Back To: Home

CLICK HERE FOR WHAT'S NEW IN:
 




 

HTG completes module three filing for EdgeSeq ALKPlus Assay
April 2017
SHARING OPTIONS:

TUCSON, Ariz.—HTG Molecular Diagnostics Inc., a provider of instruments and reagents for molecular profiling applications, has submitted to the FDA the third of four expected modules for the company’s premarket approval (PMA) application for the HTG EdgeSeq ALKPlus Assay to be used as a companion diagnostic for crizotinib (a drug for treating non-small cell lung cancer). The third PMA module included data from analytical performance studies completed at HTG along with interlab reproducibility study data completed at three trial sites. The company commercialized its HTG Edge instrument platform and a portfolio of RNA assays that leverage HTG’s proprietary nuclease protection chemistry in 2013, and HTG’s product offerings have since expanded to include its HTG EdgeSeq product line.
 
“We are very pleased to meet this milestone for the HTG EdgeSeq ALKPlus Assay PMA submission,” stated TJ Johnson, president and CEO of HTG. “This module three submission was a significant undertaking for the HTG team, and we are now fully focused on completing the fourth and final PMA module early in 2017.”

Back



PAGE UTILITIES


CONTACT US
DDNEWS
Published by Old River Publications LLC
19035 Old Detroit Road
Rocky River, OH USA 44116
Ph: 440-331-6600  |  Fax: 440-331-7563
 
© Copyright 2017 Old River Publications LLC. All righs reserved.  |  Web site managed and designed by OffWhite.