QIAGEN N.V. today announced that China’s State Food and Drug Administration (SFDA) has approved QIAGEN’s careHPV Test and instrument platform. The careHPV Test is the first molecular diagnostic to screen for high risk human papillomavirus (HPV) designed for low-resource clinical settings, such as areas lacking electricity, water or modern laboratory infrastructure. QIAGEN expects to announce the product availability of careHPV in China in January 2013, followed by India later in 2013 and other emerging markets as approvals are received. QIAGEN will introduce the careHPV Test and key data of its performance at the International Papillomavirus (IPV) conference, starting November 30 in Puerto Rico.

QIAGEN is the global market leader in HPV testing with its “gold standard” digene HC2 HPV Test, the most validated and sensitive diagnostic for detection of high-risk HPV – a primary cause of cervical cancer. It is the only assay that has demonstrated its effectiveness in close to 1 million women in clinical, randomized and independent studies. The digene HC2 test, compatible with modern laboratories and automated processing, is widely used in developed countries and large cities in emerging markets, including China. The digene HC2 test has protected more than 100 million women so far and remains QIAGEN’s core product for cervical cancer prevention. The careHPV and digene HC2 tests are both based on clinically proven Hybrid Capture technology, and are highly complementary because they serve different laboratory needs.