Lophius Biosciences has announced the successful completion of a prospective multicenter clinical validation study for its T-Track® CMV/EBV tests.
In cooperation with four dialysis centers in Germany (Regensburg, Mannheim, Straubing and Landshut) the ability of both T-Track® CMV/EBV tests with respect to determination of functional effector cells of cell-mediated immunity was successfully examined during 4th quarter 2011 in a cohort of > 120 hemodialysis patients.
Using standard statistical analysis tools, the clinical sensitivities were 100% for T-Track® CMV and 97% for T-Track® EBV in this cohort.
Based on the study results Lophius Biosciences was able to develop a novel simple biostatistical method for T-cell based tests, which should allow comparative analysis between different patient groups in the future.
This is a key prerequisite for the use of both T-Track® CMV/EBV tests for a routine immune monitoring. Using this novel tool, clinical sensitivities were 88% for T-Track® CMV and 86% for T-Track® EBV.
“We were very impressed with the high clinical sensitivities for both T-Track® CMV and T-Track ® EBV Tests“, said Prof. Dr. Bernhard Banas, Department Head of Nephrology und Transplantation Center of the University Hospital Regensburg.
Prof. Banas continued, “In connection with its high degree of standardization, both test systems may be key for a personalized therapy in transplantation medicine, with the aim to increase transplantation outcome and reduce negative therapeutic effects”.
“We are delighted that we were able as part of the validation study to develop an analysis tool for the first time that may set the basis for a standardized measurement of cell-mediated immune response. This should allow a user-friendly monitoring of the immune status of immune compromized patients e.g. after transplantation, but also in other indications” added PD Dr. Ludwig Deml, CSO of Lophius Biosciences.
Dr. Michael Lutz, CEO of Lophius Biosciences, said: “The successful completion of both test developments for both T-Track® CMV and T-Track® EBV tests in a short timeframe underpins the high innovative potential of our proprietary technology platform. This could set the basis for novel T-cell based diagnostic systems in areas with high medical need”.
Lophius Biosciences will present the study results at the world biggest transplantation conference (TTS) in Berlin in July 2012.
Moreover, the company aims to publish the study results as quickly as possible in a leading scientific journal.