Lophius Biosciences has announced the successful realization of two important regulatory milestones.
With the successful completion of the EN ISO 13485 certification, the company established all prerequisites for a quality management system to meet customer and regulatory requirements applicable to medical devices according to the European IVD guidelines.
In addition, the company has announced that it has received CE-marking for its T-Track® CMV and T-Track® EBV tests following successful clinical validation of both products by measuring functional effector cells of the cell-mediated immune system (CMI) in a cohort of > 120 hemodialysis patients.
Observed clinical sensitivities in this patient cohort were 88-100% for T-Track® CMV and 86-97% for T-Track® EBV respectively, depending on the biostatistical method applied.
“We are very pleased with the successful completion of these important regulatory milestones which round up our development programs for both tests T-Track® CMV and T-Track® EBV. We now have the tools in place to establish full clinical benefits of these novel T-cell based diagnostics in the field of transplantation and other indications with high medical need” said Dr. Michael Lutz, CEO of Lophius Biosciences.