China's SFDA has approved QIAGEN's careHPV test and instrument platform. The careHPV test is believed to be 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.
The careHPV test is manufactured by QIAGEN in Shenzhen, China, making the "country of origin" approval a critical milestone. Many countries are able to use this approval by the SFDA for their own regulatory approval, instead of conducting lengthy and costly local regulatory submissions. The careHPV rollout will target areas in Asia, Latin America, Eastern Europe and Africa.
Clinical studies with the careHPV test have been conducted in China, Nigeria, Rwanda and Thailand in parallel with PATH demonstration trials in China, India, Uganda and Nicaragua. The data demonstrate the high sensitivity and reliability of the careHPV Test in low-resource settings.