Navigation Links
SeqWright's Clinical Trial Support Contributes to the Approval of Two HPV Diagnostic Systems
Date:4/7/2009

HOUSTON, April 7 /PRNewswire/ -- 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. For additional information about SeqWright and its services, please visit www.seqwright.com.


'/>"/>
SOURCE SeqWright Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. EpiCept Reports Expansion of Clinical Development For Licensed Cancer Compound
4. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
5. Romark Initiates Clinical Trial of Alinia(R) for Chronic Hepatitis C in the United States
6. The Multiple Myeloma Research Consortium (MMRC) and Proteolix Initiate Phase 2 Clinical Trial Investigating Carfilzomib for the Treatment of Multiple Myeloma
7. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
8. Potential Safety Issue Identified in Ongoing Phase 2 Clinical Study of HCV-796
9. Clinical Trial Effectiveness: How Pharmas & Biotechs Save Cost with Savvy Investigator Management
10. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
11. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/17/2017)... 17, 2017  Zimmer Biomet Holdings, Inc. (NYSE and ... today announced that it has implemented a ... the Zimmer Biomet management team. Effective January 23, ... the position of President, Americas and join the ... served as Zimmer Biomet,s Vice President of U.S. ...
(Date:1/17/2017)... Research and Markets has announced the addition of the ... ... laparotomy sponges market to grow at a CAGR of 7.94% during ... 2016-2020, has been prepared based on an in-depth market analysis with ... its growth prospects over the coming years. The report also includes ...
(Date:1/17/2017)... BELLEFONTE, Pa. , Jan. 17, 2017 /PRNewswire/ ... Medical, Inc.(AMI) announces the addition of 6 senior ... of the TubeClear® System.  These sales leaders were ... recently acquired medical device company. Repeatedly recognized for ... of exceeding customer expectations and establishing relationships with ...
Breaking Medicine Technology:
(Date:1/17/2017)... ... 2017 , ... Anesthesia Progress – Everyone wants less pain during ... option for each patient. Dentists have several general anesthesia alternatives and finding the right ... the Tokyo Dental College in Tokyo, Japan wanted to find out which anesthetic was ...
(Date:1/17/2017)... ... January 17, 2017 , ... ... Healthful-Flex. , The company, owned and operated by Ed Stroup, was created ... reasonable price with the highest level of customer service. Healthful Balance products can ...
(Date:1/17/2017)... Clemente, CA (PRWEB) , ... January 17, 2017 ... ... Diego County, as well as Palm Desert, is opening a new office in ... Brainsway deep transcranial magnetic stimulation (dTMS) in Southern California, successfully treating individuals struggling ...
(Date:1/17/2017)... ... 2017 , ... A prescription medication bottle, pocket knife, luggage and a solar-powered ... Product Design Challenge , the Cradle to Cradle Products Innovation Institute has ... scheduled to run through early 2018. The challenges are presented by the Institute in ...
(Date:1/17/2017)... CA (PRWEB) , ... January 17, 2017 , ... Livionex, ... the results of a double blind clinical study for its dental gel that shows ... leading national brand of toothpaste containing triclosan. The study was conducted at the Beckman ...
Breaking Medicine News(10 mins):