FDA Approves Vermillion’s Ovarian Cancer Test

ovariancancerThe U.S. Food and Drug Administration has approved a blood test to detect ovarian cancer and help physicians decide what kind of surgery should be done and by whom. OVA1, developed by Vermillion in conjunction with Johns Hopkins University, is intended for women who have a pelvic mass requiring surgery.

OVA1 may identify some women who would benefit from referral to a gynecological oncologist for their surgery, despite  negative results from other tests for ovarian cancer. The American College of Obstetricians and Gynecologists has previously found that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

The test checks the levels of five proteins that change due to breast cancer, then uses an algorithm to assign the patient a score between 0 and 10.  The score indicates the likelihood of the tumor being benign or malignant. OVA1 is intended to complement, not replace, other diagnostic and clinical procedures.

Upon the announcement, stock in Vermillion skyrocketed by 2,587 percent.  Vermillion announced that their partner, medical testing company Quest Diagnostics, would make OVA1 available in the fourth quarter.

September is Ovarian Cancer Awareness Month. Ovarian cancer is among the top ten most common cancers for women. Companies developing tests to diagnose ovarian cancer include Stage 1 DiagnosticsSeno Medical Instruments, RCP Diagnostics, and CytoCore.

1 reply »

  1. This is very good news…..I realize the test will probably not be used to screen the general population, but will it be available for women considered high risk although they have not been diagnosed to have a tumor? Is this test similar to Ovasure which is currently in trial with Lab Corp?

    Thank you
    Marilyn Gallagher
    Green Bay, WI

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