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FDA Clears Diazyme Sepsis Dx

NEW YORK (360Dx) – Diazyme Laboratories today said that the US Food and Drug Administration has provided 510(k) clearance to the company to market its procalcitonin assay for diagnosing sepsis.

The homogenous immunoturbidimetric PCT assay can be used on most clinical chemistry analyzers to measure PCT levels in serum and plasma samples, providing results in minutes, Diazyme said. Procalcitonin is a propeptide synthesized in the C-cells of the thyroid and can be clinically useful for diagnosing sepsis. In healthy individuals, PCT levels are very low, with rising levels detectable two to six hours after infection.

"Having the ability to run Diazyme's PCT test on virtually any clinical chemistry analyzer allows users a new flexible and cost-effective option that can be easily integrated into their current laboratory workflows," Diazyme Managing Director Chong Yuan said.