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PreMD Provides Update on FDA Review
Date:4/11/2008

TORONTO, April 11 /PRNewswire-FirstCall/ - Predictive medicine company PreMD Inc. (TSX: PMD; Amex: PME) today announced that the U.S. Food and Drug Administration ("FDA") has upheld their decision regarding the company's appeal of the not substantially equivalent (NSE) letter it received in January 2008 in connection with a premarket submission to expand indication for its skin cholesterol test. In the ruling, the FDA agreed with the company on two of the three issues on appeal, but concluded that the clinical trial data was not sufficient to determine that the product is substantially equivalent to other markers of cardiovascular risk. PreMD submitted the 510(k) notification in 2007 with the data from a clinical study that was based on guidance received from the FDA in 2004.

"Our situation now is strictly in the area of a scientific disagreement. There is a well defined process for a scientific dispute resolution, one of the paths we will be exploring immediately," said Brent Norton, president and CEO of PreMD. "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. 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."

The Company disagreed with the original decision as expressed in the NSE determination letter and, in response, appealed the decision via a review with FDA officials. A written appeal was submitted to the FDA and a meeting was held on March 21, 2008 between PreMD, several medical experts, regulatory consultants, executives from AstraZeneca Pharmaceuticals LP, and various FDA personnel involved in the review process. PreMD presented expert analysis of the data gathered during clinical trials, in particular that data relating to the use of carotid intima wall thickness (CIMT) is a determinant for those a
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SOURCE PreMD Inc.
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