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About OVA1 Test for Ovarian Cancer


OVA1®, the first-generation Multivariate Index Assay (MIA) may minimize the uncertainty of the pre-surgical adnexal mass work-up. An FDA-cleared blood test that assesses malignancy risk in adnexal masses planned for surgery.

Using five biomarkers and the patient’s menopausal status, the FDA-cleared OVA1 test may help detect more ovarian cancer than standard testing. This may initiate optimal surgery with a cancer specialist earlier in the care pathway.

Practice Bulletin 174: American Congress of Obstetricians and Gynecologists ACOG Practice Bulletin on “Evaluation and Management of Adnexal Masses”

Read statement here

Level B guidelines state that the physician may use risk assessment tools such as OVA1 (“Multivariate Index Assay”) as listed in the bulletin. The new guidelines suggest that if an elevated risk of malignancy does exist, then the provider must consult with or refer to a gynecologic oncologist.

– American Congress of Obstetricians and Gynecologists

Recent data have suggested that such tests, along with physician clinical assessment, may improve detection rates of malignancies among women with pelvic masses planning surgery.

– Society of Gynecologic Oncology
Society of Gynecologic Oncology Position Statement on “Multiplex Serum Testing for Women with Pelvic Mass”

Read statement here

Validation Study

In the validation study by Bristow et al.,1 OVA1 with clinical assessment demonstrated:

Sensitivity: 96%

Negative Predictive Value: 98%