HOUSTON, March 31 /PRNewswire/ — SeqWright Inc. today congratulated Third Wave Technologies Inc., Madison, Wis., on the successful FDA clearance of its InPlex(TM) CF Molecular Test. CLIA-certified SeqWright is a leader in the field of contract genomics and provided the FDA-level genotyping that ultimately validated the InPlex(TM) CF test by demonstrating it had 99.96% overall agreement with DNA sequencing. The validation played a critical role in the test gaining FDA clearance. SeqWright was responsible for providing the sequence verification for 19 cystic fibrosis (CF) variants from numerous patient samples.
The success of SeqWright’s collaboration with Third Wave builds on a relationship established in 2004, when the two companies began work on Third Wave’s UGT1A1 Molecular Assay. SeqWright provided FDA-level sequencing to validate the UGT1A1 pharmacogenetic test, which is used to identify patients susceptible to adverse reaction from a specific colorectal cancer treatment. The assay gained FDA clearance in August 2005. SeqWright was selected for the sequencing-based validation of Third Wave’s InPlex(TM) CF test after the exemplary work it performed with Third Wave’s UGT1A1 Molecular Assay.
“We are grateful for the contributions SeqWright has made to Third Wave’s two successful FDA submissions,” said Kevin T. Conroy, president and chief executive of Third Wave.
SeqWright CEO, Fei Lu, M.D., said, “We are proud of the success of our past and present collaborations with Third Wave Technologies and we are excited to be involved in the validation of these important diagnostic tests.”
About SeqWright:
SeqWright Incorporated is a world-class genomic services support organization based in Houston, TX with more than a decade of experience specializing in providing access to state of the art Molecular Biology and Genomic services in a highly regulated GLP/CLIA environment. For additional information about SeqWright and its services, please visit http://www.seqwright.com/.
About Third Wave Technologies:
Third Wave develops and markets molecular diagnostic reagents for a variety of DNA and RNA analysis applications to meet the needs of our customers. The company offers a number of products based on its Invader(R) chemistry for clinical testing. Third Wave offers in vitro diagnostic kits, and analyte specific, general purpose, and research use only reagents for nucleic acid analysis. For more information about Third Wave and its products, please visit the company’s website at http://www.twt.com/.
First Call Analyst:
FCMN Contact:
Source: SeqWright Inc.
CONTACT: Marc Dantone of SeqWright Inc., +1-713-528-4363,
mdantone@seqwright.com
Web site: http://www.seqwright.com/
http://www.twt.com/
