SeqWright's Clinical Trial Support Contributes to the Approval of Two HPV Diagnostic Systems
Published: Apr 07, 2009
SeqWright was selected to perform the sequencing-based validations of Hologic's HPV Diagnostics assays after successfully completing several of Hologic's previous clinical trials, which all led to FDA approvals. SeqWright maintains advanced quality control with a Clinical Laboratory Improvement Amendment (CLIA) certification as well as maintaining compliance with Good Laboratory Practices (GLPs) as specified in the Code of Federal Regulations.
Sequencing for Hologic's clinical trials was performed under GLP guidelines (4X-bidirectional sequencing, stringent controls, full documentation) and all samples were continuously tracked and monitored. The bioinformatics provided by SeqWright were also vital to trial success and were used to implement Hologic's HPV genotyping analysis as well as to create a customized clinical trial decision tree algorithm. These services led to a streamlined, reliable and efficient testing regimen in support of Hologic's two recently approved HPV Diagnostics.
SeqWright CEO, Dr. Fei Lu, M.D. stated, "We wish to congratulate Hologic on the pre-market approvals of their new HPV diagnostic tests and we are proud of the work we performed in support of their efforts."
SeqWright Incorporated is a world-class genomic services support organization based in Houston, TX with more than fifteen years of experience specializing in state of the art Molecular Biology and Genomic services within a highly regulated GLP/CLIA environment. For additional information about SeqWright and its services, please visit www.seqwright.com.