Cylex has reported that the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel has approved the creation of new CPT coding for its ImmuKnow Assay. The decision was based on the clinical value and widespread use of ImmuKnow, and the fact that existing CPT codes insufficiently captured all steps and costs of testing, said the company.

ImmuKnow assay is a qualitative assay and does not directly quantify the level of immunosuppression. Results of the ImmuKnow assay should be used in conjunction with clinical presentation, medical history, and other clinical indicators when assessing the immune status of any individual patient.

ImmuKnow is mapped to CPT Code 86352, ‘Cellular function assay involving stimulation (e.g., mitogen or antigen) and detection of a biomarker (e.g., ATP).’ It is a biomarker of immune function that complements immunomodulatory therapy and helps physicians and other healthcare professionals more effectively manage immunosuppression in posttransplant patients, thereby reducing the risks of infection and rejection by various steps.

ImmuKnow is the FDA-cleared assay that tracks changes in global immune function over time. It is a non-invasive biomarker of immune function that assesses cellular immune status by detecting cell-mediated immunity (CMI) in adult immunosuppressed patients. It measures the concentration of adenosine triphosphate (ATP) released from CD4 cells following cell stimulation.

Brad Stewart, president, CEO and chairman of Cylex, said: “We are pleased by the decision of the AMA to recognize the value of ImmuKnow as a biomarker that provides valuable insight for individualized patient management by establishing a unique CPT code. We look forward to assisting clinicians with continuing to expand the implementation of ImmuKnow as standard of care in more effectively managing their patients’ immunosuppression.”