careHPV Test Receives WHO Prequalification Status for Cervical Cancer Screening

The careHPV Test, a molecular diagnostic for high-risk human papillomavirus (HPV) designed to screen women in low-resource settings, has been added to the World Health Organization (WHO) list of prequalified in vitro diagnostics (IVDs). HPV is the primary cause of cervical cancer, so screening women for the presence of the virus is a critical aspect for prevention and early treatment of the disease. The careHPV Test was launched globally in 2010 and, through numerous pilot studies, has demonstrated to be a more sensitive alternative to cytology and visual inspection based methods for the detection of precancerous cell abnormalities. The WHO’s evidence-based listing is expected to expand the availability of this critical diagnostic tool in countries that rely on the global organization’s list in making purchasing decisions. The WHO Prequalification status will significantly broaden access to HPV DNA testing to areas of the world with a high burden of cervical cancer.

The careHPV Test combines advanced molecular technologies with 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.

“High-quality molecular HPV tests that are easy to run are critical for expansion of cervical cancer prevention strategies in low-resource settings. WHO prequalification of careHPV is excellent news that will help countries to choose the best and most suitable technology for their programs. 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,” said Silvia de Sanjosé, MD, PhD, MPH, Director of 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 pressing health challenges.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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