Prodesse's ProFlu+™ Assay Gains Special 510(k) Clearance Modifications
The FDA has authorized two significant changes to Prodesse's ProFlu+™ Assay package insert. The ProFlu+ Assay was originally cleared by FDA on January 4, 2008. The bioMerieux NucliSENS® easyMAG™ automated nucleic acid extraction system has been added as an acceptable extraction method. This is the first infectious disease assay to be cleared in conjunction with the easyMAG.
Additionally, the FDA has removed their recommendation that negative results for Influenza A and Influenza B be confirmed by culture. This is the first - and only - molecular test for respiratory viruses for which FDA has determined that such backup testing is not necessary. FDA recommendations for backup testing can act as requirements in some states.
Prodesse CEO Tom Shannon remarked, 'The inclusion of the easyMAG in our package insert is quite helpful as this instrument is becoming the nucleic acid extractor of choice for many of our customers. This also speaks to the quality of the bioMerieux product as an extensive equivalency study and technical file review was necessary to get it added to the insert. The second modification, the removal of the culture backup recommendation, is also extremely important. Because culture is considered the gold standard´ for respiratory viruses, only a test that shows exceptional performance compared to culture can have this recommendation removed. Our clinical trial sites detected 46% more positives than culture when using our ProFlu+ Assay; further testing by genetic sequencing determined that nearly 90% of the 103 discrepant samples were likely true positives.
We appreciate the FDA being out in front of this issue and recognizing that well-designed molecular tests may, in fact, outperform culture.'
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Source : Prodesse Inc. View archived contact details
Posted on May 6, 2008