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The High-Risk HPV Test:

A Breakthrough in Cervical Cancer Screening
· In a Pap test, a laboratory technician visually examines a sample of cervical cells under a microscope to look for abnormal changes. Thus, the findings – no matter what type is used – are inexact, and are subject to human error and interpretation.
· The Digene® HPV Test (the only such test approved by the FDA) uses advanced molecular technology to detect the DNA (genetic material) of 13 high-risk types of HPV, the virus shown to actually cause virtually all cases of cervical cancer.
· The test is done at the same time as the Pap, so women don’t need to do anything more than ask for it.
· The Digene HPV Test is based on proprietary “Hybrid Capture” technology, which combines two innovations from the rapidly evolving field of life sciences – DNA/RNA probes and monoclonal antibodies – to allow rapid, standardized gene testing in virtually any laboratory setting.

· The Digene HPV Test was first approved in 1999 for follow-up evaluation in women of all ages whose Pap results are uncertain – typically referred to as “ASC-US” (atypical squamous cells of undetermined significance).
· In 2003, the U.S. Food and Drug Administration (FDA) approved the Digene HPV Test for cervical cancer screening, in conjunction with a Pap, in women age 30 and older.
· Use of HPV testing for routine screening is recognized in guidelines issued by the American College of Obstetricians and Gynecologists, the American Cancer Society and the Association of Reproductive Health Professionals.
· The majority of insurance companies cover the HPV test for routine screening.
· By combining the HPV and Pap tests, the ability to identify women at risk for cervical cancer is increased to virtually 100 percent.1
· In one study, Digene’s HPV test identified 100 percent of the women with advanced cervical disease (cervical intraepithelial neoplasia [CIN] grades 2 and 3), compared to only 58 percent identified by the conventional Pap and 84 percent by the newer, “liquid-based” Pap.2
· In study to study, the sensitivity of Digene’s HPV test consistently exceeds the Pap.3
For more information, visit www.thehpvtest.com

J Cuzick, A Szarewski, H Cubie, G Hulman et al, “Management of Women Who Test Positive for High-Risk Types of Human Papillomavirus: The Hart Study.” The Lancet 2003 362: 1871-1876.

2 Clavel C, Masure M, Bory JP, Putaud I, Mangeonjean C, Lorenzato F et al. Human papillomavirus Testing in Primary Screening for the Detection of High-Grade Cervical Lesions: A Study of 7932 Women. Br J Cancer 2001; 89(12): 1616-1623.

3 Lorincz A, Richart R. Human Papillomavirus DNA Testing as an Adjunct to Cytology in Cervical Screening Programs. Arch Pathol Lab Med. 2003; 127: 959-968.