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FDA Clears DiaSorin Assay for Quantitative Determination of Procalcitonin

NEW YORK (360Dx) – Saluggia, Italy-based DiaSorin said Thursday that it has received clearance from the US Food and Drug Administration to market the Liaison BRAHMS PCT II Gen assay for the quantitative determination of procalcitonin.

John Walter, president of DiaSorin, said in a statement that the assay is an addition to its "growing specialty menu in the US market" and that the FDA also cleared procalcitonin controls and calibration verifiers for use on its Liaison family of instruments.

According to the company's website, the test uses chemiluminescence immunoassay technology and is intended for use with human serum and plasma samples. In conjunction with other laboratory findings and clinical assessments, the test can be used to evaluate the risk of progression of relevant bacterial infections in critically ill patients.

DiaSorin noted that PCT is a good indicator of the presence of a bacterially-induced systemic inflammatory reaction, and that clinical evaluations in specialized fields of medicine have shown that in vitro determination of PCT can be efficiently used for the diagnosis of sepsis, severe sepsis, and septic shock; the differential diagnosis of clinically relevant bacterial infections and sepsis; the evaluation of the severity of a bacterial infection and systemic inflammatory reactions; the monitoring of the course of treatment of patients with sepsis; and the evaluation of progression and control of antibiotic treatment.