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Prodesse Files for FDA OK for C. Difficile Assay

Feb 03, 2009

NEW YORK (GenomeWeb News) – Prodesse today said that it had filed for US Food and Drug Administration clearance of its molecular diagnostics assay for Clostridium difficle.

The Milwaukee, Wis.-based firm said that it had filed for 510(k) clearance of the ProGastro Cd Assay following clinical trials conducted at several clinical labs in the US. The assay is already being used for clinical diagnostics in Europe, and additional studies of the test are currently being conducted in the UK.

Prodesse Quality Officer Kristine Schraufnagel said that clinical trials on the ProGastro Cd Assay "easily met our clinical goals for sensitivity and specificity." The test provides results in as few as three hours, the firm said.

Prodesse also said that it has completed clinical trials on its ProParaFlu Assay and expects to submit a 510(k) filing with the FDA within the next 120 days.

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