When used with a Pap, The Digene^® HPV Test* (DNAwithPap^® Test) is a more effective way to determine a woman's risk for cervical disease and cancer than Pap testing alone. The signal–amplified, nucleic acid detection–based test has been shown to be clinically effective in studies reported in more than 300 peer–reviewed publications. The following is just a sampling of the wealth of clinical information that has been derived from these studies, involving more than 40,000 women:

• High–risk HPV types have been detected in 99.7% of cases of cervical cancer, confirming that the virus must be present for cervical cancer to develop.
  Walboomers J.M.M., et al. Human Papillomavirus is a Necessary Cause of Invasive Cervical Cancer Worldwide. Journal of Pathology 1999;189:12–19.
• Women with persistent HPV infection are in excess of 300 times more likely than HPV–negative women to develop high–grade cervical disease. Persistent high–risk HPV infection (3 years or more) increases the relative risk of HSIL more than 300 times. Bory J., et al. Recurrent Human Papillomavirus Infection Detected with the Hybrid Capture 2 Assay Selects Women with Normal Cervical Smears at Risk for Developing High Grade Cervical Lesions: A Longitudinal Study of 3,091 Women. Int. J. Cancer, 2002;102:519–525.
• In an ASC–US population, the sensitivity of The Digene HPV Test for detecting high–grade precursors and cervical cancer is 96%, compared to 85% for a repeat liquid–based Pap test.
  Solomon D., et al. Comparison of Three Management Strategies for Patients with Atypical Squamous Cells of Undetermined Significance: Baseline Results from a Randomized Trial, J. Nat Cancer Inst, 2001; 93:293–299.
• The negative predictive value of combined HPV/Pap testing is 99.21% for CIN3.
  Sherman M.E., et al. Human Papillomavirus Testing, and Risk for Cervical Neoplasia: A 10–Year Cohort Analysis. Journal of the National Cancer Institute, 2003;95:46–52.
• A cohort analysis of 5,671 women older than 30 (conducted within a larger study of 7,932 women) showed that conventional cytology was 57% sensitive for HSIL, liquid cytology was 84% sensitive, and The Digene HPV Test was 100% sensitive.
  Clavel C., et al. Human Papillomavirus Testing in Primary Screening for the Detection of High–Grade Cervical Lesions: A Study of 7932 Women. Brit J Cancer, 2001; 89 (12):1616–1623.
• A study of 8,466 women undergoing routine cervical cancer screening showed that the sensitivity of the hc2 test used in conjunction with a Pap was 100% for detection of CIN2+, while that of the Pap alone was 43.5%.
  Petry K., et al. Inclusion of HPV testing in routine cervical cancer screening for women above 29 years in Germany: results for 8466 patients, British Journal of Cancer,2003;88:1570–1577.
• In another study of more than 11,000 women, The Digene HPV Test was shown to be 97% sensitive for CIN2+, compared to 77% for conventional Paps resulting in ASC–US or abnormal results. The study also documented that women infected with high–risk HPV and who have normal or borderline cytology can be managed as effectively with repeat testing after 12 months with immediate colposcopy.
  Cuzick, J. et al. Management of women who test positive for high–risk types of human papillomavirus: the HART study. The Lancet 2003;362:1871–76.
• Still another study demonstrated that HPV testing is a more sensitive indicator of high–grade CIN than either conventional or liquid Pap tests alone. Screening with both an HPV and Pap test offered a sensitivity and negative predictive value of almost 100%.Twenty–one percent of women who were persistently positive for high–risk HPV DNA types when tested with hc2 were diagnosed with CIN2/3 within 36 months, compared to only 0.08% of women who were initially HPV–negative.
  Lorincz, A., Richart, R. Human Papillomavirus DNA Testing As An Adjunct To Cytology In Cervical Screening Programs. APLM 2003;127:959–968.
• Since HPV DNA testing is more sensitive than cervical cytology in detecting CIN2 and CIN3, women with negative concurrent test results can be reassured that their risk of unidentified CIN2 and CIN3 or cervical cancer is approximately 1 in 1,000.
  ACOG Practice Bulletin No. 61, "Human Papillomavirus. Clinical Management Guidelines for Obstetrician–Gynecologists." April 2005.

Select reprints are available upon request, if you are submitting a question or request for information/literature, please specify where you are located and if you are a healthcare provider. Send an email hpvtest.literature@digene.com to request publications/reprints of HPV articles. Not all of the articles listed above are available.

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* "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.