New & Noteworthy

July-August 2018

PCT Assay Receives FDA Clearance

Fujirebio US, Inc

Fujirebio Diagnostics has received US FDA clearance of the Lumipulse G BRAHMS PCT Assay for testing on its LUMIPULSE G1200 immunoassay platform. Procalcitonin (PCT) is a biomarker specific to bacterial infections, offering advantages as an aid to guide antibiotic treatment decisions or to assess the risk of critically ill patients for progression to sepsis or septic shock. When run on the LUMIPULSE G1200 immunoassay platform and used in conjunction with other laboratory findings and clinical assessments, the system can aid in decision-making for patients with suspected or confirmed lower respiratory tract infections. With a precise assay, clinicians can more accurately determine the change in PCT levels and therefore, the effectiveness of antibiotics.

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