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Roche's procalcitonin assay gets FDA approval for sepsis management

MDBR Staff Writer Published 27 June 2016

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Roche's Elecsys BRAHMS PCT (procalcitonin) assay which will be used to aid in the management of sepsis risk.


The assay will evaluate the risk of critically ill patients to progress from severe sepsis to septic shock, allowing to determine the 28-day mortality risk in sepsis patients.

PCT is a sepsis-specific biomarker associated with bacterial infection. Its levels in blood enable clinicians to assess the risk of sepsis and manage the disease when present.

The approval was granted based on the results of the US multicenter procalcitonin monitoring sepsis study (MOSES).

With an incubation time of 18 minutes, the new assay includes a measuring range of 0.02 - 100 ng/mL to 100 ng/mL.

According to Roche, 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 assay.

Roche Diagnostics North America chief medical officer Dr. Alan Wright said: "Given the prevalence of sepsis in the U.S. - more than 1.6 million annual hospitalizations - this clearance is an important advancement in its assessment and management.

"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."

Image: New Roche assay helps in sepsis management. Photo: courtesy of PRNewsFoto / Roche.