Lophius Biosciences, a developer of T-cell based diagnostic testing systems, has concluded a prospective multicentre clinical validation study of its T-Track CMV/EBV tests.
The T-Track CMV/EBV tests ability with respect to determination of functional effector cells of cell-mediated immunity has been evaluated in around 120 hemodialysis patients at four dialysis centres in Germany.
Using standard statistical analysis tools, the clinical sensitivities were determined to be 100% for T-Track CMV and 97% for T-Track EBV.
Based on the study results, the company developed a simple biostatistical method for T-cell based tests, which will allow comparative analysis among different patient groups.
University Hospital Regensburg Nephrology und Transplantation Center department head Bernhard Banas said in connection with the high degree of standardization, both test systems may be crucial for a personalized therapy in transplantation medicine, with the aim to increase transplantation outcome and reduce negative therapeutic effects.
Lophius Biosciences CEO Michael Lutz said the successful completion of both test developments for both T-Track CMV and T-Track EBV tests in a short timeframe highlights the potential of the company’s proprietary technology platform.
"This could set the basis for novel T-cell based diagnostic systems in areas with high medical need," Lutz added.