ImmuKnow™, an immune cell function assay uses the plant lectin phytohemagglutinin (PHA) to stimulate lymphocytes, and measures increases in intracellular adenosine triphosphate (ATP) following activation. Whole blood samples are used to maintain the presence of the drug during overnight incubation, after which CD4 cells are selected using paramagnetic particles coated with a monoclonal antibody to the CD4 epitope. Major immunosuppressive drugs are designed to inhibit T-cell activation; therefore, by comparing stimulated T-cell responses to unstimulated ones, quantitative assessment of the ability of the immune system to respond to stimulation is achievable. The Cylex bioassay, which uses established T-cell reactivity ranges in the assessment of functional immunity for an individual solid organ recipient at any point in time, was cleared by the FDA in 2002.

The ImmunKnow immune cell function assay provides biological end point information useful in assessing the impact of immunosuppressive therapies on patients’ immune systems. With specific measurement data of the status of the immune system obtained for each organ transplant recipient, individualized therapies can be designed to better evaluate the net effect of therapeutic drug treatments and dosage reduction or increases and to better optimize treatment protocols.

Cylex Inc