Roche has received 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay as a dedicated testing solution for people with severe sepsis or septic shock. With this clearance, Roche is the first IVD company in the US to provide a fully integrated solution for sepsis risk assessment and management.
PCT is a sepsis-specific biomarker associated with bacterial infection and PCT levels in blood can aid clinicians in assessing the risk of sepsis as well as managing the disease when present. The Elecsys BRAHMS PCT assay can aid in assessing the risk of critically ill patients to progress from severe sepsis to septic shock; and help determine the 28 day mortality risk in sepsis patients.
"Given the prevalence of sepsis in the US – more than 1.6 million annual hospitalizations – this clearance is an important advancement in its assessment and management," said Dr. Alan Wright, chief medical officer, Roche Diagnostics North America. "With such compelling clinical utilities and the automation advantages associated with Roche lab instrumentation, the Elecsys BRAHMS PCT test can provide healthcare professionals the confidence they need to manage this deadly disease."
The clearance of Roche's PCT solution is a result of the US multicenter Procalcitonin Monitoring Sepsis Study (MOSES). The novel trial design of Thermo Fisher Scientific's MOSES study leveraged the same patient samples to enable a "universal analysis" approach to demonstrate substantial equivalence to the FDA resulting in the clearance of the Elecsys BRAHMS PCT assay.