Assay for Measuring Cell-Mediated Immunity

The assay has been cleared by the US Food and Drug Administration (FDA), the first product cleared by the FDA for measuring global cell-mediated immunity.

Described as an in vivo bio-assay for drug activity, the test is designed to be used as an adjunct to drug-level monitoring following transplantation. The assay measures the concentration of adenotriphosphate (ATP) from circulating CD4+ cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune function. The test was developed by Cylex, Inc. (Columbia, MD, USA). The company expects its platform technology to become the standard for measuring immune system function in a wide range of applications. The use of whole blood as the sample is especially effective since the most widely used immunosuppressive drugs are found in red cells.

"This clearance is not only a major milestone for the company but physicians now have a method that allows them to rapidly assess an individual patient's immune status at any point in time,” said Judith A. Britz, president and CEO of Cylex.



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