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What Does “Extended Genotyping” Mean In The Context of HPV Testing ?

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Extended genotyping allows for a more precise way to measure your patient’s risk for developing cervical pre-cancer and cancer vs. a pooled, high-risk assay3,9

Genotyping Comparison

HPV assays with partial genotyping

Report multiple high-risk HPV (hr-HPV) genotypes in a single, pooled result1


BD Onclarity™ HPV Assay with extended genotyping

Reports 6 hr-HPV genotypes individually and the other 8 hr-HPV genotypes in strategic, small groups1,2

 

HPV assays with partial genotyping

May mask the true risk of CIN3+ disease due to HPV 31 and will likely lead to a one-year follow-up recommendation instead of an immediate colposcopy referral3–5

BD Onclarity™ HPV Assay with extended genotyping

Can individually identify HPV 31, which poses a similar risk for cervical pre-cancer and cancer as compared to HPV 18(4)

 

HPV assays with partial genotyping

Prohibits monitoring of genotype-specific HPV persistence beyond HPV 16 and 184

BD Onclarity™ HPV Assay with extended genotyping

Can track genotype-specific high-risk HPV persistence, the most important determinant of cervical cancer risk in women who test HPV-positive, regardless of HPV genotype4,6–8

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Shape the future of cervical cancer screening: Identify HPV 31

The BD Onclarity™ HPV Assay with extended genotyping is the only FDA-approved HPV test that individually identifies HPV 31, which poses a similar risk for cervical pre-cancer and cancer as compared to HPV 18 and should be managed similarly.3,4,10-14

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Additional resources

References

* CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; hr, high risk
  1. Salazar K et al. J Am Soc Cytopath. 2019;8:284–92.
  2. BD OnclarityTM HPV Assay US Package Insert [8089894].
  3. Perkins RB et al. J Low Genit Tract Dis. 2020;24:102–31.
  4. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1–13.
  5. Stoler MH et al. Am J Clin Pathol. 2019;151(4):433–42.
  6. Elfgren et al. Am J Obstet Gynecol. 2017;216:264.e1-7.
  7. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
  8. Bodily J, Laimins LA. Trends Microbiol. 2011;19(1):33–9.
  9. Demarco M et al. E Clinical Medicine 22. 2020;100293.
  10. Monsonego J et al. Gynecol Oncol. 2015;10:1016.
  11. Schiffman M et al. Gynecol Oncol. 2015;138(3):573-578.
  12. Schiffman M et al. Int J Cancer. 2016:139:2606-2615.
  13. Schiffman M et al. J Clin Microbiol. 2015;53(1):52-59
  14. Stoler MH et al. Gynecol Oncol. 2019;153(1):26-33.

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