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Cytonics’ licensing partner granted CLIA certification to allow lab testing on human samples
Cytonics is proud to announce that its exclusive licensing partner CAREstream has been granted a CLIA certificate of registration which allows the facility to conduct complex laboratory testing on human samples (blood, tissue, joint fluid, etc).
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing in the U.S. and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC).
CAREstream has the global rights to market, sell, and distribute Cytonics’ patented Autologous Platelet Integrated Concentrate (APIC) system and Fibronectin-Aggrecan Complex Test (FACT) diagnostic assay. These are developed therapies and tests specific for the treatment of pain, inflammation, the degeneration of joints and osteoarthritic pain for human patients.