The U.S. Food and Drug Administration on Feb. 23 approved the expanded use of Vidas Brahms PCT Assay.
The diagnostic tool — manufactured by the French biotechnology company bioMérieux — can now be used to help clinicians make antibiotic treatment decisions for patients with sepsis or lower respiratory tract infections. The tool can be used in the hospital or the emergency room.
The test is the first to use a protein called procalcitonin, which is associated with the body's immune response to infections, as a biomarker to inform decisions pertaining to antibiotic treatment.
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High levels of PCT suggest a bacterial infection, while low levels suggest possible viral infection. Sepsis and lower respiratory tract infections can often be caused by bacteria, though viruses and noninfectious diseases can produce similar symptoms.
"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," said Mark Miller, MD, CMO at bioMérieux. "The goal is to achieve better outcomes for patients and to ensure that each of them receives the appropriate treatment."
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