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Qiagen Plans to Launch First NGS Products in 2013; Technology will Complement RT-PCR, Pyrosequencing

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Qiagen plans to release its first next-generation sequencing products next year as part of its initiative to "expand the use of NGS into clinical research and molecular diagnostics," according to a company executive.

In June, the company revealed an ongoing initiative to build a clinically focused next-gen sequencing workflow. As part of that, Qiagen acquired Intelligent Bio-Systems, which had been developing next-gen sequencing platforms based on sequencing-by-synthesis chemistry licensed from Columbia University, and partnered with business software firm SAP on data processing and bioinformatics (CSN 6/27/2012).

In a conference call to discuss Qiagen's second-quarter earnings last week, CEO Peer Schatz explained that the company's next-gen sequencing products will not address the target discovery market, which he said is "by far" the largest market for NGS today. "Instead, we want to capture rapidly emerging opportunities in select areas, particularly by bringing this technology into clinical research and molecular diagnostics."

He said that customers have been telling Qiagen that the currently available NGS platforms do not meet their needs. In particular, those customers are looking for less expensive, more efficient, and routine workflows that are "based on proven standards," he said. They also want to be able to process multiple samples and load them continuously, and to analyze individual samples for specific targets, "which means random access." In addition, customers are interested in a full workflow, from sample prep to data interpretation, as well as a broad portfolio of assays.

"Our aim is to address all of these needs by offering complete workflow solutions based on proven Qiagen technologies, in combination with contributions from a range of partners," including SAP and newly acquired IBS, Schatz said.

"We are also open to working with other players to leverage our content strength as well," he noted. The company's GeneGlobe web portal already offers a portfolio of more than 60,000 well-defined molecular assays, which Qiagen now plans to use also for NGS applications.

Qiagen's own NGS system, more detailed specifications of which the company plans to reveal early next year, "will aggregate components, chemistries, and other elements from several sources and, therefore, will boast specifications beyond what has been previously disclosed from any contributed element," Schatz said.

He said that next-gen sequencing will not replace the company's real-time PCR or pyrosequencing technologies but will be complementary to those. "We see NGS being adopted in areas such as exploratory diagnostics, the diagnosis of complex diseases, and treatment of cancer patients."

More specifically, Qiagen's NGS workflow will include the company's existing sample prep technologies, such as nucleic acid extraction, nucleic acid preprocessing, and target enrichment products. It will also make use of Qiagen's QIAsymphony and QIAcube automation platforms.

The new sequencer module will build on IBS' sequencing-by-synthesis technology "and the benefits of Qiagen's chemistry," as well as "unique instrument concepts" from IBS, such as the ability to process up to 20 individual samples in parallel and to load flow cells continuously while the instrument is operating.

New software developed with SAP, using that firm's Hana technology, will significantly reduce data processing time and "better handle the processing of large amounts of data," he said.

Schatz reiterated that the firm will start with eight preconfigured gene panels for cancer, as well as customized panels.

Qiagen will face formidable competition in its effort to introduce next-gen sequencing in the clinical market, mostly from Illumina and Life Technologies, which are pushing their MiSeq and Ion Torrent PGM platforms into clinical applications and are planning to submit these instruments for 510(k) clearance by the FDA before the end of this year.

The company is also in litigation with Illumina over patents relating to the sequencing technology it acquired from IBS (CSN 7/23/2012).

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