FDA Puts Brakes on Expanded Indication for PreMD’s Skin Sterol Diagnostic

Company to decrease spending to ensure its ability to execute.

Tortono, Ontario-based PreMD received a non-substantially equivalent letter from the FDA regarding its 510(k) submission for an expanded regulatory claim on its skin cholesterol test.

The company’s PREVU Skin Cholesterol Test non-invasively measures skin tissue cholesterol. Skin cholesterol is believed to be a risk factor for heart disease and can be used an as adjunct to CAD risk assessment.

The company submitted its 510(k) this June seeking to obtain broader clearance for the assessment of cardiovascular disease risk in individuals without known or suspected disease.

The expanded claim would dramatically increase the market potential of PREVU.

Skin contains over 11% of the body’s cholesterol and ages in parallel with vascular connective tissue. As blood vessel walls accumulate cholesterol, so do the skin tissues. A high skin cholesterol level is a reliable predictor of higher cholesterol accumulation in the arteries and, accordingly, risk of heart disease.

The company’s skin sterol test is believed to have a significant association with increased carotid intima-media thickness (CIMT), an independent predictor of myocardial infarction and stroke. Said Dr. James Stein, a principal investigator in the study on which the submission was based, “There is considerable interest in non-invasive, simple and rapidly administered tests to better assess which patients are at increased risk. The significant association with increased CIMT suggests that skin sterol testing may help to identify asymptomatic patients who are at future risk of having a heart attack or stroke.”

The FDA’s primary grounds for rejecting the 510(k) related to the clinical utility of evaluating skin cholesterol with CIMT as the clinical endpoint. Prior to its decision, the FDA had requested information regarding the statistical clarification on the data submitted. The company provided the information requested and believed that it addressed concerns to the best of its abilities.

Commenting on the FDA’s decision, Brent Norton, President and CEO of PreMD said,

“We believe we have provided adequate information to support clearance and continue to believe that our product merits clearance by the FDA. The company is pursuing the next steps in addressing the decision and we will work through the process as expeditiously as possible.”

“Our recent clinical achievements such as our presentation at the American Heart Association and scheduled publication in the American Journal of Cardiology for April show that we are supported in our belief of the strength of our product. The company has adequate cash to support operations through the near term. However, we will continue to evaluate and decrease spending throughout the organization to ensure our ability to execute the necessary tasks.”

A 600-person trial is now underway to further examine the relationship between skin sterol and CIMT. According to PreMD management, the study is expected to generate the data needed to expand PREVU’s indications.

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