First Blood Test for Ovarian Cancer Wins FDA Approval

On Friday, September 11, the FDA announced their approval of the first laboratory test that, prior to exploratory surgery or biopsy, can indicate the likelihood of ovarian cancer, even if radiological tests fail to indicate malignancy. The announcement comes at a fitting time—during September—the month recently designated by President Obama as National Ovarian Cancer Awareness Month.

The test, called OVA1, was developed by California-based Vermillion Inc., in conjunction with their partner, Quest Diagnostics, and with researchers at The Johns Hopkins University in Baltimore. OVA1 uses a blood sample to check levels of five proteins that change due to ovarian cancer, and then simplifies the results into a score between zero and 10, indicating whether the pelvic mass is benign or malignant. The test is intended only for women 18 and older who are already selected for surgery because of their pelvic mass. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

The FDA’s approval of OVA1 was based on a study comparing its results with biopsy results for 516 patients, including 269 patients evaluated by non-gynecological oncologists. Results from the OVA1 tests, when combined with pre-surgical information, such as radiography and other laboratory tests, identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone. The agency stresses, however, that the OVA1 test is not intended for a definitive diagnosis of ovarian cancer and should be used to compliment, not replace, other diagnostic and clinical procedures.

Reports have shown that patients with malignant ovarian cancer have more favorable outcomes when their surgery is performed by a gynecologic oncologist, a doctor trained in treating cancers of a woman’s reproductive system, as opposed to a general gynecologist or surgeon. But deciding who would perform the surgery has been difficult at best since it was usually only after surgery that the sensitivity of a mass was determined. “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,” Dr. Jeffrey Shuren, acting director of the FDA’s Center for Devices and Radiological Health, said in a press release.

Ovarian cancer remains the deadliest of all the cancers of the female reproductive system and a leading cause of cancer death among women. Called a “silent killer,” many of its symptoms often mimic other, less life threatening diseases, so an early diagnosis may be overlooked. In fact, fewer than 20 percent of ovarian cancer cases are diagnosed in the early stages, when survival rates are highest. Each year in the U.S. an estimated 21,550 new cases of ovarian cancer are diagnosed and nearly 15,000 women die from the disease.

By helping women to recognize the symptoms of ovarian cancer, and monitor their persistency, women can become stronger advocates for their own health. Symptoms include: bloating, pelvic or abdominal pain, difficulty eating or feeling full quickly, and urinary urgency or frequency. There is no definitive test for ovarian cancer, so experts suggest a combination of physical exam, including pelvic and rectal, a CA-125 blood test and a transvaginal ultrasound.