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Diagnostic Test for Ovarian Cancer Achieves Positive Results
OVA1 is a blood test for presurgical assessment of ovarian tumors for malignancy using a multibiomarker approach. OVA1 is the first protein-based, in vitro diagnostic multivariate index assay approved by the FDA.
The OVA500 study was a prospective, blinded trial involving 494 women who were scheduled to undergo surgery for an adnexal mass. The women were enrolled from nongynecologic oncology practices and represented the intended-use population for the OVA1 diagnostic test. The primary objective of the study was to assess the performance of OVA1 in this patient cohort, with a focus on two challenging subgroups: women with early-stage ovarian cancer (where approximately half of the patients have a normal CA125 level) and premenopausal women (where the incidence of ovarian cancer is low and the incidence of benign cysts is high).
In terms of overall performance, the OVA1 test had a negative predictive value of 98%; sensitivity was 96%; and specificity was 51%.
The test showed 91% sensitivity in women with early ovarian cancer (stage I or II) and 94% sensitivity in premenopausal women.
As a risk-stratification test, the overall sensitivity of OVA1 was 92%.
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