FDA clears test to help manage antibiotic treatment for lower respiratory tract infections and sepsis
The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay...
Biomarkers guide safe antibiotic decisions
Overuse of antibiotics is a global problem, but the biomarker Procalcitonin (PCT), such as the B·R·A·H·M·S PCT assay from Thermo Fisher Scientific, can help guide antibiotic stewardship and reduce resistance to the effects of these drugs.
September 26, 2016
Thermo Fisher Scientific Joins Sepsis Alliance in Support of Sepsis Awareness Month
Sepsis Awareness Month aims to provide education around a deadly condition that is claiming millions of lives globally every year.
Thermo Fisher Scientific has joined the Sepsis Alliance and advocates to spread the word about sepsis and the risk factors associated with the condition.
July 7, 2016
Innovative trial design helps accelerate FDA clearance process for B·R·A·H·M·S PCT license partners
An innovative trial design helped our license partners, Roche Diagnostics USA and bioMérieux, achieve FDA clearance in just 90 days for the Roche ELECSYS B·R·A·H·M·S PCT and bioMérieux VIDAS B·R·A·H·M·S PCT assays. The Procalcitonin MOnitoring SEpsis Study (MOSES) included 858 adult patients with sepsis recruited across 13 investigational sites in the U.S.
June 23, 2016
Roche receives FDA clearance for Elecsys B·R·A·H·M·S PCT
Roche announced that it has received 510(k) clearance for its Elecsys B·R·A·H·M·S PCT (Procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock.
March 1, 2016
Expanded FDA clearance for B·R·A·H·M·S PCT sepsis biomarker
Thermo Fisher Scientific Inc. has received clearance from the U.S. Food and Drug Administration (FDA) that expands the clinical claims of the Thermo Scientific B·R·A·H·M·S PCT (Procalcitonin) biomarker assay for sepsis risk assessment. Clinicians can now use B·R·A·H·M·S PCT to help assess the response of septic patients to treatment by comparing a baseline PCT measurement with a PCT value taken on day four.