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FDA Clears Beckman Coulter's Procalcitonin Assay

NEW YORK – Beckman Coulter announced Tuesday that the US Food and Drug Administration granted 510(k) clearance to its Access PCT assay, allowing it to be sold in the US.

The in vitro diagnostic test allows physicians to assess critically ill patients who may be in danger of progressing to severe sepsis or septic shock by measuring procalcitonin levels in blood.

"Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections, and also with the probability of a positive blood culture, making it a clinically useful marker in the assessment of patients with possible sepsis or at risk of progressing to septic shock," said Shamiram Feinglass, Beckman Coulter's chief medical officer. "The ability to rapidly diagnose suspected sepsis patients and determine care and treatment is critical, as earlier administration of appropriate antibiotics is highly correlated with increased patient survival."

The assay integrates procalcitonin testing into routine sepsis workups on core laboratory analyzers as a primary or reflex test programmed through Beckman Coulter's Remisol Advance middleware, the company said in a statement. Access PCT is available for use on Beckman Coulter's Access family of immunoassay systems, including the Access 2, UniCel Dxl 600, and UniCel Dxl 800.

Last year, the Brea, California-based company, which is a part of Danaher, was awarded $1.25 million from the US Department of Health and Human Services, Biomedical Advanced Research and Development Authority, Division of Research, Innovation, and Ventures to develop a sepsis detection algorithm.