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In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk human papillomavirus [hrHPV] testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective U.S.-based registration study. Thirteen experts, including representatives from the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the U.S. Food and Drug Administration (FDA) for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.

Pediatr Infect Dis J 2006;25: S65-S81)I n theory, recognition that a pandemic infection is responsible for more than half a million cancer cases each year would attract huge media attention, and infection control would become the subject of preventative efforts from all global health agencies. Media attention would likely be particularly acute if the majority of deaths was among women rearing families in the developing world and if the disease were sexually transmitted. A vaccine capable of preventing the disease would be diligently pursued and, once available, promptly distributed for the health and welfare of humankind.Human papillomavirus (HPV) infection fits this scenario; however, HPV has yet to make an impact on either the media or public thinking as outlined in the previous paragraph, even though the link between HPV infection and cervical cancer has been recognized for more than 20 years. It is possible that the delay between acquisition of HPV infection and death, on average 20 years, or the asymptomatic nature of acute infection, greatly diminishes the immediacy of the public impact of this epidemic. Although apparently safe vaccines capable of preventing Ͼ90% of HPV infections are in the offing, focus on prevention of HPV associated deaths is being diverted by debates about the morality of vaccination against a sexually transmitted infection and its hypothesized impact on human sexual behavior.A roundtable discussion was held in Vancouver, British Columbia to consider and develop a consensus statement among informed clinicians about HPV infection, the role of HPV in cervical cancer, the role of HPV in other anogenital malignancies, the role of HPV in genital warts and the prospects for control of the global HPV pandemic through vaccination. The consensus statements outlined within have been agreed upon and represent the informed opinions of this expert working group. CONSENSUS 1: GENITAL HPV-ASSOCIATED DISEASE IS A MAJOR HEALTH CARE BURDEN • HPV infection is the cause of genital warts and mostpreinvasive and invasive cancers of the lower anogenital tract.• Clinically or histologically recognized genital warts, abnormal cervical cytology and preinvasive or invasive cancer are major causes of physical and psychologic morbidity and of treatment-related cost.Papillomaviruses are small, nonenveloped viruses that infect cutaneous and mucosal epithelial tissues. More than 100 types of HPV have been identified, of which more than 40 infect the genital mucosa (Fig. 1). 1 The life cycle of HPV is dependent on active cellular replication and subsequent cellular division. Because the uppermost layers of the squamous epithelium have undergone terminal differentiation and are no longer dividing, HPV requires access to the undifferentiated basal layer of the epithelium to initiate a productive infection cycle. Current hypotheses suggest that HPV accesses the underlying basal layer through naturally thin epithelial layers, such as those found in the transformation zones of the cervix or anus, or through microabrasions...