Primary Adjunctive Screening (for women 30 and older)

Why incorporate the digene HPV 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 signal 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 greater risk of 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 and Melkert et al., 1993. Int J Canc 53:919.

  • The digene HPV Test offers clinicians an objective measure of a woman's risk of developing cervical cancer.

  • Used alone, a Pap may miss cervical disease up to 35 percent of the time. But any type of Pap in combination with the digene HPV Test detects the cause of high-grade cervical disease and cancer with sensitivity up to 100 percent – preventing false-negative results. 6 

  • In a major U.S. study, the negative predictive value for the digene HPV Test/Pap combination was 99.21 percent for CIN 3 and cancer.3

  • Women with persistent high-risk HPV infection are 300 times more likely to develop HSIL than those without.5 

     

    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 three years.

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

  • The digene HPV Test used together with a Pap is more sensitive and has better negative predictive value than any type of 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

 

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
10 Mayrand MH, Duarte-Franco E, Rodrigues I, Walter SD, Hanley J, Ferenczy A, Ratnam S, Coutlée F, Franco EL, Human Papillomavirus DNA versus Pananicolaou Screening Tests for Cervical Cancer. N. Engl. J. Med. 357(16):1579-88 (2007)
11 Ronco G, Segnan N, Giorgi-Rossi P, Zappa M, Casadei GP, Carozzi F, Dalla Palma P, Del Mistro A, Folicaldi S, Gillio-Tos A, Nardo G, Naldoni C, Schincaglia P, Zorzi M, Confortini M, Cuzick J. Human papillomavirus testing and liquid-based cytology: results at recruitment from the new technologies for cervical cancer randomized controlled trial. J Natl Cancer Inst. 98(11):765-74 (2006)
12 Cytyc package insert; ThinPrep® Imaging System Table 2.
13 Biscotti CV, Dawson AE, Dziura B, et al. Assisted primary screening using the automated ThinPrep imaging system.Am J Clin Pathol. 2005;123:281-287.

* The FDA-approved and CE-marked "digene HPV Test" is also known to laboratories and physicians as the "digene HC2 HPV DNA Test®". This does not refer to the QIAGEN product that tests for several types of the virus commonly referred to as "low-risk HPV", which are not associated with cervical cancer.