Monday, PreMD Inc. (PMD.TO,PME) said that the U.S. Food and Drug Administration, or FDA, has upheld their decision regarding the company's not substantially equivalent, or NSE, letter it received this January in connection with its pre-market submission to expand the indication for use of its FDA cleared skin cholesterol test.
PreMD said its skin cholesterol test non-invasively measures the amount of cholesterol that has accumulated in the skin tissues, as opposed to blood. The test takes 3 minutes to complete and there is no fasting or other patient preparation required. Clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin.
The Toronto, Ontario-based predictive medicine company said that in the ruling, the FDA maintained that there are fundamental defects in both the study design and data analysis. PreMD said it will work with its advisors and partners to examine its options.
Throughout 2004 and 2005 PreMD sought and received guidance from the FDA regarding the clinical trial design and data required for an expanded indication for use of the PREVU Point-of-Care skin cholesterol test.
PreMD executed the US multi-site clinical trial entitled -"Increased Skin Cholesterol Identifies Individuals at Increased Cardiovascular Risk: The Predictor of Advanced Subclinical Atherosclerosis (PASA) Study."
The trial was led by Cardiologist, Dr. James Stein of the University of Wisconsin, and was completed in early 2007. The results were presented in the American Heart Association Scientific Sessions in 2007 and a paper based on the data was published in the American Journal of Cardiology in April 2008. The technology, which is both cleared for sale in Canada and CE marked, was also licensed by AstraZeneca Pharmaceuticals LP in July 2007 for potential marketing and distribution in the United States, the company said.
PME is presently down $0.20 or 68.88% and trades at $0.09. PMD.TO is currently down C$0.18 or 64.29% and trades at C$0.10.
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