Qiagen’s careHPV Test and instrument platform has been approved by China’s State Food and Drug Administration (SFDA). According to the company, the careHPV Test is the first molecular diagnostic to screen for HPV that has been designed for low-resource clinical settings, including areas lacking electricity, water, or modern laboratory infrastructure.
Qiagen expects that careHPV will be available in China in January 2013, followed by India later in 2013 and other emerging markets as approvals are received.
The careHPV test is based on Qiagen’s Hybrid Capture technology, as is the firm’s core product for cervical cancer prevention, digene HC2 HPV Test, which is used in developed countries and large cities in emerging markets, including China.
Qiagen developed the careHPV Test in collaboration with PATH, an international nonprofit organization, to expand access to HPV screening in low-resource settings. care HPV is reportedly robust, portable, and easy-to-use.
“As the only test of its kind, careHPV offers the life-saving benefits of sensitive molecular diagnostics to resource-poor regions. About 275,000 women a year die from cervical cancer, more than 85 percent in less-developed countries. We have teamed with PATH to create careHPV as part of a preventive strategy that will save many women’s lives,” said Helge Lubenow, Ph.D., senior vp, molecular diagnostics business area.
In September, Qiagen inked an agreement with Lepu Medical Technology to provide its ESEQuant Lateral Flow System for use in emergency rooms with Lepu’s tests for cardiac markers that diagnose acute myocardial infarction. The agreement expanded Qiagen’s presence in China and added a new point of need diagnostics application.
Earlier in 2012 Qiagen acquired the AmniSure immunoassay for rupture of amniotic membranes in pregnant women, a self-contained test used in doctor’s offices and maternity units, and joined a global initiative with the Bill and Melinda Gates Foundation to create platforms for point of care diagnosis in the developing world.