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Qiagen, Abbott Enter into Molecular Dx Pact

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Qiagen and Abbott late on Tuesday announced a broad molecular diagnostics agreement covering HIV, human papillomavirus, and hepatitis C.

Under the terms of the deal, Qiagen will receive kits from Abbott for a PCR-based molecular assay for HIV-1 viral load testing in the US and Canada. In return, it will provide Abbott certain key products needed for a PCR-based HPV test in the US and Canada.

In addition, Abbott will provide a quantitative hepatitis C test, which will be optimized and labeled for use on Qiagen's QIAsymphony RGQ instrument and marketed under the Abbott name in the US and Canada. Subject to regulatory approval the HCV test may become available by the end of 2012, the two firms said in a joint statement.

Financial terms of the deal were not disclosed.

Qiagen expects its HIV-1 test, which will be sold under the Qiagen name, to become available in 2012.

Abbott will develop the HPV test on its m2000 system. Qiagen will continue to address the HPV market through its prevention platform QIAensemble. Technologies which form the basis for Qiagen's current and next-generation HPV screening tests are not covered by Tuesday's agreement.

The two firms said that HIV, with sales of $180 million in the US annually, and HCV with annual sales of $140 million in the US, are among the most widely used commercial applications in molecular diagnostics. They added that the agreement announced today "significantly" strengthens the value of their respective automation platforms "and will reinforce their leadership in infectious disease testing."

According to Qiagen CEO Peer Schatz, the deal could "significantly accelerate our dissemination strategy for the QIAsymphony RGQ" — which was launched last month and is labeled for clinical use in Europe — "by expanding our molecular diagnostic menu offering in the United States with important testing options."

In addition, Qiagen now will be able to commercialize previously unused IP around a PCR design for HPV assays, he said.

The HIV test, Qiagen said, adds to the company's pipeline of regulatory submissions, which is expected to include a quantitative hepatitis B assay. It has FDA-approved tests for HPV, and Chlamydia, and CE-marked tests for HIV, HCV, HBV, and other ailments.

It added that it has a "broad pipeline" of assays for its QIAsymphony and QIAensemble platforms for launch in the US, Europe, and elsewhere in 2011 through 2013.

Tests approved for sale in the US on the Abbott m2000 system include assays for HIV, HBV, chlamydia, and gonorrhea. The company offers tests outside the US for HIV viral load, HBV and HCV viral load, hepatitis C genotyping, and other diseases.

In trading early Wednesday morning, shares of Qiagen rose about 5 percent.

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