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Qiagen touts one-stop shop for next-gen sequencing

December 2015—Despite launching years after the next-generation sequencing systems from Illumina and Thermo Fisher, officials at the German molecular biology company Qiagen see an opening for their GeneReader NGS offering.

“Labs struggle with NGS adoption, whether it’s with fragmented workflows or the technical challenges,” says Jonathan Arnold, senior director of marketing at Qiagen, whose North American headquarters are in Germantown, Md. “We’re not launching a sequencer or a box, but launching a complete solution in itself.”

Arnold

The system was unveiled in November at the Association for Molecular Pathology’s annual meeting. It runs a gene panel that targets 12 clinically actionable genes for the most common types of cancer and can detect up to 1,250 genetic mutations in a tumor sample, the company said. The system includes scalable batch sizes and continuous loading of multiple flow cells, and will be offered on a price-per-test commercial model.

“This is the first fully integrated sample-to-insight NGS system,” Qiagen chief medical officer Tadd S. Lazarus, MD, told CAP TODAY on the AMP exhibit floor. “Others have focused on the hardware, the sequencer, to the detriment of sample preparation, library preparation, and most importantly data. You know, these sequencers put out an extraordinary amount of information and, in and of itself, it’s completely meaningless.”

“What we do is we have a report that is fully actionable, and it allows the laboratory to pass on these insights to the physician to use immediately,” Dr. Lazarus added. He says that Qiagen Clinical Insight, the bioinformatics engine of the GeneReader NGS System, delineates which notations are pathological and their significance, the best drugs for treatment, the peer-reviewed literature citations, and the clinical trials in which the patient might be able to enroll.

“It’s really an extraordinary advance,” Dr. Lazarus said.

Dr. Lazarus

The Broad Institute of MIT and Harvard evaluated the GeneReader NGS System and presented its findings at an AMP workshop. The Broad analysis showed that data from the GeneReader NGS System were 100 percent concordant with results of Qiagen’s FDA-approved Therascreen KRAS RGQ PCR assay, as well as its CE-marked Therascreen RAS Extension Pyro Assay. The system scored 100 percent agreement with Illumina’s MiSeq sequencer, and the GeneReader NGS data had fewer FFPE artifacts because it uses a different method of sample extraction.

The Dartmouth-Hitchcock Medical Center also has helped evaluate the Qiagen system. Gregory J. Tsongalis, PhD, is director of Dartmouth’s clinical genomics laboratory.

“The GeneReader system offers another NGS alternative and the precision of Qiagen engineering,” he says. “The panels they have developed are robust, and the menu continues to increase. Qiagen also has the added advantage of being able to provide a true analytical solution for managing the massive amounts of data produced.”

Notwithstanding the big launch at the AMP meeting, the GeneReader NGS System remains research use only for now.

“We’re working closely with these [regulatory] agencies, because this is really the first integrated system and it is rather different than what the agencies have seen before,” Dr. Lazarus said. “It’s a different ballgame.”

Upon FDA approval, Qiagen officials see an opportunity to target smaller laboratories that have held off on NGS due to the cost of sequencing systems, uncertainties over reimbursement, or the lack of bioinformatics expertise. Dr. Lazarus said that some laboratories doing next-gen sequencing work with as many as 15 vendors end to end. Arnold says Qiagen’s system will provide a different model.

“As a vendor, we are offering everything an NGS lab needs to get up to running from scratch,” he says. A laboratory implementing the GeneReader NGS System “doesn’t need a full-time bioinformatician to do this,” Arnold adds.

“Illumina makes a great sequencer—there’s no doubt about that. Thermo does as well. A lot of laboratories that want a sequencer are more than happy to put the pieces together, and they have the capability to do that,” Arnold says. “Basically, we have put the pieces together. And there is a large number of labs that want that or need that.”—Kevin B. O’Reilly

Surgical museum highlights pathologist’s role

In Chicago on CAP business a few years ago, S. Robert Freedman, MD, took the opportunity to visit one of the Windy City’s lesser known attractions, the International Museum of Surgical Science. Housed inside a historic chateau-style mansion on Lake Shore Drive, the museum is devoted to furthering the public’s “understanding of the history, development, and advances of surgery and related subjects in health and medicine.”

Dr. Freedman, a member of the CAP’s Council on Membership and Professional Development, greatly enjoyed the museum’s exhibits and its collection of more than 20,000 medical artifacts. But he was struck by the “conspicuous absence” of information on pathology’s critical role in surgery.