SeqWright's Clinical Trial Support Contributes To The Approval Of Two HPV Diagnostic Systems

Main Category: Cervical Cancer / HPV Vaccine
Also Included In: Clinical Trials / Drug Trials
Article Date: 08 Apr 2009 - 0:00 PDT

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SeqWright Inc., an international leader in the field of contract genomic services, announced today its involvement in Hologic's (formerly Third Wave Technologies) successful clinical trials of two Human Papillomavirus (HPV) in vitro diagnostic tests. SeqWright provided FDA submission quality DNA sequencing of multiple HPV strains and bioinformatics support to validate two Hologic HPV diagnostic tests; Cervista HPV High Risk (HR) and Cervista HPV 16/18, in preparation for FDA submission. Both tests were recently awarded FDA premarket approval. According to Hologic, their Cervista HPV HR clinical trial involved over 4,000 women spread across 89 sites throughout the United States and constituted one of the largest and most demographically diverse clinical trials ever conducted in the United States.

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."

About SeqWright:

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.

Source: SeqWright Inc.