Companies together have over 15 partnerships, all related to anticancer agents.

Qiagen has picked up DxS for about $95 million in cash plus up to $35 million if certain commercial and other milestones are met. The deal significantly pads Qiagen’s molecular diagnostic offerings with companion diagnostic tests already on the market and in development

Based in Manchester, U.K., DxS develops and manufactures companion diagnostic products and has been on a deal-making rampage this year.  The company signed an agreement with AstraZeneca to use its TheraScreen®: EGFR29 Mutation Kit® as a companion diagnostic to Iressa, a non-small-cell lung cancer (NSCLC) treatment. The EGFR29 Mutation Kit is also being leveraged by Boehringer Ingelheim along with its tyrosine kinase inhibitor, BIBW 2992, which is in Phase III trials for NSCLC. Additionally, DxS is working with ImClone Systems and Bristol-Myers Squibb on the development of a companion diagnostic for Erbitux® based on its TheraScreen K-RAS Mutation Kit.
Qiagen and DxS together reportedly have over 15 collaborations to market and/or develop diagnostic tests for oncology drugs. The programs span genetic expression as well as epigenetic and other markers.

DxS’ currently marketed portfolio includes seven real-time PCR tests. The TheraScreen: K-RAS Mutation Kit developed by DxS has already been CE-marked. The company plans to submit it for regulatory approval in the U.S. next year. Additionally, three assays are in the near-term pipeline. All DxS’ assays are strongly suitable for use with Qiagen’s existing suite of platform instruments including QIAsymphony and Rotor-Gene Q.

“Qiagen is the ideal partner for DxS to globally roll out our assays, to take our partnerships to the next level, and to take a leadership position in companion diagnostics,” says Stephen Little, founder and CEO of DxS. “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.”

Qiagen expects this transaction to contribute approximately $6 million in sales for the rest of 2009 and roughly $30 million in 2010. The acquisition will likely be neutral to EPS this year and be dilutive by $ 0.02 in 2010. Beyond 2010, it is expected that the takeover will be accretive to adjusted EPS.

Qiagen’s own portfolio includes pyrosequencing-based K-RAS, BRAF, and methylation assays targeting biomarkers as well as large numbers of gene-expression and miRNA assays for discovery of future markers and instrument platforms to automate these tests.

Qiagen’s laboratory-based molecular diagnostics are divided into three segments: prevention, profiling, and personalized healthcare. The prevention division covers markers tested in asymptomatic patients for the purpose of early disease or risk detection. It currently has HPV tests and is developing a panel of assays including tests for chlamydia and gonorrhea. This platform is expected to launch in late 2010 in Europe and in mid 2012 in the U.S.

The profiling segment covers tests performed on symptomatic patients to create or confirm a diagnosis. Qiagen reports that it currently has over 80 such assays. The personalized healthcare segment includes assays that are used to guide therapy for prediagnosed symptomatic patients. The company says that it currently sells about 20 assays in personalized healthcare.

Separately, Qiagen and Merck & Co. have agreed to work together to increase access to the former’s digene HPV Test and a new DNA test that is currently in development along with the latter’s HPV vaccination, Gardasil. The companies will be reaching out to select countries under The Global Alliance for Vaccines and Immunisation. Merck will provide for free up to five million doses, and Qiagen intends to add to its existing one million test donation program by offering tests to screen an additional 500,000 women.

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