• Human papillomavirus (HPV) is the most common sexually transmitted virus. More than 100 distinct site–specific papillomaviral types exist, 23 of which are specific to the genital tract¹. Clinical manifestation is dependent upon epithelial location, HPV type and host–immune status. For example, some HPV types cause common warts.
• Other types of HPV, known as "high–risk" HPV DNA are found in virtually all cervical carcinomas and precursor lesions.¹

Cervical cancer is the second most common cancer among women worldwide. The American Cancer Society estimates that in 2007, about 11,150 new cases of invasive cervical cancer will diagnosed in the United States and approximately 3,670 women will die from the disease.

HPV and Cervical Cancer Prevalence

National Cancer Institute SEER data 1990–1994

• According to the World Health Organization and the National Institutes of Health, HPV is the cause of virtually all cases of cervical cancer. Studies have confirmed a strong, causal link between HPV and cervical cancer that is independent from other risk factors.
• A study published in the Journal of Pathology (Aug. 19, 1999) documented that HPV is present in virtually all cervical cancers (99.7%).
• Further studies confirm that persistent HPV infection causes cervical cancer and that a test for high–risk HPV can predict the risk of cervical cancer among women with normal Pap results.
• Almost 100 types of HPV have been identified.
• Thirteen "high risk" types are associated with cancer. Persistent infection with these high–risk types is required for cervical cancer to develop.
• However, HPV infection alone is not sufficient to induce an immediate carcinoma since malignant tumors develop only after HPV–induced lesions persist for several years.²
• HPV infection can be latent for many years. Most women will clear an HPV infection within 9–15 months. However, women with persistent high–risk HPV infection are 300 times more likely to develop HSIL.

• It used to be that the Pap test was the primary line of defense against cervical disease and cancer. But now there's a new weapon – The Digene^® HPV Test* (also known as the DNAwithPap^® Test), the only HPV test approved by the FDA for primary adjunctive screening with a Pap in women age 30 and older.
• By combining The Digene HPV Test with a Pap test, studies show that the sensitivity for high–grade cervical disease and cancer can be as high as 100%.
• National guidelines from the American College of Obstetricians and Gynecologists, the American Cancer Society and the American Society for Colposcopy and Cervical Pathology all now recommend that HPV testing be used in conjunction with the Pap for improved detection of cervical disease and cancer.
• Using The Digene^® HPV Test provides greater assurance that you are not missing cervical disease or cancer and have a better risk assessment tool for your patients.

back to top

¹ National Institutes of Health (NIH). Consensus Development Conference Statement. 1996.
² Pfister H. The role of human papilloma virus in anogenital cancer. In Lorincz AT, Reid R, editors. Human Papillomavirus 1. 2nd ed. Obstet Gynecol Clin NA 1996; 23: 579–595.
³ Franco EL. Epidemiology of anogenital warts and cancer. In: Lorincz AT, Reid R, editors. Human Papillomavirus 1. 2nd ed. Obstet Gynecol Clin NA 1996;23:597–623.
⁴ Cox JT. Clinical role of HPV DNA testing. In: Lorincz AT , Reid R, editors. Human Papillomavirus 1. 2nd ed.1996. Obstet Gynecol Clin NA 23(3):811–851.
⁵ Ferenczy A. The bethesda system (TBS): advantages and pitfalls. In: Franco E, Monsonego J, editors. New Developments in Cervical Cancer Screening and Prevention. 1997:151–158.

* "The Digene HPV Test" was approved by the US FDA and is also known to laboratories and physicians as the "hc2 High–Risk HPV DNA Test^®" and "DNAwithPap^® Test." This does not refer to the Digene product that tests for several types of the virus commonly referred to as "low–risk HPV," which are not associated with cervical cancer.