September
14, 2009 - The U.S. Food and Drug Administration (FDA) has approved a
novel blood test (OVA1, Vermillion Inc and Quest Diagnostics) to help
detect ovarian cancer in adult women with pelvic tumors that are known
to need surgery.
The test
consolidates immunoassay results for 5 proteins known to change with
ovarian cancer, rating the likelihood of malignancy on a scale of 1 to
10.
"Ova1 is the first
FDA-cleared laboratory test that can indicate the likelihood of ovarian
cancer with high sensitivity prior to biopsy or exploratory surgery,
even if radiological test results fail to indicate malignancy," the
company said in a news release.
Identfying
potenially malignant cases before surgery allows involvement of a
gynecologic oncologist, which can improve patient outcome.
According
to the FDA, ovarian cancer patients have demonstrated improved survival
when the surgery is performed by gynecological oncologists rather than
general gynecologists or surgeons.
"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," noted Jeffrey Shuren, MD, JD, acting director of the
FDA's Center for Devices and Radiological Health.
OVA1
should only be used to cosmpliment other diagnostic and clinical
procedures; the test is not indicated for screening purposes or to
achieve a definite diagnosis of ovarian cancer. |
