What is OVA1 blood test?
OVA1 is an FDA-cleared blood test with an unparalleled ability to detect ovarian cancer risk in women who are planned for surgery for a pelvic mass.
How accurate is OVA1 test?
A low-risk OVA1 test result correctly predicted the absence of malignancy by 98 percent. The authors concluded that the OVA1 test is a useful blood test to check prior to surgery performed by general gynecologist.
How much does an OVA1 test cost?
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.
What is a Roma blood test?
ROMA is a qualitative serum test that derives a numerical score from the results of CA-125 (the most widely accepted biomarker for ovarian cancer) and HE4 blood tests, plus menopausal status, to identify patients presenting with an adnexal mass as being at high or low likelihood for having malignancy.
What is HE4 tumor marker?
Human epididymis protein 4 (HE4) is a protein that is produced by most, but not all, epithelial ovarian cancer cells. This makes the test useful as a tumor marker in specific circumstances. The HE4 test measures the amount of human epididymis protein 4 in the blood.
How is ova 1 test done?
OVA1 uses a blood sample to test for levels of five proteins that change because of ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.
Where is the adnexal mass located?
An adnexal mass is a growth that occurs in or near the uterus, ovaries, fallopian tubes, and the connecting tissues. They’re usually benign, but are sometimes cancerous. Some of them are filled with fluid, and some are solid.
What is normal HE4 range?
HE4 reference ranges for each group and association of HE4 levels with BMI, creatinine, and smoking were investigated. Results. HE4 reference limit for healthy patients equals 85 pmol/l, which becomes 73 pmol/l and 93 pmol/l for pre and postmenopausal subgroups, respectively.
How accurate is HE4?
The combination of HE4 and CA125 showed sensitivity 75.8%, specificity 93.5%, and accuracy 85.7%.
How is OVA1 used to diagnose ovarian cancer?
OVA1, a first-generation Multivariate Index Assay (MIA), evaluates the levels of five ovarian cancer-associated markers in the blood and utilizes a sophisticated mathematical formula to combine these levels into a single ovarian cancer risk score.
What to do with a negative OVA1 test?
“The OVA1 test identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiological tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result,” the FDA states.
Is the OVA1 blood test approved by the FDA?
The FDA cleared the OVA1 test based on a study of 516 patients, including 269 patients evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results.
What happens if you get a low OVA1 score?
This would mean a referral to an oncologist would be more likely to happen. Lower scores have a lower probability of cancer, which means if a surgery is necessary, it can often be done without the help of a specialist. Not every health insurance provider currently covers the OVA1 blood test.