According to the New York Times, the U.S. Food and Drug Administration is raising the alarm about a new blood test called OvaSure that is claimed to detect early-stage ovarian cancer.

In an Aug. 7 letter to LabCorp, the test distrinutor and one of the largest U.S. clinical laboratory firms, the FDA said, “We believe you are offering a high-risk test that has not received adequate clinical validation and may harm the public health.” the Times reported.

The test has been on the market for about two months. 

The FDA usually has made it clear to LabCorp that the agency is not satisfied that testing has been inadequate to clearly demonstrate that the OvaSure test actually works.

The Society for Gynecologic Oncologists has issued a statement questioning the test.

Source
New York Times