NEW YORK (GenomeWeb) – Companion diagnostics firm ImmunID announced today that it has received Clinical Laboratory Improvement Amendments (CLIA) certification for its laboratory in Grenoble, France from the US Department of Health and Human Services.
With the certification, ImmunID's lab can now receive patient specimens from the US for testing with its ImmuneTracker Dx assay, a PCR-based system that detects gene recombinations in T cells to provide data about how a cancer patient's immune system is responding to a particular immunotherapy.
"This is a critical regulatory and commercial milestone for ImmunID," ImmunID Chairman and CEO Bernhard Sixt said in a statement. "We are proud to be the first French company to receive this lab certification … and are very excited to start providing American doctors with a medical routine assay to evaluate their patients' immune status."