Qiagen NV, Hilden, Germany, has recently announced the validation of new and improved sequencing chemistry for its GeneReader next-generation sequencing (NGS) system.

Supporting its announcement, the company published new performance data for the Qiagen GeneReader NGS system and the GeneRead QiaAct actionable insights tumor panel using the new sequencing chemistry. To obtain updated performance data, a study tested 42 metastatic colorectal cancer formalin-fixed, paraffin-embedded (FFPE) tissue samples with previously confirmed RAS mutational status.

Data generated from the GeneReader NGS system with the new chemistry showed 100% concordance with results from Qiagen’s FDA-approved Therascreen KRAS RGQ polymerase chain reaction assay, with results from the company’s CE-labeled Therascreen RAS extension pyro assay, and with results generated using an alternative NGS sequencer from another vendor.

The new sequencing chemistry is based on new and proprietary formulations, and is part of a broad and deep development pipeline of expansions and enhancements to the GeneReader workflow.

Qiagen expects to resume commercialization of the GeneReader NGS system in the United States in early 2017. The new GeneReader chemistry was made available to select customers in the United States as part of an early access phase starting in December 2016, and will be followed by broad commercial launches in the United States in the first quarter of 2017 and in other regions of the world during the second quarter of 2017.

Peer Shatz, Qiagen.

Peer M. Shatz, Qiagen.

“We remain convinced of our intellectual property positions on our legacy GeneReader chemistry,” says Peer M. Schatz, chief executive of Qiagen. “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.”

Relaunch of the GeneReader NGS system for US customers was made possible because Qiagen accelerated several upgrade programs to its sequencing chemistry.

Launched in late 2015 for basic and translational research, the GeneReader NGS system is a sample-to-insight workflow based on NGS technology. In June 2016, the company announced the expansion of GeneReader for use with noninvasive liquid biopsies, adding to its use with FFPE tissue samples. Sample and library preparation steps for the GeneReader NGS system are automatable on either QiaCube or QiaSymphony SP as a front-end.

For further information, visit Qiagen.