German-based developer of T-cell based diagnostic testing systems Lophius Biosciences has completed a prospective multicentre clinical validation study for its T-Track CMV / EBV tests.

The potential of T-Track CMV / EBV tests with respect to determination of functional effector cells of cell-mediated immunity has been examined 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 Lophius Biosciences was able to develop a simple biostatistical method for T-cell based tests, which will allow comparative analysis between different patient groups in the future.

Bernhard Banas, University Hospital Regensburg Nephrology and Transplantation Center department head, said in connection with the high degree of standardisation, both test systems may be key for a personalised therapy in transplantation medicine, with the aim to improve transplantation outcomes and reduce negative therapeutic effects.

Lophius Biosciences chief scientific officer Ludwig Deml said the development of a standardised tool for cell-mediated immune response will allow a user-friendly monitoring of the immune status of immune-compromised patients.

Michael Lutz, Lophius Biosciences CEO, 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.

Lophius Biosciences develops and markets T-cell based testing systems for diagnostics and possible therapy control in the fields of transplantation, infection and autoimmune diseases.