Ovarian cancer test
This article was originally published in The Gray Sheet
Executive Summary
FDA cleared Vermillion Inc.'s OVA1 test Sept. 11 to help detect ovarian cancer in pelvic masses known to require surgery, allowing clinicians to determine the type of surgery needed. OVA1 is used as an adjunct to other procedures to determine if a pelvic tumor is malignant prior to biopsy or exploratory surgery, even when radiological tests fail to indicate malignancy, FDA and the firm say. OVA1 tests patient blood for levels of five proteins affected by ovarian cancer, and then combines the results into a numerical score between zero and 10 indicating whether the mass is benign or malignant. OVA1 is not intended for ovarian cancer screening or definitive diagnosis of cancer, FDA notes. Quest diagnostics has exclusive rights to market the test in the U.S. for three years. FDA pressured Quest-competitor LabCorp to stop marketing a similar "in vitro diagnostic multivariate assay"-style ovarian cancer test last October for not having the appropriate FDA clearance (1"The Gray Sheet" Oct. 27, 2008)