Managing HPV: A New Era in Patient Care – DNA Testing

(Published June 2009)

Screening for HPV-Related Cancer: HPV DNA Testing

Tests are available to identify current human papillomavirus (HPV) infection by detecting the presence of HPV DNA. Currently, three tests have been approved by the Food and Drug Administration (FDA) for this use. The Hybrid Capture II^® HPV Test, detects 13 of the 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68 but not 82)¹ and Cervista™ HPV HR detects these same 13 HR types of HPV as well as Type 66.² Cervista™ HPV 16/18, which detects just types 16 & 18, can be used alongside or as a follow up to HR HPV testing. Types 16 & 18 are the high risk types associated with 70% of all cervical cancers.³ The tests assess whether one or more of these types of high-risk HPV are present; they do not identify the individual HPV type. Testing for low-risk HPV types should not be performed because, according to national guidelines, “there is no clinical utility in testing for other (nononcogenic) types.”⁴ The laboratory request slip should be marked appropriately to ensure that only testing for high-risk HPV types is performed.

Use of HPV Testing

HPV testing to screen for cervical cancer has two main benefits:

• First, it allows for less frequent screening. A normal Pap test result and a negative HPV test result give a high assurance that cervical cancer is not present and is not likely to occur in the next few years. In fact, when both tests are negative, the chance is 1 in 1,000 that CIN-2,3 is present and less than 2 in 1,000 that CIN-2,3 will develop within three years.⁵
• Second, HPV DNA testing identifies women who need increased surveillance. A positive HR HPV test result paired with a normal Pap test result reflects either a false-negative Pap test result or increased risk for development of CIN-2,3 and cancer.⁵ For this reason, women who have these results require more frequent follow-up. Women who are found to be positive for type 16 or 18 are at highest risk and should proceed to immediate colposcopy.⁶

Frequency of Screening

Research has shown that screening every 3 years with a combination of cytology and HPV testing in women age 30 years or older is equivalent to or better than cervical cancer screening with annual Pap testing.⁸ For this reason, national guidelines recommend that women who have negative HPV test results and negative cytology should be screened no more frequently than every three years.⁴

Management of Results: Positive HPV and Negative Pap Test

Of the women who undergo screening with a combination of Pap testing and HPV DNA testing, many of those who test positive for HPV will have normal Pap test results.⁴ National guidelines recommend follow-up at 12 months with repeat Pap testing and HPV testing.⁴ Colposcopy is recommended for women who test positive for HPV or have LSIL or greater Pap results on repeat testing at 12 months. Rescreening in three years is recommended for women who test negative on both tests on repeat testing at 12 months.⁴

References:

1. Centers for Disease Control and Prevention. Human Papillomavirus: HPV Information for Clinicians. November 2006.
2. Food and Drug Administration. New Device Approval Cervista™ HPV HR and Genfind™ DNA Extraction Kit – P080014.
3. Food and Drug Administration. New Device Approval Cervista™ HPV 16/18– P080015.
4. Wright TC, Jr, Massad LS, Dunton CJ, Spitzer M, Wilkinson EJ, Solomon D. 2006 Consensus Guidelines for the Management of Women with Abnormal Cervical Cancer Screening Tests. Am J Obstet Gynecol. 2007;197(4):346-55.
5. Wright T, Schiffman M, Solomon D, Cox JT, Garcia F, Goldie S, et al. Interim guidance for the use of human papillomavirus DNA testing as an adjunct to cervical cytology for screening. Obst Gynecol. 2004;2:304-9.
6. ASCCP. HPV Genotyping Clinical Update. April 2009. Available at: www.asccp.org/pdfs/consensus/clinical_update_20090408.pdf. Accessed May 26, 2009.
7. ASCCP Educate the Educators: HPV and the HPV Vaccines 2006, ASCCP [slide presentation].
8. Goldie SJ, Kim JJ, Wright TC. Cost-effectiveness of human papillomavirus DNA testing for cervical cancer screening in women aged 30 years or more. Obstet Gynecol. 2004;103:619-31.