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February 26, 2017updated 02 Nov 2021 4:14am

bioMérieux secures FDA 510(k) clearance for Vidas Brahms PCT assay

French-based in-vitro diagnostics firm bioMérieux has secured 510(k) clearance from the US Food and Drug Administration (FDA) for the expanded use of its automated assay Vidas Brahms, to measure procalcitonin (PCT) levels.

French-based in-vitro diagnostics firm bioMérieux has secured 510(k) clearance from the US Food and Drug Administration (FDA) for the expanded use of its automated assay Vidas Brahms, to measure procalcitonin (PCT) levels.

The automated assay can now be used to measure the PCT levels during lower respiratory tract infections (LRTI) and sepsis, which  enables clinicians to determine the optimal use of antibiotics in these conditions.

The approval was based on the results from a prospective, randomised clinical trial that compared PCT-guided therapy to standard therapy.

“The goal is to achieve better outcomes for patients and to ensure that each of them receives the appropriate treatment.”

The results showed that there was a decrease in antibiotic use for patients who had received PCT-guided therapy, without affecting safety.

The assay will help to determine safe reduction of overall antibiotic use in case of patients with LRTI, while it aids decision regarding the safe period for discontinuation of antibiotics in sepsis patients.

bioMérieux corporate vice-president and chief medical officer Mark Miller said: “Antimicrobial resistance is considered as a major threat to public health and this FDA clearance illustrates our capacity to provide clinicians with high medical value tests to help them make important treatment decisions.

“The goal is to achieve better outcomes for patients and to ensure that each of them receives the appropriate treatment.”

The Vidas Brahms PCT assay was initially cleared in 2007 for PCT measurement to detect the risk for sepsis and septic shock on the first day after admission to an intensive care unit (ICU).

Last year, the clearance was extended to include examination of PCT levels serially over 96 hours for the risk of mortality in patients with severe sepsis.

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