Why incorporate The Digene^® HPV Test (DNAwithPap^® Test) into your cervical cancer screening program for women 30 and older?

• Epidemiology data have shown that the prevalence of HPV in women generally decreases over time, while the incidence of cervical cancer increases.
• The point at which HPV prevalence meets cervical cancer incidence is around the age of 30, which supports the rationale for primary adjunctive screening (HPV + Pap) in women 30 and older.
• Identification of high–risk HPV DNA in this age group is more likely to represent persistent infection and increased risk of cervical disease.
• In fact, studies have shown that women older than 30 with normal cytology who are positive for high–risk HPV have a 116-fold risk for developing high–grade lesions compared with similar women who are HPV–negative.¹

HPV and Cervical Cancer Prevalence – National Cancer Institute SEER data 1990–1994

• The Digene^® HPV Test offers clinicians the first objective measure of a woman's risk for developing cervical cancer.
• The Digene^® HPV Test, used in combination with the Pap, determines with greater than 99% confidence which of your patients are at very low risk of developing HSIL before their next routine visit.
• The negative predictive value for the Pap combined with The Digene^® HPV Test was 99.21% for CIN3 or cancer in a major U.S. study.³
• Women with persistent high–risk HPV infection are 300 times more likely to develop HSIL.⁵
• The Digene^® HPV Test together with the Pap is more sensitive in determining the presence of disease than a Pap test alone.⁶

Sensitivity for detection of HSIL

Based on a cohort analysis of 5,671 women age >30 years within a study that included 7,932 women ages 15–76 (median age of 34). Clavel, B J Cancer, 2001⁶

A negative HPV test and a normal Pap result provide confidence that a woman does not have, and is not likely to develop, high–grade cervical disease or cancer within the next 3 years.

Clinical data suggest and recommendations from ACOG, ACS, AMWA, NPWH and ARHP state that women who have negative results on both a Pap test and The Digene^® HPV Test are at virtually no risk of developing cervical disease or cancer for up to 3 years.

• The Digene^® HPV Test used together with the Pap is more sensitive and has better negative predictive value than the Pap alone.
• This combination has been shown in several studies to be as reliable in assessing absence of disease as three successive, normal annual Paps.^7,8,9

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Click here to review treatment algorithms for the management of women based on cytology and HPV tests.

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References
¹ Melkert PW, Hopman E, van den Brule AJ, et al. Prevalence of HPV in cytomorphologically normal cervical smears, as determined by the polymerase chain reaction, is aged–dependent. Int J Cancer 1993; 53: 919–23.
² ACOG Practice Bulletin No. 45, "Cervical Cytology Screening. Clinical Management Guidelines for Obstetrician–Gynecologists." August 2003.
³ Sherman ME, Lorincz A, Scott DR, et al. Baseline Cytology, Human Papillomavirus Testing, and Risk for Cervical Neoplasia: A 10–Year Cohort Analysis. J Nat Cancer Inst, 2003; 95 (1): 46–52.
⁴ Bory JP, Cucherousset J, Lorenzato M, et al. Recurrent Human Papillomavirus Infection, Detected with the Hybrid Capture II 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.
⁵ Clavel C, Masure M, Bory J–P, 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.
⁶ Saslow D, Runowicz C, Solomon D, et al. American Cancer Society Guideline for the Early Detection of Cervical Neoplasia and Cancer. CA Cancer J Clin, 2002; 52: 342–362.
⁷ Sherman ME, Lorincz A, Scott DR, et al. Baseline Cytology, Human Papillomavirus Testing, and risk for Cervical Neoplasia: A 10–Year Cohort Analysis. J Nat Cancer Inst, 2003; 95 (1): 46–52
⁸ Clavel C, et al. Negative human papillomavirus testing in normal smears selects a population at low risk for developing high–grade cervical lesions. Brit J Cancer. 2004; 90:1803–1808.
⁹ Cuzick J, et al. Management of women who test positive for high–risk types of human papillomavirus: the HART study. LANCET. 2003; 362:1871–1876

* "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.