FDA OKs bioMerieux' ICT sepsis assay
French in vitro diagnostics firm bioMerieux says it has received clearance from the US Food and Drug Administration to maket its Vidas BRAHMS PCT assay product. The kit, which provides an indication of a patients' risk of progressing from serve sepsis to septic shock, will be used to assess those admitted to intensive care units.
The suite of assays covered by the product includes an automated measure of procalcitonin, a pro-hormone biomarker that is present in an individuals bloodstream during bacterial infection. The kit was launched in Europe in March.
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