Background: With nearly 500,000 new cases and 274,000 deaths annually, cervical cancer is the second most common cancer among women worldwide. The understanding that persistent infection with one of ~15 high risk (HR) Human Papillomavirus (HPV) is required for cervical carcinogenesis led to the successful development of vaccines to prevent HPV infection as well as to recommendations to incorporate HPV testing into cervical cancer screening algorithms. Cervical cancer control strategies ideally will include a combination of screening and vaccination. However 80% of the deaths from cervical cancer occur in regions of the world with the lowest resources. With Gates Foundation funding, PATH developed CareHPV, an adaptation of the FDA approved Digene HPV test for use in low resource settings. This has promise for screening, but does not provide type-specific information needed to monitor HPV vaccine impact. Due to the long natural history of cervical cancer, impact of the vaccine on this endpoint will not be seen for decades after widespread vaccine uptake. The ability to detect an impact on an early biologic endpoint is helpful to ensure the commitment of ministries of health to ongoing expensive HPV vaccination.
Public Health Impact: A simple point of care test for HPV typing would facilitate cervical cancer control in low resource settings by supporting both vaccination and screening. In developed countries the test would reduce loss to follow-up by allowing definitive treatment decisions to be made at one visit. With increased recognition of the role of HPV in anal and oropharyngeal cancers, the test may have impact on cancers at those sites as well. There is an expanding market for HPV tests. While HPV typing assays are available, all are highly complex and expensive requiring at least one day turnaround.
Examples of specific research areas of interest include, but are not limited to: Develop a point-of care device for rapid detection and typing of HR HPV from a variety of biological samples such as cervical, anal and penile swabs. The device should incorporate simplified methods for sample handling, and may utilize target and or signal amplification to identify 14 high risk HPV types (e.g., HPV 16, 18, etc.). CDC is interested in the application of biosensors, microfluidic platform, and nanoparticles in the successful development of a fully integrated system for point of care HPV typing.