ImmunID, the immune companion diagnostics for precision medicine company, today announced certification from the US Department of Health and Human Services’ Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) for its laboratory in Grenoble, France.
Under CMS, the CLIA program regulates laboratories that perform testing on patient specimens from the United States to ensure accurate and reliable test results.
The CLIA certification allows ImmunID to begin receiving and testing specimens from the United States with the ImmunTraCkeR® Dx assay.
“This is a critical regulatory and commercial milestone for ImmunID” said Dr Bernhard Sixt, Chairman and Chief Executive Officer of ImmunID. “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”, he added.
About ImmunID
ImmunID adds precision to the immuno-oncology revolution by personalizing immunotherapy for cancer patients. With its decade-long experience in immune molecular diagnostics, ImmunID provides doctors with clinically meaningful data on the highly complex immune system to select the right therapy for individual patients and to monitor their response. ImmunID’s flagship product, ImmunTraCkeR®, evaluates the patient’s immune status based on the T lymphocyte diversity, from a simple liquid biopsy. Through its PredictID clinical programs, ImmunID is establishing ImmunTraCkeR® as the immune companion diagnostic assay for immune checkpoint inhibitors and other cancer immunotherapies. ImmunID also collaborates with pharma and biotech companies to optimize the development of their next-generation immunotherapies. In addition, through its CLIA services, ImmunID provides its laboratory developed test ImmunTraCkeR® Dx to American doctors to evaluate their patient’s immune status. ImmunID is ISO 9001 and ISO 13485 certified and runs a CAP-accredited, CLIA-certified laboratory in the MINATEC high-tech campus in Grenoble, France.
About ImmunTraCkeR® and ImmunTraCkeR® Dx
ImmunTraCkeR® is a proprietary immune molecular diagnostics assay, which evaluates a patient’s immune status in the blood based on combinatorial T cell diversity. Unlike most companion diagnostics tests, ImmunTraCkeR® is patient-specific rather than drug- or disease-specific, as it approaches the disease from the patient’s own immune system perspective.
ImmunTraCkeR® is currently being validated as immune companion diagnostics for cancer immunotherapy in the PredictID clinical programs. ImmunTraCkeR® aims at overcoming the current challenges in immuno-oncology: personalizing cancer immunotherapy to allow patients to receive efficient treatments, while sparing them from side effects and saving unnecessary costs to the healthcare system.
ImmunTraCkeR® Dx is a laboratory developed test available to doctors in medical routine through ImmunID’s CLIA services. ImmunTraCkeR® Dx is CE-marked.
Biotechin.Asia 