Lophius Biosciences Completes Necessary Regulatory Milestones with EN ISO 13485 Certification
News Jun 01, 2012
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.
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