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Qiagen Jumps into Personalized Medicine with Purchase of Companion Diagnostic Firm DxS

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By Turna Ray

Qiagen, one of the largest providers of sample and assay technologies for molecular diagnostics firms, threw its hat in the personalized medicine arena this week with the purchase of UK-based DxS.

Under the terms of the acquisition, Qiagen will pay approximately $95 million in cash, plus up to an additional $35 million if certain undisclosed commercial and other milestones are met.

"With this acquisition, Qiagen has taken a strong leadership position in the new era of personalized healthcare," the company said in a statement.

Qiagen said that it expects the acquisition to contribute approximately $6 million in sales for the rest of 2009 and approximately $30 million in 2010. Qiagen's full-year 2008 revenues were $893 million.

Between them, Qiagen and DxS are currently involved in 15 collaborations with pharmaceutical partners for the development or marketing of companion diagnostics to personalize marketed or investigational drugs. "The programs span genetic, expression, epigenetic and other markers," Qiagen said.

Earlier this month, DxS inked a deal with Bristol-Myers Squibb/ImClone Systems to develop a companion diagnostic test kit for the colorectal cancer drug Erbitux. DxS has a similar deal to develop a companion diagnostic for Amgen's colorectal cancer drug Vectibix. The companion tests detecting KRAS mutations will be based on DxS' RT-PCR-based TheraScreen platform [see PGx Reporter 09-02-2009].

DxS' TheraScreen: KRAS Mutation Test kit is CE-marked in Europe, and is currently undergoing pre-market approval at the US Food and Drug Administration [see PGx Reporter 03-04-2009]. Qiagen estimates the future market for overall KRAS testing to be as much as $100 million.

In addition to Amgen and BMS/ImClone, DxS has inked two separate agreements to commercialize its TheraScreen EGFR 29-Mutation test kit as companion diagnostics for Boehringer Ingelheim's investigational NSCLC drug BIBW2992 and AstraZeneca's NSCLC drug Iressa. The company also has a worldwide distribution deal with Roche Diagnostics for its TheraScreen KRAS test and TheraScreen EGFR 29-Mutation test [see PGx Reporter 06-04-2008].

Qiagen also said that DxS has three molecular diagnostic tests in the "near-term pipeline" and additional assays in a longer-term pipeline.

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Specifically, Qiagen said that DxS' portfolio of real time PCR-based companion diagnostics for targeted cancer drugs complements Qiagen's assay and sample technologies, particularly its QIAsymphony sample-prep platform and its Rotor-Gene Q thermal cycler. In addition, Qiagen's portfolio includes pyrosequencing-based KRAS, BRAF, and methylation assays targeting biomarkers, as well as gene expression and miRNA assays for biomarker discovery.

In acquiring DxS, Qiagen is attempting to increase its presence in molecular diagnostic-based prevention, disease profiling, and personalized healthcare. Meantime, coming under the Qiagen umbrella is likely to provide a relatively small personalized medicine firm like DxS a global reach and even more negotiating clout with large pharma and biotechs.

"Unlike any other company, we believe that Qiagen addresses the broadest range of companion diagnostic options for pharmaceutical and large biotech companies — starting from an independent sales reach over broad technology, R&D, and manufacturing capabilities up to expertise in regulatory affairs and access creation to physicians and laboratories," DxS CEO Stephen Little said in a statement.

With a focus on inking Rx/Dx deals with pharma, Qiagen is planning to establish DxS' headquarters in Manchester, UK, as a Center of Excellence in Pharma Partnering.

DxS's distribution deal with Roche was surely a plus when inking deals for its KRAS companion test for Amgen's and BMS' colorectal cancer drugs. Similarly, already having Rx/Dx collaborations with large pharma likely made the smaller firm ripe for acquisition.

Monogram, which has a development and commercialization deal with Pfizer for a test accompanying the HIV drug Selzentry, was acquired by Laboratory Corporation of America earlier this year [see PGx Reporter 08-05-2009]. LabCorp has said it is increasing its focus on personalized medicine, particularly on developing companion diagnostics.

While pharmaceutical firms work with smaller diagnostics firms on occasion, it is advantageous for diagnostic partners to be able to meet their multi-national partners' needs in terms of global manufacturing and marketing capabilities, regulatory experience in the US and abroad, and a track record with payors.

Looking for these very same capabilities, Pfizer announced a deal with Abbott Molecular Diagnostics to develop a companion test for an investigational lung cancer drug. However, despite going with a large biotech firm in this one instance, Hakan Sakul, Pfizer's head of diagnostics, has urged small Dx firms to continue to bring Pfizer its proposals [see PGx Reporter 09-09-2009].

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