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Biomarker Deal with Alacris Boosts Qiagen's Rx/Dx Capabilities

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By Turna Ray

By gaining access to all biomarkers in Alacris Theranostics' portfolio, Qiagen is hoping to develop new cancer diagnostics for commercial and research purposes, expand its presence in the companion diagnostics space, and license biomarkers to other firms.

This week, Qiagen announced it would acquire a minority stake in Alacris, which uses whole-genome sequence analysis to develop individualized cancer therapies. "Our strategic investment in Alacris expands Qiagen's existing broad biomarker discovery and validation initiatives and is designed to expand our QIAsymphony-based personalized healthcare and pharma development assay portfolio," Peer Schatz, Qiagen CEO, said in a statement announcing the deal.

Under the terms of the agreement, Qiagen has an exclusive option to all of Alacris' discovered biomarkers. Alacris will receive royalties from the commercialization of its biomarkers.

The specific financial terms of the acquisition were not disclosed.

"The deal is not limited to specific biomarkers, but given Alacris' current focus we expect biomarkers associated with cancer will play a more prominent role," Thomas Theuringer, Qiagen's director of public relations, told PGx Reporter this week.

By acquiring a stake in Alarcris, Qiagen will also benefit from the company's biomarker discovery platform, ModCell. This bioinformatics system stands to help Qiagen sift through tomes of data from sequencing and other technologies and identify relevant clusters of biomarkers. These marker subsets can then be used to stratify patients in clinical trials. Validated biomarker sets can eventually be incorporated into new real-time PCR-based tests.

The ModCell system "correlates massive amounts of data with other biomedical information to make predictions on a patient's responses to certain treatments and drugs," Theuringer explained. He added that ModCell can work with data from any sequencing platform, and can also analyze transcriptomic, epigenomic, or proteomic information for biomarker discovery.

"Alacris, not Qiagen, will use the system to stratify patients for clinical studies," Theuringer said.

Access to validated biomarkers will certainly help Qiagen add to its test offerings, and help attract pharma partners for drug/diagnostic codevelopment deals.

Qiagen currently markets its TheraScreen line of RT-PCR-based pharmacogenetic cancer tests that can help doctors determine which patients will respond to oncologics such as Iressa (AstraZeneca), Vetibix (Amgen), and Erbitux (Merck/Lilly/Brsitol-Myers Squibb). The company has announced Rx/Dx deals with the sponsors of these drugs, and has noted it holds similar collaborations with several unannounced pharma partners.

Biomarkers identified by Alacris can "contribute to the discovery and validation engines of biomedical and pharma companies, which again may lead to collaborations around these engines to create fast-track approvals to new diagnostic content, most notably in personalized healthcare," Theuringer said. "And, of course, access to the technology can facilitate clinical trials by helping pharma companies to speed up their drug discovery and development programs by allowing them to stratify certain patient populations based on the identified biomarkers."

Although ModCell may not accelerate clinical trials for investigating Qiagen's assays, Alacris' data-mining capabilities could "significantly shorten" the process of identifying and validating biomarkers, Theuringer added.

Qiagen said it is currently involved in more than 20 projects with eight of the top 10 pharmaceutical companies to develop companion diagnostics based on molecular biomarkers. Additionally, with its acquisition of SABiosciences in 2009, Qiagen has also been able to ink several partnerships for the discovery and validation of biomarkers, which could lead to the development of new tests and treatments.

The deal with Alarcris opens up several options for Qiagen in terms of forming biomarker-based partnerships. "We can develop new molecular diagnostic assays as part of our TheraScreen portfolio of personalized healthcare tests. We can also develop and commercialize PCR assay panels for biomedical research and drug development," Theuringer said. "And of course we can license biomarkers to third parties."

Although the biomarkers accessed through Alacris will have an immediate application focus in oncology, which matches Qiagen's current product portfolio, the company may expand into other disease areas. In the future, "we may also see partnerships for development of companion diagnostics for drugs targeting autoimmune, cardiovascular, and other diseases," Theuringer said.


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