The OVA1 diagnostic test is comprised of five biomarkers: CA125, transthyretin (prealbumin), apolipprotein A1 (Apo A-1), beta-2 microglobulin, and transferrin. OVA1 is an In Vitro Diagnostic Multivariate Index Assay (IVDMIA) of Proteomic Biomarkers test that analyzes the serum levels of these five proteomic biomarkers. OVA1 is the first FDA approved test for assessing ovarian cancer risk in women previously diagnosed with an ovarian mass, and already scheduled for surgery. The OVA1 algorithm combines the results of these levels with information on the menopause status of the patient to classify the patient into a low- or high-risk group. The results of the OVA1 test can help determine patients needing referral to a gynecologic oncologist for their surgery.
There are no datasets associated with this biomarker.
The following organs have data associated with this biomarker…
OVA1 is intended for women 18 years old and older who have a previously identified ovarian mass. It is not intended to be used as a widespread screening tool or for diagnostic purposes. The OVA1 test is used in conjunction with other clinical and radiographic data to determine referral to a gynecologic oncologist.
- A recipe for proteomics diagnostic test development: the OVA1 test, from biomarker discovery to FDA clearance.
- The road from discovery to clinical diagnostics: lessons learned from the first FDA-cleared in vitro diagnostic multivariate index assay of proteomic biomarkers.
- Differential diagnosis of a pelvic mass: improved algorithms and novel biomarkers.