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PreMD disputes FDA ruling

The US Food and Drug Administration has upheld its original decision not to approve a skin cholesterol test, denying an appeal from PreMD Incorporated
The US Food and Drug Administration (FDA) has upheld its original decision not to approve a skin cholesterol test, denying an appeal from PreMD Incorporated.

PreMD, a developer and manufacturer of predictive medicine products, appealed the FDA's original decision to deny a premarket submission to expand indication for its cholesterol skin screening. The appeal was launched after the FDA issued PreMD with a not substantially equivalent (NSE) letter in January 2008.

Brent Norton, president and CEO of PreMD, said: "While the agency has agreed with two of the three issues, including the use of CIMT as a clinical endpoint, we are very disappointed with the decision."

"Our situation is now strictly in the area of a scientific disagreement," he added.

The FDA said that there was insufficient data from clinical trials to determine whether PreMD's skin cholesterol test was as efficacious as other cardiovascular risk markers.

Norton said: "We continue to believe that our skin cholesterol test is a beneficial product for healthcare providers and patients, as the test adds to our understanding of those at cardiovascular risk."

11th April 2008

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