CMS Grants International CLIA Certificate to ImmunID for Laboratory in France

Recognizing a trend in the diagnostics industry with an increasing number of global transactions, deals and partnerships, (see “Inside the Laboratory Industry,” Laboratory Industry Report, p. 4, 3/17/16), the Centers for Medicare & Medicaid Services (CMS) is providing a process for CLIA certification of foreign laboratories processing specimens from the U.S.

CMS has posted a document on its website entitled “International Laboratory CLIA Certification Process” that offers a blueprint for labs operating outside of the United States to legally accept and process samples from the U.S.

CMS’ web page “How to Apply for a CLIA Certificate, Including International Laboratories” instructs that laboratories outside the U.S. or its territories seeking CLIA certification should first contact CLIA-IOIntake@ before completing the certification application form.

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 Improvements 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.

Takeaway: Globalization of the diagnostics industry continues with ImmunID receiving CLIA certification for its laboratory in France.


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