Ovarian Cancer Tests and Diagnostics
Ovarian Cancer Test Approved
Helps doctors decide on appropriate surgical options
FRIDAY, Sept. 11 (HealthDay News) -- The U.S. Food and Drug Administration has approved a new test for women with pelvic tumors that are known to need surgery. The test, called OVA1, will help doctors decide if the tumor probably is ovarian cancer and how to proceed surgically.
OVA1 will identify some women who have negative results from ovarian cancer tests, but whose surgical cases would benefit from a gynecological oncologist's involvement, the agency said in a news release. Gynecological oncologists -- doctors who specialize in women's cancer -- have been found to help improve survival when they perform ovarian cancer surgery, the FDA said.
The new blood test -- approved for women aged 18 and older who have pelvic masses that require surgery -- is not meant to screen for ovarian cancer or replace diagnostics used to detect ovarian cancer, the FDA stressed.
OVA1 is produced by California-based Vermillion Inc., in conjunction with scientists at The Johns Hopkins University in Baltimore.
The FDA has more about this approval.