Qiagen NV, Hilden, Germany, and Germantown, Md, has announced that its CareHPV test has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). Designed to screen women in low-resource settings, the CareHPV test is a molecular diagnostic for high-risk strains of human papilloma virus (HPV).

The CareHPV test was launched globally in 2010 and through numerous pilot studies has been shown to be a more sensitive alternative to cytology and visual inspection-based methods for the detection of precancerous cell abnormalities. HPV is the primary cause of cervical cancer, so screening women for the presence of the virus is a critical step toward prevention and early treatment of the deadly cancer.

WHO’s evidence-based listing is expected to expand the availability of this critical diagnostic tool in countries that rely on the list for making purchasing decisions. WHO prequalification status will significantly broaden access to HPV DNA testing in areas of the world with a high burden of cervical cancer.

Photo Bernard Thierry

Thierry Bernard, Qiagen.

“The WHO prequalified IVD listing is a ‘stamp of approval’ for our innovative CareHPV test, and this will encourage authorities to adopt efficient, highly accurate HPV screening for prevention of cervical cancer in settings with limited healthcare infrastructure,” says Thierry Bernard, senior vice president for the molecular diagnostics business area at Qiagen. “China routinely uses CareHPV in rural or low-resource areas, and Qiagen partners with non-governmental organizations and health ministries in developing countries. We expect the WHO listing to drive further dissemination of this important tool for women’s health.”

Qiagen’s fast, portable, and easy-to-use CareHPV test combines advanced molecular technologies with innovative design features for areas lacking consistent electricity, water, or a controlled laboratory environment. For example, the system has color-coded, easy-to-understand menus, and self-contained reagents. The test tolerates temperature variations that occur in rural clinics lacking refrigeration due to limited electricity or water, and can provide results much faster than traditional laboratory-based methodologies. The CareHPV test was developed with support from PATH, an international nonprofit organization, and is manufactured by Qiagen in Shenzhen, China.

“High-quality molecular HPV tests that are easy to run are critical for expansion of cervical cancer prevention strategies in low-resource settings,” says Silvia de Sanjosé, MD, PhD, MPH, director of the Scale-Up project at PATH, a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges.

“WHO prequalification of CareHPV is excellent news that will help countries to choose the best and most suitable technology for their programs,” says de Sanjosé, “To achieve higher coverage of at-risk women and make an impact in cervical cancer prevention, we need to move to affordable and cost-effective strategies with HPV testing, leveraging self-sampling potentially.”

To learn more, visit Qiagen.