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Human Papillomavirus (HPV) Molecular Detection with Genotyping

New test offers high-risk HPV detection (14 high-risk types) with specific genotyping for HPV-16 and HPV-18




February 2014

To better accommodate important updates in the screening guidelines for HPV, an infection present in 20 million people in the United States and resulting in 6.2 million new infections per year, Mayo Medical Laboratories now offers testing for the detection of high-risk HPV (hrHPV), with genotyping for HPV-16 and HPV-18.

Featured Test

  • HPV / Human Papillomavirus (HPV) DNA Detection with Genotyping,
    High-Risk Types by PCR: ThinPrep | SurePath

Advantages of this New Test

  • 3 -in-1 testing for every sample: High-risk HPV detection (14 high-risk types) with specific genotyping for HPV-16 and HPV-18
  • Enables women with positive results for HPV-16 and/or HPV-18 to be referred to colposcopy right away
  • Performed on cervical/endocervical and vaginal samples collected in ThinPrep or SurePath media

 

Importance of Triaging Women with High-Risk HPV

A recent study published in the American Journal of Clinical Pathology1 evaluated the role of HPV-16 and -18 genotyping in women with a positive high risk HPV Nucleic Acid Amplification Test (NAAT) result, but negative cytology. The data from this study suggested:

  • Women with HPV-16 or HPV-18 had an absolute risk of 11.4% for the development of grade 2 cervical intraepithelial neoplasia (CIN-2) or greater lesions
  • Women with ‘other’ high-risk HPV that was determined not to be genotypes 16 or 18 had an absolute risk of 6.1%
  • Women that were negative for high-risk HPV altogether had an absolute risk of only 0.8%

The conclusion that genotyping is important in triaging women with hrHPV has been supported in several studies, including one that concluded “Incorporating screening with HPV and triage of HPV-positive women by a combination of genotyping for HPV-16/18 and cytology provided a good balance between maximizing sensitivity and specificity by limiting the number of colposcopies.”2

High-grade Disease Occurs Mostly in HPV 16/18+

A seminal study of 20,810 women with normal cytology in the Kaiser Permanente healthcare system found that women with normal cytology who were HPV-16+ and HPV-18+ had highest risk of developing grade 3 or higher CIN

10 Year Cumulative Incidence Reat of CIN3 by hrHPV Status

 

HPV-16 and HPV-18 are the Most Prevalent HR-HPV Genotypes Causing Cervical Cancer

Prevalence of hrHPV Genotpyes

Both graphs adapted from “cobas® HPV Test: Know the Risk” educational booklet. Used with permission from Roche Molecular Systems, Branchburg, NJ."

References

  1. Wright TC, Stoler MH, Sharma A et al: Evaluation of HPV-16 and HPV-18 genotyping for the triage of women with high-risk HPV+ cytology-negative results. Am J Clin Pathol 2011;136:578-586
  2. Cox JT, Castle PE, Behrens CM, ey al: Comparison of cervical cancer screening strategies incorporating different combinations of cytology, HPV testing, and genotyping for HPV 16/18: results from the ATHENA HPV study. Am J Obstet Gynecol 2013;208:184.e1-184.e11
  3. Khan MJ, Castle PE, Lorincz AT, et al. The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice. J Natl Cancer Inst. 2005;97:1072-1079.
  4. Bosch FX, de Sanjosé S. Chapter 1: human papillomavirus and cervical cancer–burden and assessment of causality. J Natl Cancer Inst Monogr. 2003;31:3-13.

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