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Qiagen Expands HLA Test Development Pact with Genome Diagnostics

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Qiagen today said that it has expanded a partnership with Dutch molecular diagnostics firm Genome Diagnostics to develop and commercialize six new tests.

The agreement runs through 2011 and expands on an alliance between the firms that began in 2006.

Under the pact, Genome Diagnostics will develop tests that target genetic variations in the Human Leukocyte Antigen complex. The tests will be based on Qiagen's pyrosequencing and other sequencing technologies, which will enable "fast, cost-effective and accurate analysis of HLA sequences, thereby allowing for direct detection of previously unknown polymorphisms," Qiagen said in a statement.

"Sequence-based HLA typing is a fast growing market with significant potential," Bob Barrett, Qiagen's VP of global marketing, molecular diagnostics, said. "Since HLA genes are increasingly associated with a growing number of diseases and the patients' response to drugs, HLA testing allows for the assessment of disease risks and for the development of tailored treatments."

Qiagen believes the tests will be sold for both prevention and personalized healthcare applications. For example, among the tests will be one for the biomarker HLA DQA1 gene, which is associated with a higher risk for adverse reactions to Novartis' osteoporosis drug lumiracoxib (Prexige).

That drug was withdrawn from Canadian, European, and Asian markets after the occurrence of adverse reactions linked to its potential toxic effect on the liver, Qiagen noted. In early 2010, Novartis said it may re-submit lumiracoxib for regulatory approval in combination with an unidentified companion diagnostic that would identify patients not at risk to develop such adverse reactions based on their genetic profile.

Qiagen already has a portfolio of molecular assays for HLA typing, including a test for the biomarker HLA B*5701, which has been associated with a higher risk for adverse reactions to the AIDS drug abacavir (Ziagen).

A year ago, Qiagen sold part of its HLA testing portfolio for transplant applications to LinkMed, but it retained certain rights to sell those products for personalized healthcare. At the time, Qiagen CEO Peer Schatz said that the deal would enable Qiagen to streamline its portfolio.

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