Bayer gets EU nod for Trugene HIV resistance test:
This article was originally published in Clinica
Bayer Diagnostics has CE-marked for sale in Europe its genotypic HIV resistance test. The Trugene HIV-1 genotyping kit is a DNA sequencing assay for detecting HIV genomic mutations that make specific types of antiretroviral drugs ineffective. It was cleared for sale in the US in September 2001 and is the first commercial HIV resistance product to achieve the CE mark certification under the IVD Directive, claims the company.