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A blossoming diagnostic duo
November 2009
by David Hutton  |  Email the author


VENLO, The Netherlands—Qiagen N.V. has acquired DxS Ltd., a privately held developer and manufacturer of companion diagnostic products headquartered in Manchester, U.K., in a deal valued at $95 million, plus up to an additional $35 million if specified commercial and other milestones are met.
DxS makes genetic testing kits to determine which patients are most likely to benefit from certain cancer treatments.
Qiagen, which makes a testing kit for swine flu, says DxS's assets complement its "existing strong portfolio of personalized healthcare diagnostic solutions."  
Qiagen also says the combined company is currently active in more than 15 collaborations with pharmaceutical companies to market and/or develop companion diagnostic products.
The programs span genetic, expression, epigenetic and other markers. Qiagen believes that this pipeline is the deepest such portfolio in the pivotal field of molecular diagnostics for personalized healthcare.   The acquisition of DxS brings to Qiagen a portfolio of molecular diagnostic assays and intellectual property, as well as a deep pipeline of active or planned companion diagnostic partnerships in oncology with many of the leading pharmaceutical companies, including seven of the largest drugmakers in this field.
According to Peer Schatz, Qiagen's CEO, the company sells its sample and assay technologies in four markets—molecular diagnostics, academic research, the pharmaceutical industry and applied testing.
"In molecular diagnostics, we've defined three different segments where we execute a strategy to attain and expand a leadership position," he notes. "These segments are prevention, profiling and personalized healthcare. According to industry reports, the market for personalized healthcare has seen a compound annual growth rate of 24 percent over the last decade, amounting to $13 billion in 2008. It is estimated that the segment for overall K-RAS testing alone could reach up to $100 million—and we have 18 products, several of which are currently in the pipeline targeted for FDA submissions and CE marking."  
Qiagen isn't a newcomer to the field. Prior to the transaction, the company was marketing a broad portfolio of sample and assay technologies for personalized healthcare.
"Our offering included 11 personalized healthcare tests, including Pyrosequencing-based assays for K-RAS and BRAF, a test for a gene variation associated with adverse hypersensitivity reactions to the HIV drug Abacavir, methylation assays for various cancer biomarkers and a broad range of assays for the discovery of future biomarkers along with the corresponding instrumentation platforms," adds Schatz. "The acquisition helps us to further expand this offering, and positions Qiagen as the leading independent supplier of companion diagnostics products."
After the deal, the combined company will market a portfolio of 18 assays for personalized healthcare—thereby leading in K-RAS testing as the first blockbuster segment, with additional assays in the near- and medium-term pipeline and boasting more than 15 partnerships with pharmaceutical companies.  
"In K-RAS testing, the DxS assay uses the well established PCR technology in an assay format which is the option of choice for companion use with several major drugs," Schatz says. "It is therefore the first option for labs which detect clinically relevant mutations. It has been significantly validated with, and is an integral part of, the clinical trials of several drugs already in the market. Qiagen's Pyrosequencing based test detects both known and unknown mutations and thus offers a more complete picture, being a second option for these labs. This becomes relevant for instance for future research purposes or for new clinically relevant targets. Also, DxS' portfolio and pipeline of assays is strongly suitable for use with Qiagen's existing suite of instruments, including QIAsymphony and Rotor-Gene Q."  
DxS was founded in 2001 by CEO Steve Little and co-director David Whitcombe. The company has developed a set of molecular diagnostic assays that allow physicians in oncology to predict patients' responses to certain treatments in order to make cancer therapies more effective and safer.
The currently marketed portfolio spans seven real-time PCR tests including a test for the mutation status of the oncogene K-RAS, which is indicative for successful treatment of patients suffering from metastatic colorectal cancer (mCRC) with EGFR inhibitors. In addition, three assays are in the near-term pipeline and further assays are in the medium-term pipeline.   DxS' portfolio of assays, both marketed and in its pipeline, is strongly suitable for use with Qiagen's existing suite of platform instruments, including QIAsymphony and Rotor-Gene Q, Little says.  
"Qiagen is the ideal partner for DxS to roll out our assays globally, to take our partnerships to the next level and to take a leadership position in companion diagnostics," says Steve Little, founder and CEO of DxS.   Following closing of the transaction, DxS will be renamed Qiagen Manchester Ltd. Senior management at DxS will join Qiagen in leading roles in the rapidly expanding personalized healthcare focus area, facilitating rapid integration and focus on the further expansion of this key segment. For that purpose, Qiagen intends to establish a headquarters for DxS in Manchester as a Center of Excellence in pharma partnering. According to Schatz, the combination has the potential to create a classic"win-win situation for everyone involved."
"Overall, our goal is to further deepen the existing partnerships and establish new collaborations with pharmaceutical companies, and to drive the future development of personalized healthcare applications to create a win-win situation for all stakeholders involved," Schatz concludes.
Code: E110906



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