SFDA Approves careHPV Test
Qiagen N.V. announces that China’s State Food and Drug Administration (SFDA) has approved the company’s careHPV Test and instrument platform. The careHPV Test is the first molecular diagnostic to screen for high risk human papillomavirus designed for low-resource clinical settings, such as areas lacking electricity, water, or modern laboratory infrastructure.
The product availability of careHPV in China is expected to be announced 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 conference 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 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 menus, contained reagents, and tolerates temperature variations that occur in rural clinics lacking refrigeration for sample storage. 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.
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.
Release Date: Nov. 28, 2012