QIAGEN has announced that it has entered into an agreement with the Dutch molecular diagnostic component supplier Genome Diagnostics which covers the development and commercialization of 6 new tests until 2011.

QIAGEN believes that this collaboration will further expand the Company’s testing portfolio for the early detection of diseases and individualized treatment of patients—thereby strengthening QIAGEN’s molecular diagnostics offering for applications in prevention and personalized healthcare. Financial details have not been disclosed.

The molecular tests to be developed by Genome Diagnostics target the detection of genetic variations in the so called Human Leukocyte Antigen (HLA) complex. These assays represent the next generation of such tests and are based on QIAGEN’s proprietary "Pyrosequencing" and other sequencing technologies. In contrast to other detection methods, Pyrosequencing enables fast, cost effective and accurate analysis of HLA sequences, thereby allowing for direct detection of previously unknown polymorphisms.

Main application areas for the new tests will include prevention and personalized healthcare. These are areas where HLA testing is considered to be increasingly important. Among others, the new product portfolio will include tests for the biomarker HLA DQA1 gene, which is associated with a higher risk for adverse reactions to lumiracoxib, a painkiller marketed by Novartis under the trade name Prexige for treatment of the bone disease Osteoporosis.

Lumiracoxib was withdrawn from Canadian, European, and Asian markets after the occurrence of adverse reactions linked to its potential toxic effect on the liver. In early 2010, Novartis announced a possible re-submission of the drug for regulatory approval in combination with an unidentified companion diagnostic which would allow the identification of patients not at risk to develop such adverse reactions, as indicated by their genetic profile. This would make lumiracoxib the first drug which was withdrawn from the market but then re-approved by regulatory authorities in combination with a companion diagnostic test.

Other biomarkers targeted by the new tests include the identification of alleles (DNA sequences of a particular gene) within the groups HLA-B*27 and HLA-B*57. The analysis of these genetic variations in the HLA complex allows for the early identification of patients who are at risk of developing disorders such as Morbus Bechterew and other inflammatory diseases, and is thus considered to be an important part in preventing these disorders. It has also been shown that certain alleles within the groups of HLA-B*27 and HLA-B*57 can give information on the development and progress of infectious diseases such as AIDS.

QIAGEN’s portfolio already includes several molecular tests for the DNA-based HLA typing in personalized healthcare, among others a method for the detection of the HLA B*5701 biomarker. This genetic variation is associated with a higher risk for adverse reactions to the AIDS drug Abacavir.

In June 2009, QIAGEN announced that it sold parts of its HLA test portfolio for use in transplantation testing to the Swedish investment company LinkMed and retained rights to market those products in areas such as personalized healthcare. QIAGEN and Genome Diagnostics have been working together since August 2006 on the development and commercialization of new product lines in HLA testing. This collaboration is now being expanded through the development of additional tests.

"Sequence based HLA typing is a fast growing market with significant potential," commented Bob Barrett, VP Global Marketing, Molecular Diagnostics at QIAGEN. "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. That’s why the tests we develop as a result of this collaboration make a perfect addition to our molecular diagnostics portfolio for applications in prevention and personalized health care."

"We are excited to further strengthen our collaboration with QIAGEN," said Wietse Mulder, Managing Director of Genome Diagnostics. "This allows us to expand our unique expertise in sequencing based HLA typing into the field of companion diagnostics, leading to new innovative IVD assays for the field of preventive and personalized health care."

Source: QIAGEN