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FDA Clears Thermo Fisher's BRAHMS PCT Assay for Expanded Use

 NEW YORK (360Dx) – Thermo Fisher Scientific business BRAHMS today announced it received 510(k) clearance for expanded use of the firm's procalcitonin-sensitive Kryptor assay for antibiotic resistance.

The clearance provides clinicians in emergency departments, intensive care, and other hospital units with a tool for antibiotic stewardship, BRAHMS said, adding the assay will help clinicians decide whether to start patients with suspected or confirmed lower respiratory tract infections (LRTI) on antibiotic therapy. It also will allow them to determine when patients with LRTI and sepsis can be safely taken on therapy.

The PCT assay was previously cleared for clinical use in the FDA and has been shown to reduce antibiotic prescription rate and duration in patients with LRTI, defined as community-acquired pneumonia, acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease, BRAHMS said.