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With NGS System in Limited Early Access, Qiagen Readying for 2014 Commercial Launch

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This article was originally published Nov. 1.

Qiagen's next-generation sequencing system, GeneReader, is in the hands of several "alpha-beta" customers, and the company plans to expand its early-access program to additional customers this year with a full commercial launch planned in 2014, Qiagen CEO Peer Schatz said last week during a conference call discussing the company's third quarter results.

Qiagen is taking a "two-pronged" approach to the next-generation sequencing market. On the one hand, it is "offering many products as universal solutions … that can be used on any NGS detection platform," Schatz said. For instance, last year it launched a number of cancer gene panels, and Schatz said this week that it will launch 20 panels by the end of the year.

On the other hand, the firm is "advancing our own GeneReader benchtop sequencer, which will use these products as well, but integrate them into a seamless work screen from Qiagen, as we say, from sample to insight," Schatz said.

The GeneReader system is currently in the hands of a few early customers, and feedback from those customers has been positive, Schatz said. "We are aiming to release it to further select customers later in 2013, and are preparing for broad commercialization in 2014."

Qiagen's GeneReader system is based on technology it acquired from Intelligent Bio-Systems last year (IS 6/26/2012), a startup that had been developing an NGS platform with sequencing technology developed by Jingyue Ju at Columbia University.

At this year's Advances in Genome Biology and Technology conference in Marco Island, Fla., the firm elaborated on its next-gen sequencing workflow, including the development of two new platforms — the QiaCube NGS for automated library preparation and the GeneReader for sequencing (IS 2/26/2013).

Additionally, as part of Qiagen's initiative to provide a complete end-to-end workflow, this week it acquired bioinformatics firm CLC Bio. "The addition of CLC Bio means that we have now brought together the key core elements needed for our NGS program, enabling Qiagen to offer a complete solution from biological sample through to valuable molecular insight," Schatz said during the conference call.

By focusing on the entire sequencing workflow from sample prep through analysis, Qiagen is aiming to target the clinical research and diagnostics market.

Its initial forays into the clinical sequencing market were a series of cancer gene panels that it launched last year (CSN 11/7/2012).

Schatz said that Qiagen would have 20 gene panels by the end of this year, all of which would be linked to the company's Ingenuity Variant Analysis platform for interpretation.

He added that CLC Bio's algorithms for analysis would also be linked to the assays, and complement Ingenuity's interpretation.

Qiagen also has a number of PCR-based tests, such as BRAF and EGFR assays. Moving forward, Schatz said that Qiagen would continue to offer PCR-based tests, and that in some cases the next-gen sequencing panels would serve as "reflex tests."

"Having the availability of both PCR and NGS under one roof gives us an enormous differentiator in the clinical market because we are objective and will provide what's clinically and economically the best solution," he said.

Additionally, because the focus of Qiagen's next-gen sequencing workflow is the clinical market, Schatz said that he expects CE marking and US Food and Drug Administration clearance would follow close behind the launch.

"We've been developing this workflow with clinical research and diagnostics customers as our top priority," he said.

"The solution we are bringing to market [will] have a CE and also an [in vitro diagnostic] track. And, we have been very diligent in making sure that everything we do allows us to move in that direction very swiftly. We're not talking years after launch, but near term."

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