FDA Didn't Approve PreMD's Skin Cholesterol Test

Skin Cholesterol Test

PreMD has received a non-substantially equivalent (NSE) letter from FDA regarding the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. The company expects to evaluate its options as part of the plans to address this issue.

"We are very disappointed with this decision by the FDA regarding our 510(k) submission. We believe we have provided adequate information to support clearance and continue to believe that our product merits clearance by the FDA," said Brent Norton, president and chief executive officer of PreMD.

"The company is pursuing the next steps in addressing the decision and we will work through the process as expeditiously as possible. We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease. Furthermore, 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."

The FDA's primary grounds for rejecting the claim relate to the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint. PreMD submitted the 510(k) application to the FDA in June 2007 based on a study design that was previously accepted as appropriate by the FDA. Subsequently, the FDA requested additional information regarding statistical clarification on the data submitted. The company promptly provided the information requested and believes that it addressed those concerns to the best capabilities of the company. PreMD was not aware of the FDA's issue or concerns from previous discussions.