CLIA Certificate Granted for Laboratory in France

By Kelly A. Briganti, Editorial Director, G2 Intelligence

As recently reported in Laboratory Industry Report (see “Inside the Laboratory Industry,” Laboratory Industry Report, p. 4, 3/17/16), the diagnostics industry is going global. The Centers for Medicare & Medicaid Services (CMS) recognizes this trend and posted a document on its website entitled “International Laboratory CLIA Certification Process” that provides a blueprint for labs operating outside the United States to legally accept and process samples from the U.S.

ImmunID, a diagnostics company that provides immune molecular diagnostics services to assist clinicians in providing personalized immunotherapy to cancer patients, announced this month that it has received certification from CMS under the Clinical Laboratory Improvement Amendments (CLIA) for a laboratory located in Grenoble, France.

CMS explains on its website that human specimens collected in the United States or its territories and laboratories that perform tests on those specimens are subject to CLIA regulation. An international laboratory for purposes of CLIA certification is one located outside the U.S. (or its territories) that performs lab tests on human specimens when the test is referred by and results are reported to a person or facility located in the U.S. (or its territories).

ImmunID’s new certification authorizes the company to receive and test specimens received from inside the United States using its ImmunTraCkeR® Dx assay. “We are proud to be the first French company to receive this lab certification from the US Department of Health and Human Services’ CMS and are very excited to start providing American doctors with a medical routine assay to evaluate their patients’ immune status,” said ImmunID Chairman and Chief Executive Officer Dr. Bernhard Sixt, in a statement. ImmunID explains that its ImmunTraCkeR® Dx assay focuses on the patient’s immune system rather than the drug or disease.