Date: 2015-06-11
Type of information: Publication of results in a medical journal
phase:
Announcement: publication of results in Transplantation
Company: Eurofins Scientific (Luxembourg)
Product: ImmuKnow® test
Action
mechanism: ImmuKnow® is an immune cell function assay that detects cell-mediated immunity in an immunosuppressed population. The assay detects cell mediated immunity by measuring the concentration of ATP from CD4 cells following stimulation. ImmuKnow® is FDA cleared for the detection of cell-mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.
Disease: solid organ transplantation
Therapeutic area: Transplantation
Country:
Trial
details: The prospective, randomized, controlled, blinded, interventional study involved 202 adult liver transplant recipients. Patients were divided into two groups; 102 patients received standard immunosuppressive therapy (control group) and 100 patients received adjustments to therapy based on their cell-mediated immune responses determined by the ImmuKnow assay (interventional group). In the interventional group, patients were tested with the ImmuKnow assay before liver transplantation, immediately after surgery and at each clinic visit occurring at approximately day 1, weeks 1 to 4, 6 and 8 and months 3 to 6, 9 and 12. The assay was repeated within 7 days of a suspected or confirmed rejection or infection, and again within one week after resolution of the event.
Latest
news: * On June 11, 2015, Eurofins Scientific, a global leader in bio-analytical testing and genomic services, has presented the results from a recent study published in Transplantation (1), showing that Viracor-IBT’s ImmuKnow, the FDA-cleared immune cell function assay that detects cell-mediated immunity in immunosuppressed patients, helps improve outcomes in solid organ transplant (SOT) patients. The study demonstrated that the ImmuKnow assay provided additional data which helped optimize immunosuppression, and ultimately improve patient survival The study involved 202 adult liver transplant recipients. Patients were divided into two groups; 102 patients received standard immunosuppressive therapy (control group) and 100 patients received adjustments to therapy based (1) (Ravaioli M, Neri F, et al. Immunosuppression Modifications Based on an Immune Response Assay: Results of a Randomized, Controlled Trial. Transplantation. Epub* March 9, 2015.)
rate.
Results from the study show the ImmuKnow assay provides a useful biomarker which enables optimizing
immunosuppression to improve patient outcomes by preventing bacterial and fungal infections, reducing immunosuppressant drug use and improving 1-year patient survival. The use of the ImmuKnow assay in a hospital’s immunosuppression protocol can therefore increase the success rate in organ transplantation.
Specifically, the study showed that the use of the ImmuKnow assay helped (1) increase patient survival by 13% one year post-transplant (2) decrease infections over 2 weeks post-transplant; and (3) lower immunosuppressant drug dosage (tacrolimus).
on their cell-mediated immune responses determined by the ImmuKnow assay (interventional group). Based on immune function values, tacrolimus doses were reduced 25% when values were less than 130 (low immune cell response) and increased 25% when values were greater than 450 (strong immune cell response). This means that physicians are able to adjust the amount of the immunosuppressant drug, tacrolimus, to a more optimal, patient-specific level, helping maintain the critical balance between reducing organ rejection and patient infections. The study concludes that ImmuKnow provides a useful biomarker which enables optimizing immunosuppression to improve
patient outcomes by preventing bacterial and fungal infections, reducing immunosuppressant drug use and improving 1-year patient survival.
