A NEW BLOOD TEST FOR OVARIAN CANCER

September 14, 2009 — The US Food and Drug Administration (FDA) has approved a novel blood test (OVA1, Vermillion Inc and Quest Diagnostics) to help detect ovarian cancer in adult women with pelvic tumors that are known to need surgery.

The test consolidates immunoassay results for 5 proteins known to change with ovarian cancer, rating the likelihood of malignancy on a scale of 1 to 10.

"OVA1 is the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity prior to biopsy or exploratory surgery, even if radiological test results fail to indicate malignancy," the company said in a news release.

Identifying potentially malignant cases before surgery allows involvement of a gynecologic oncologist, which can improve patient outcome.

The OVA1 Test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The test utilizes five well-established biomarkers --- Transthyretin (TT or prealbumin), Apolipoprotein A-1 (Apo A-1), Beta2-Microglobulin (Beta2M), Transferrin (Tfr) and Cancer Antigen 125 (CA 125 II) --- and a proprietary algorithm to determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned.

According to the FDA, ovarian cancer patients have demonstrated improved survival when the surgery is performed by gynecologic oncologists rather than general gynecologists or surgeons.

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

OVA1 should only be used to compliment other diagnostic and clinical procedures; the test is not indicated for screening purposes or to achieve a definite diagnosis of ovarian cancer.