Blood test for ovarian cancer OVA1 from Vermillion approved in US

OVA1 blood test can predict chances of cancer in the ovaries before biopsy

A laboratory screening test to detect ovarian cancer OVA1, before surgery or biopsy developed by Vermillion Inc has won approval from US FDA.

Named OVA1, the test can indicate the likelihood of ovarian cancer, even if radiological tests fail to indicate malignancy.

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 test can help patients and health care professionals decide what type of surgery should be done and by whom, a vermillion press release said.

OVA1 screening test 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 chance that the pelvic mass is benign or malignant.

OVA1 test is a qualitative serum test that combines the results of five immunoassays into a single numerical score. 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.

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.

OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal, the release stated.

OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

“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,” said Jeffrey Shuren, MD, JD, acting director of the FDA’s Center for Devices and Radiological Health.

Vermillion submitted clinical data of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results to US FDA for review.

When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

OVA1 test will be available for physician use in the fourth quarter of this year.

What is ovarian cancer?
Ovarian cancer is the deadliest of all the cancers of the female reproductive system and a leading cause of cancer death among women. 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.

Symptoms of ovarian cancer 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.

Vermillion, Inc is into development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Based in Fremont, California, Vermillion, along with its scientific collaborators, has diagnostic programs in oncology, hematology, cardiology and women’s health.

Quest Diagnostics is the world’s leading provider of diagnostic testing, information and services. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care.