OVA1®

Intended Use

Ova1^® is a qualitative serum test that combines the results of five immunoassays into a single numerical result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. Ova1^® 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. The test is not intended as a screening or stand-alone diagnostic assay.

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 the Ova1^® carries the risk of unnecessary testing, surgery, and/or delayed diagnosis.

Ova1^® Qualified Reagents

Qualified reagent lots can be accessed by clicking the link below. See the Ova1^® Instructions for Use (LBL001) for assay instructions.

Ova1^® Qualified Reagents

Ova1^® Software Download

Click the link below to access the OvaCalc^® Software Download Center. See the Ova1^® Instructions for Use (LBL001) for software download and installation instructions. Only Vermillion authorized users are allowed to download the OvaCalc^® Software.

OvaCalc Software

Ova1^® Instructions for Use

Click the link below to access the Ova1^® Instructions for Use by language.

Ova1^® Instructions for Use

FDA IVD

Ova1^® Home

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