September 14, 2009
FDA approves ovarian cancer test
The U.S. Food and Drug Administration says it's approved 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 healthcare professionals decide what type of surgery should be done and by whom, the agency said.
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,the FDA said in a statement.
If other test results suggest cancer, referral to an oncologist is appropriate even with a negative Ova1 result.
The federal agency said 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 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass, the FDA said.
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.
Ova1 was developed by Vermillion Inc. of Fremont, Calif., in conjunction with researchers at Johns Hopkins University in Baltimore.