Date: 2012-04-25
Type of information: Results
phase:
Announcement: results
Company: Lophius Biosciences (Germany)
Product: T-Track® CMV/EBV Test Systems
Action mechanism:
Disease: CMV (cytomegalovirus) infection
EBV (Epstein-Barr virus) infection
Therapeutic area: Infectious diseases - Renal diseases
Country: Germany
Trial details:
Latest
news: 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. 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.
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..
