This is a recent article about LabCorp and their practices. The United States Food and Drug Administration believes that LabCorp’s testing “…may harm the public health.” Shame on you LabCorp for putting money before patient’s health.

The US Food and Drug Administration is looking more closely at an ovarian cancer test from Laboratory Corporation of America after deciding that the existing data did not support the test’s commercial use.

 

The FDA Office of In Vitro Device Evaluation and Safety has asked Labcorp to discuss with the agency the utility of its OvaSure Yale test, after it learned that the performance characteristics of the test were based on research that is not representative of the intended pool of patients.

 

In a letter to Labcorp dated August 7, OIVD Director Steve Gutman wrote that the scientific community would not view the study as sufficient to establish performance characteristics for high-risk women who may have ovarian cancer.

 

“Based on our review of your promotional materials and the research,” Gutman wrote, “… we believe you are offering a high risk test that has not received adequate clinical validation, and may harm the public health.” Gutman told Labcorp that OIVD would like to talk to the company about offering the test, and any other strategies the company may have for validating the test.

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