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Revising Molecular Dx Roadmap, Qiagen Will Migrate PCR Tests Across Automated Platforms

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Updating the development roadmap for its automated molecular diagnostic platforms, Qiagen said last week that it will link its QIAsymphony and QIAensemble systems so that PCR-based tests and hybrid-capture tests can be migrated across the two platforms.

Following a review of the development strategy for its high-throughput QIAensemble platform, the company has decided that its next-generation QIAensemble Revolution system will run PCR-based tests and hybrid-capture tests. Previous plans called for the platform to run hybrid-capture assays and tests based on isothermal amplification detection technology that it had licensed from Biohelix in 2008

The first assay to be affected by this plan is a test for chlamydia and gonorrhea that the company was previously developing for the isothermal amplification technology but will now be based on real-time PCR. The test will initially be launched on the company's QIAsymphony, which is integrated with the Rotor-Gene Q real-time PCR cycler, and will then be migrated to the QIAensemble platform.

Qiagen said it expects to submit the new CT/NG assay in 2012 for regulatory approval in Europe and "shortly thereafter" in the US.

A Qiagen spokesperson said that the PCR-based test has been prioritized over the isothermal test because "we decided to link the QIAensemble program with the QIAsymphony program" following a "comprehensive review" of the development roadmap.

"The capability to migrate tests across platforms is a key element in the updated QIAensemble strategy, as it allows us to accelerate menu creation and thereby expand our leadership position in molecular diagnostics," said the spokesperson.

As part of this integrated strategy, the company plans to add "proven technologies" from the QIAsymphony instrumentation family into the QIAensemble ST, or “sample technology,” system. Qiagen plans to offer three sample-processing configurations under this model: QIAsymphony for low-to-medium-throughput (up to 300 samples per shift); QIAensemble ST for "significantly higher" volumes; and custom configurations of QIAensemble system modules for customers who require throughput of "far more" than 1,000 samples per shift.

"By building upon proven core components from the QIAsymphony platform, Qiagen will enhance compatibility of QIAensemble and QIAsymphony, allowing the migration of tests within and between the platforms," the company said in a statement. "This design feature also will enable customers to consolidate workflows on a standardized system supporting multiple detection technologies, including real-time PCR and hybrid capture."

A first version of the QIAensemble platform, called QIAensemble Evolution, will be launched later this year in Europe, with a US launch planned for 2012. That system will include a decapper unit for automatically unsealing liquid cytology sample vials as well as several sample-prep solutions based on technology in the existing QIAsymphony platform. The company's Rapid Capture System — the technology that underlies its Digene human papillomavirus test — will still serve as "an integral component" of the QIAensemble program.

The next-generation QIAensemble Revolution, meantime, will support both hybrid capture and real-time PCR. In addition to the decapper unit and QIAsymphony sample-prep technologies, the Revolution system will include a new assay processing system called the QIAensemble AT that is expected to "more than double" the capacity of the current Rapid Capture System.

Qiagen said that it will migrate its Digene HC2 HPV test to the first version of this system and is also developing a next-generation HPV assay "with a focus on disease progression and other markers that could be included in a future clinical trial of such a new testing panel."

Qiagen said it expects QIAensemble AT to receive a CE-IVD mark in Europe in 2012 and is planning a submission for US approval in 2013.

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