FDA PANEL MEETS TO DISCUSS LIPID DIAGNOSTIC ASSAY

The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel met Dec. 6 to hear recommendations regarding the validity of lipid subfraction diagnostic assays to show patients' risk of cardiovascular disease (CVD).

Certain subclasses of known lipid risk factors may be new candidate biomarkers to detect CVD, which is the leading cause of death in the U.S. Discovery of new biomarkers to detect CVD is a national priority, according to the FDA.

A variety of technologies have been developed to separate and measure lipid subfractions, said a panel meeting briefing. However, "it is unclear to FDA whether meaningful and reproducible diagnostic cutoffs can be established," the briefing added. Measurements of lipid subfractions "may not be predictably different between 'at risk' and normal populations. This raises concerns regarding whether these candidate biomarkers can be used safely and effectively to, for example, predict CVD risk."