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FDA Clears Fujirebio Diagnostics G BRAHMS Procalcitonin Assay

NEW YORK (360Dx) – Fujirebio Diagnostics said today that it has received US Food and Drug Administration clearance for use of its Lumipulse G BRAHMS PCT Assay for testing on the Lumipulse G1200 immunoassay platform. 

The test can be used for a range of clinical assessments when it is run on the immunoassay platform and used in conjunction with other laboratory findings and clinical factors, the firm said. It enables decision-making for patients with suspected or confirmed lower respiratory tract infection, and risk assessment for progression to severe sepsis or septic shock of critically ill patients on their first day of being admitted to the intensive care unit.

By measuring changes in PCT levels over time, clinicians can use the assay to assess the cumulative 28-day risk in the ICU of "all-cause mortality" for patients diagnosed with severe sepsis or septic shock, the firm said. Clinicians can obtain the same assessment in the emergency department or other hospital setting prior to the patient being admitted to the ICU. Further, the assay can be deployed to enable decision-making for patients with suspected or confirmed sepsis.

By removing analytical variability of results when the test is used to monitor antibiotic therapy, the assay helps clinicians conform to new guidelines for antibiotic stewardship released by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America, Fujirebio said.

"Serial measurement of procalcitonin levels…can lead to reduced hospitalization stays without adversely affecting patient outcomes," and therefore the assay is "a significant new tool in the fight against sepsis, lowering hospital re-admission rates, and improving the use of antibiotic treatment," Matthew Bell, vice president of sales and marketing at Fujirebio US, said in a statement.