Cholestech seeks test reclassification under CLIA
This article was originally published in Clinica
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.
You may also be interested in...
A regulatory framework that encourages physicians to conduct experimental cell and gene therapies have propelled China to become a major developer of such promising cancer-treating tools, but insiders say three are a plethora issues at stake.
The first of around 260 patients for a clinical trial comparing its PB006 natalizumab biosimilar candidate to Biogen’s Tysabri reference brand have been recruited by Polpharma Biologics, which has just added Karsten Roth and Alexandra Moulson to its team.