Charles River Endosafe Trillium rCR cartridges

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.'

NOTE: This item is from our 'historic' database and may contain information which is not up to date.

Source : Prodesse Inc. View archived contact details

Posted on May 6, 2008

Neogen introducing Veratox VIP for Walnut

RapidChek Total Protein - Detect as low as 3 microgram protein residue in 30 seconds

PDA Alternative Microbiological Methods Workshop 2024

Download the rapidmicrobiology media kit 2024 and discover what your marketing team can achieve

Pharma Microbiology Congress 2024

Get our eNewsletter
Over 7,000 microbiology professionals get our weekly eNewsletter - subscribe now and find out why!