Thermo Fisher Scientific announced the sixth licensing agreement for its B·R·A·H·M·S PCT (procalcitonin) biomarker that provides information on the presence and severity of bacterial infections. B·R·A·H·M·S PCT aids physicians in emergency departments (ED), intensive care units (ICU) and other hospital specialties in deciding whether to initiate antibiotic therapy in patients with suspected or confirmed lower respiratory tract infections (LRTI) and when to safely discontinue antibiotics in patients with LRTI and sepsis. Siemens Healthineers joins a leading group of healthcare technology partners that includes Abbott, bioMérieux, DiaSorin, Fujirebio and Roche, all of whom are dedicated to continued innovation to aid in early sepsis detection and reducing inappropriate antibiotic use in hospital patients.
Siemens Healthineers Atellica IM B·R·A·H·M·S PCT assay received FDA clearance on July 16, 2018. In clinical studies, B·R·A·H·M·S PCT has been shown to reduce the antibiotic prescription rate and duration in patients with LRTIs such as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Evaluating the decline in B·R·A·H·M·S PCT levels over time aids clinicians in determining whether to discontinue antibiotic therapy for patients with LRTI or sepsis. The Atellica IM B·R·A·H·M·S PCT assay can also aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis, assessing the risk of critically ill patients who progress from severe sepsis to septic shock, and help determine the 28-day all-cause mortality risk in sepsis patients.
In 2016, the biomarker was cleared to use in assessing the risk of critically ill patients who were diagnosed with severe sepsis or septic shock and to help determine the 28-day all-cause mortality risk in sepsis patients. This clearance served to expand use of the biomarker outside of ICU into the ED and General Ward for sepsis and all risk mortality. In 2017, the biomarker was cleared to assist in decision making on antibiotic therapy for patients with suspected or confirmed LRTI in an inpatient setting or an emergency department and to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.
"The Siemens Healthineers Atellica IM B·R·A·H·M·S PCT assay is another example of our commitment to precision medicine and to delivering a comprehensive assay menu for the Atellica Solution," said Andy Olen, senior vice president, Laboratory Diagnostics, North America, Siemens Healthineers. "The Atellica IM B·R·A·H·M·S PCT assay is a good tool as an aid in sepsis assessment, assigning mortality risk, and antibiotic therapy decision making in the ED and ICU. Early diagnosis and treatment of sepsis is associated with better patient outcomes."
"With more than 5,000 customers in 130 countries it is clear that expanding availability of the PCT biomarker benefits patients and communities," said Patrick Durbin, senior vice president and president of specialty diagnostics for Thermo Fisher Scientific. "B∙R∙A∙H∙M∙S PCT offers consistent results across all platforms and helps health care practitioners make safe clinical decisions as they determine whether to initiate, and when to stop, antibiotic therapy in certain patients."