ChemTrak AccuMeter cholesterol test receives CLIA "waived" status.
This article was originally published in The Gray Sheet
Executive Summary
CHEMTRAK ACCUMETER CHOLESTEROL TEST MOVED TO CLIA "WAIVED" CATEGORY, the Sunnyvale, California-based company announced March 20. The reclassification decision by the Centers for Disease Control and Prevention clears the way for ChemTrak to market the diagnostic test to "more than 45,000 sites in physician offices, clinics and wellness programs...registered to perform waived testing only" under the Clinical Laboratory Improvement Amendments of 1988, the company said.