The diagnostics division of Bayer HealthCare has won CE Mark approval for its Trugene HIV-1 genotyping kit. The test, cleared by the US Food and Drug Administration in September 2001, is the first HIV-resistance product to be approved in the European Union under the European Commission’s IVD Directive.
The Trugene assay detects HIV mutations known to make certain antiretroviral drugs ineffective, the company said.
Applied Biosystems has launched a pair of new real-time PCR systems. The tools, the 7300 and 7500 real-time PCR systems, enable researchers to perform gene expression analysis, pathogen quantitation, and SNP genotyping, ABI said. The company added that the systems do not require scientists to run gels, purify PCR products, or perform any post-PCR manipulation.
Both products can run TaqMan Assays-on-Demand or Assays-by-Design for gene-expression analysis or SNP genotyping.
CombiMatrix has rolled out its microarray for the detection of the H5N1 Bird Flu influenza A virus after the World Health Organization on Jan. 27 asked the company for help. The company used its probe-design software to develop the array “within two days” of the WHO’s plea, CombiMatrix said.
The company said its array not only identifies the H5N1 virus, but also enables public health officials to track any mutations that may develop.