ProGastro™ Cd Gives Labs a User-Friendly Molecular Option for C.diff
Prodesse, Inc. has received 510(k) clearance from the FDA to market its ProGastro™ Cd Assay as an in vitro diagnostic product in the United States.
The clearance came in less than 90 days from submission. ProGastro Cd uses real-time PCR technology; it is simple to use and easily integrates into existing lab workflow. The product has been optimized for the use of automated extraction technology so that its inhibition rate is extremely low. A result can be obtained in as little as 3 hours using the assay.
Clinical trials were conducted at three clinical laboratories in the US. They reported that ProGastro Cd was easy-to-use and that it rapidly and accurately detected toxigenic strains of Clostridium difficile.
In its clinical trials, ProGastro Cd detected 43% more positives than did the current gold standard, the cell cytotoxin assay. Genetic sequencing confirmed that over 90% of the additional positives detected by ProGastro Cd were accurate. In addition, there were no inhibited samples reported by the three clinical sites.
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Source : Prodesse Inc. View archived contact details
Posted on April 20, 2009