New ovarian cancer test approved

Article

On Sept. 11, the Food and Drug Administration cleared OVA1, a test that helps detect ovarian cancer in women with pelvic masses requiring surgery.

On Sept. 11, the Food and Drug Administration cleared OVA1, a test that helps detect ovarian cancer in women with pelvic masses requiring surgery. OVA1 was developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at Johns Hopkins University in Baltimore.

The FDA reviewed a study of 516 women, including 269 patients who were evaluated by non-gynecologic oncologists, comparing OVA1 results with biopsy results. It was determined that, even if other radiographic and clinical tests have negative results, OVA1 could help identify women who might benefit from referral to a gynecologic oncologist for surgery. OVA1 uses a blood sample to test for levels of five proteins that change because of ovarian cancer.

In the news release, the FDA emphasized that the test is only for women aged 18 years and older who have already been selected for surgery because of pelvic masses, and it should complement-not replace-other tests. According to the agency, if other test results suggest cancer, it is appropriate to refer a patient to an oncologist even if OVA1 results are negative.

For more details on the FDA decision, see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182057.htm.

Recent Videos
Eran Bornstein, MD, highlights early signs of preeclampsia clinicians need to know | Image Credit: northwell.edu.
Eran Bornstein, MD explains the need for first trimester preeclampsia screening | Image Credit: northwell.edu.
Veerle Bergink, MD, PhD, highlights familial links of postpartum psychosis | Image Credit: profiles.mountsinai.org.
Ivie Odiase, MD
Susan Khalil, MD
Sharon Erdrich, PhD, discusses why oral health should be routine in health care | Image Credit: linkedIn.com.
Sharon Erdrich, PhD, highlights oral health's impact on chronic pain | Image Credit: linkedIn.com.
Fiona Gilbert, MA, MB, discusses breast cancer screening for dense breasts | Image Credit: newn.cam.ac.uk
Related Content
© 2025 MJH Life Sciences

All rights reserved.