Qiagen N.V. announced that China’s State Food and Drug Administration (SFDA) has approved the company's careHPV Test and instrument platform. The 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 availability of careHPV in China in January 2013, followed by India later in 2013 and other emerging markets as approvals are received. The company will introduce the careHPV Test and key data of its performance at the International Papillomavirus conference, starting November 30 in Puerto Rico.
Qiagen developed the careHPV Test in collaboration with PATH, an international nonprofit organization, to expand access to HPV screening in low-resource settings. The robust, portable, easy-to-use careHPV assay, instrument, and collection devices are designed for areas with limited infrastructure and can provide results during the patient visit. The system has color-coded, easy-to-understand menus, contained reagents, and tolerates temperature variations that occur in rural clinics lacking refrigeration for sample storage due to limited electricity or water. Non-medical staff can be trained in hours to use the careHPV system, and the test also has been shown to avoid cross-contamination of samples even in the most stringent settings.
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.