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FDA Clears Roche's PCT Assay for Expanded Use

NEW YORK (360Dx) – The US Food and Drug Administration has cleared Roche's Elecsys BRAHMS PCT assay for an expanded use to aid in antibiotic therapy decision-making, the company announced on Friday.

The Elecsys BRAHMS PCT is an electrochemiluminescence immunoassay for determining procalcitonin levels in human serum or plasma. The assay was previously cleared by the agency in 2016 for evaluating the progression of patients to severe sepsis and septic shock and 28-day mortality after diagnosis. The expanded FDA clearance allows it to be used by clinicians to support treatment decisions in patients with suspected or confirmed sepsis and suspected or confirmed lower respiratory tract infections, defined as acute exacerbations of chronic obstructive pulmonary disease, community-acquired pneumonia, and acute bronchitis, Roche said.

It noted that the assay can be added to any of the company's Cobas immunoassay instruments.

"With this assay's expanded claims, clinicians now have an important tool in the battle against antibiotic resistance and are better equipped to provide patients the right treatment for the right period of time," Roche Diagnostics CMO Alan Wright said in a statement.