 is not intended to be a screening test for ovarian cancer and should not be ordered with CA125. It should not be used to determine whether a patient should proceed to surgery.
