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Qiagen Gets China OK for New HPV Test

NEW YORK (GenomeWeb News) – Qiagen announced after the close of the market Wednesday that it has received China State Food and Drug Administration approval for its careHPV Test and instrument platform.

Qiagen said that the careHPV test is the first molecular diagnostic to screen for high-risk human papillomavirus designed specifically for low-resource clinical settings, such as those lacking electricity, water, or modern laboratory infrastructure. The test is based on the digene Hybrid Capture technology and was developed in collaboration with PATH, an international nonprofit organization.

Among the features of the test system are color-coded, easy to understand menus, contained reagents, and an ability to tolerate temperature variations occurring in rural clinics lacking refrigeration for sample storage.

Qiagen said that it intends to launch the careHPV test in China in January 2013, followed by India later in the year and in other emerging markets as approvals are received. The test is manufactured by Qiagen at its facilities in Shenzhen.

"We are expanding Qiagen's prevention portfolio by launching the careHPV system in emerging markets, both through a commercial offering to healthcare providers and through donations to governments and NGOs that are in the process of implementing large scale cervical cancer prevention plans," Helge Lubenow, SVP of Qiagen's Molecular Diagnostics Business Area, said in a statement. "This new product complements our well-established global leadership with the digene HC2 HPV test and can also be used very synergistically for example to allow national or regional screening programs to cover the infrastructure profiles of all segments within the targeted region."

The careHPV test was part of an alliance announced earlier this year with Merck to provide cervical cancer screening and HPV vaccination in Rwanda.

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