FDA Clears bioMérieux System for Microbial Identification and Susceptibility Testing
The automated VITEK PRO platform will replace VITEK 2 and VITEK XL, with a US commercial launch planned for early 2027.
The automated VITEK PRO platform will replace VITEK 2 and VITEK XL, with a US commercial launch planned for early 2027.
The system began patient testing Nov 2, initially focusing on vitamin and hormone assays, with plans to expand into therapeutic drug monitoring and toxicology.
The agreement covers an ESR1 mutation detection kit for metastatic breast cancer and a DPYD genotyping kit for assessing chemotherapy toxicity risk.
The kit allows laboratories to extract DNA and RNA from a range of clinical specimens using a single method.
The research-use-only assay combines two key genetic markers for acute myeloid leukemia in a single test, potentially reducing the need for separate testing workflows and reference lab send-outs.