QIAGEN has announced the validation of new and improved sequencing chemistry for its GeneReader NGS System, the world's first complete Sample to Insight solution making the benefits of next-generation sequencing (NGS) accessible to any laboratory.
QIAGEN published new, excellent performance data of the QIAGEN GeneReader NGS System using the new sequencing chemistry and QIAGEN's GeneRead QIAact Actionable Insights Tumor Panel.
Data generated from the GeneReader NGS System with the new chemistry showed 100% concordance with results of QIAGEN's FDA approved therascreen KRAS RGQ PCR assay, the company's CE-labelled therascreen RAS Extension Pyro Assay as well as with an alternative next-generation sequencing (NGS) sequencer from another vendor.
In this study, 42 metastatic colorectal cancer FFPE samples were tested with previously confirmed RAS mutational status.
The new sequencing chemistry is based on new and proprietary formulations. It is part of a broad and deep development pipeline of expansions and enhancements to the GeneReader workflow.
QIAGEN is resuming commercialization of the GeneReader NGS System in the United States in early 2017 and will showcase the Sample to Insight sequencing solution together with performance data and other technologies at Booth 1119 at the Association of Molecular Pathology (AMP) 2016 Annual Meeting from November 10-12 in Charlotte, North Carolina.
The new GeneReader chemistry will be made available to select customers in the U.S. as part of an early access phase starting December 1, 2016, followed by broad commercial launches in the U.S. in the first quarter 2017 and in other regions of the world during the second quarter of 2017.
"We are pleased to make the GeneReader NGS System using the new chemistry available again to U.S. customers. Customers in the United States will very soon have full access to our user-friendly, complete solution that delivers reliable sample to insight next-generation sequencing," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V.
"We remain convinced of our intellectual property positions on our legacy GeneReader chemistry. That said, we are very proud to be able to today unveil a completely new and different chemistry with even further enhanced sequencing performance characteristics.”
QIAGEN's fast reaction to the preliminary restriction of customers' access to a superior Sample to Insight solution is a testament to the depth and breadth of our technology and intellectual property portfolio.
“And it demonstrates the capabilities, dedication and commitment of our teams to bringing the experience of Sample to Insight sequencing to customers and allowing them the choice they deserve."
Relaunch of the GeneReader NGS System for U.S. customers is made possible because QIAGEN accelerated several upgrade programs to the sequencing chemistry, including a replacement of the very chemical group that is under dispute in a competitor's pending patent litigation.
Launched in late 2015 for basic and translational research, the GeneReader NGS System is the first truly complete Sample to Insight workflow based on NGS technology.
In June 2016 QIAGEN announced the expansion of GeneReader for use with non-invasive liquid biopsies, adding to its use with FFPE tissue samples. Sample and library preparation steps for the GeneReader NGS System are automatable either on QIAcube or QIAsymphony SP as a front-end.
QIAGEN will provide more information on the GeneReader NGS System at its Investor and Analyst Day, which will be held in New York City on November 15, 2016.