The China's State Food and Drug Administration (SFDA) has granted approval to QIAGEN's molecular diagnostic assay, designed for screening high risk human papillomavirus (HPV) in low-resource clinical settings.
The portable careHPV test, which is developed in collaboration with PATH, utilizes Hybrid Capture technology to screen women living in low-resource areas lacking electricity, water and modern laboratory infrastructure.
The assay, in addition to instrument and collection devices, 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.
Clinical studies, which were performed in China, Nigeria, Rwanda and Thailand in parallel with PATH demonstration trials in China, India, Uganda and Nicaragua, have shown that careHPV test provides high sensitivity and reliability in low-resource settings.
QIAGEN molecular diagnostics business area senior vice president Helge Lubenow said about 275,000 women a year die from cervical cancer, more than 85% in less-developed countries.
"As the only test of its kind, careHPV offers the life-saving benefits of sensitive molecular diagnostics to resource-poor regions," Lubenow added.
"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.
"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 company said the careHPV assay is expected to be available in China in January 2013, followed by India later in 2013 and other emerging markets as approvals are received.