A Medical Device Daily

The FDA has cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom. OVA1 is made by Vermillion (Fremont, California), in conjunction with researchers at The Johns Hopkins University (Baltimore).

OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

The test should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures. OVA1 uses a blood sample to test for levels of five proteins that change due to 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.

"Tests such as OVA1 personalize and improve public health by providing patients and healthcare providers with more information to support medical decisions that impact survival rates and reduce surgical complications," said Jeffrey Shuren, MD, acting director of the FDA's Center for Devices and Radiological Health.