Cholestech seeks test reclassification under CLIA
This article was originally published in Clinica
Executive Summary
Now that the US CDC has resumed reviewing requests for waiver of specific CLIA requirements for laboratory testing devices, Cholestech has filed a petition seeking reclassification of its LDX System. The CDC lifted the moratorium on classifying testing devices as waived tests in December. Cholestech believes its total cholesterol, HDL cholesterol, triglycerides and glucose tests meet criteria to reclassify them from moderately complex to waived under CLIA '88.