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 bioMérieux 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.”
About Prodesse Prodesse is a biotechnology company focused on developing molecular diagnostic reagents for a variety of infectious disease applications. The company’s products are designed based on a combination of Prodesse’s patented technologies and other licensed technologies. Prodesse sells FDA 510(k) cleared products worldwide, CE Marked in vitro diagnostic kits outside the US and research use only kits worldwide. The company’s products can be used on multiple nucleic acid extraction and real-time PCR platforms. Prodesse also operates a CLIA certified laboratory for testing services in the Midwest area. For more information about Prodesse and its products, call 888-589-6974 or go to www.prodesse.com.
Press Contact: Andy Shrago, Chief Marketing Officer Prodesse, Inc. Phone: (262) 446-0700 Email: ashrago@prodesse.com
