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FDA clears test for ovarian cancer

The FDA has approved a test that can help detect ovarian cancer in a pelvic mass already known to require surgery

The US Food and Drug Administration (FDA) has approved a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. Named OVA1, the test helps patients and healthcare professionals decide what type of surgery should be done and by whom.

OVA1 identifies some women who will benefit from referral to a gynaecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. Conversely, if there is a negative OVA1 result but other test results suggest cancer, patients would still be referred to an oncologist.

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

The test 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.

14th September 2009

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