Early Detection Research Network


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.
Clinical tests of OVA1 versus CA125 alone showed that OVA1 correctly predicted 94% of malignancies in a sample of 516 patients, versus 77% for CA125. OVA1 also increased accurate prediction in premenopausal women to 91%, versus fewer than 58% with CA125. OVA1 does have a two times greater chance than CA125 of predicting a malignancy where there is none (false positive). However, the patients using the OVA1 test are all scheduled for surgery to remove an ovarian mass, and the slightly higher false positive rate simply raises the probability that a gynecologic oncologist will perform the surgery.

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