The PreMD’s appeal over the NSE (not substantially equivalent) letter it received for a premarket submission to expand indications for its skin cholesterol test has been upheld by the FDA.  The FDA agreed that the clinical trial data was not sufficient to say if the product was substantially equivalent to other markers of cardiovascular risk.

The FDA has sent an NSE (non-substantially equivalent) letter to PreMD Inc. related to the 510(k) submission for an expanded regulatory claim on its point-of-care (POC) skin cholesterol test. “We continue to believe that this test fulfills a need for screening asymptomatic patients for risk of cardiovascular disease,” the company said. The FDA has rejected the claim citing concerns over the clinical utility of evaluating skin cholesterol with carotid wall intima thickness (CIMT) as the clinical endpoint.