Assays

Extend the power of HPV testing

The BD Onclarity™ HPV Assay provides extended high-risk HPV genotyping results beyond 16 and 18, to support risk stratification and enhanced patient management

Support risk stratification

Extended genotyping supports risk stratification and persistence monitoring to guide patient management7-11

  • Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but the prevalence of these genotypes is declining as vaccination rates increase1-5
  • Genotypes 31/33/58 have a CIN3+ risk similar to genotype 18, but 51/35/39/68/59/56/66 have a much lower risk6,7
  • The BD Onclarity™ HPV assay reports individual results for 6 of the 14 high-risk genotypes and grouped results for the remaining 8 high-risk genotypes8
genotyping table
References

1. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007.  2. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.  3. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.  4. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.  5. Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.  6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.  7. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.  8. BD Onclarity HPV Assay US Package Insert [8089894]  9. Osbourne et al. Vaccine. 33(2015)201-208.  10. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.  11. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.  12. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.  13. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.  14. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.  15. Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi: 10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.  16. Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.  17. Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

Adapt to evolving screening guidelines

In the post-vaccination era the prevalence of high-risk genotypes is changing making it crucial to identify high-risk genotypes individually9

The BD Onclarity™ HPV assay is FDA-approved for extended genotyping, offering the flexibility you need to adapt to changing clinical landscape and screening guidelines

screening icon

HPV primary
screening

co-testing icon

Co-testing

ASCUS reflex icon

Cytology primary +
ASCUS reflex

References

1. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007.  2. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.  3. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.  4. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.  5. Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.  6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.  7. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.  8. BD Onclarity HPV Assay US Package Insert [8089894]  9. Osbourne et al. Vaccine. 33(2015)201-208.  10. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.  11. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.  12. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.  13. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.  14. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.  15. Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi: 10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.  16. Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.  17. Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

Advance HPV testing accuracy and make more informed decisions

The BD Onclarity™ HPV assay is designed to minimize the risk of false-negative results by:

  • Including an internal cellular control, verifying that a sample is present8
  • Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can be deleted during HPV DNA integration8
  • The BD Onclarity™ HPV assay is designed to minimize the risk of false-positive results by lacking cross-reactivity with low-risk HPV types8
  • The BD Onclarity™ HPV assay with extended genotyping enables you to stratify patients according to risk10
  • Make more informed decisions with the extended genotyping information you need to assess each patient’s risk for confident follow-up decisions10-14
References

1. World Health Organization, Department of Reproductive Health and Research. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. 2007.  2. Oliver SE et al. J Infect Dis. 2017;216(5):594–603.  3. Drolet M et al. Lancet Infect Dis. 2015;15(5):565–580.  4. Garland SM et al. Clin Infect Dis. 2016;63(4):519–527.  5. Stoler et al. Clin Infect Dis. 2019 ;153(2) :259-265.  6. Schiffman M et al. Gynecol Oncol. 2015;138(3):573–578.  7. Schiffman M et al. Int J Cancer. 2016;139(11):2606–2615.  8. BD Onclarity HPV Assay US Package Insert [8089894]  9. Osbourne et al. Vaccine. 33(2015)201-208.  10. Stoler MH et al. Gynecol Oncol. 2019;153(1):26–33.  11. Bonde J et al. Int J Cancer. 2019; doi:10.1002/ijc.32291.  12. Elfgren K et al. Am J Obstet Gynecol. 2017;216(3):264.e1–264.e7.  13. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–772.  14. Bottari F et al. J Low Genit Tract Dis. 2019;23(1):39–42.  15. Perkins RB, Fuzzell LN, Lake P, McIntyre M, Nayar R, Saraiya M, Loukissas J, Felder T, Guido RS, Vadaparampil ST. Incorporating Stakeholder Feedback in Guidelines Development for the Management of Abnormal Cervical Cancer Screening Tests. J Low Genit Tract Dis. 2020 Apr;24(2):167-177. doi: 10.1097/LGT.0000000000000524. PMID: 32243312; PMCID: PMC7147423.  16. Gage JC, Schiffman M, Katki HA, Castle PE, Fetterman B, Wentzensen N, Poitras NE, Lorey T, Cheung LC, Kinney WK. Reassurance against future risk of precancer and cancer conferred by a negative human papillomavirus test. J Natl Cancer Inst. 2014 Jul 18;106(8):dju153. doi: 10.1093/jnci/dju153. PMID: 25038467; PMCID: PMC4111283.  17. Wright TC Jr, Stoler MH, Parvu V, Yanson K, Cooper C, Andrews J. Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21 years of age, with ASC-US or LSIL cytology. Gynecol Oncol. 2019 Aug;154(2):360-367. doi: 10.1016/j.ygyno.2019.05.012. Epub 2019 May 31. PMID: 31160073.

Contact us to discuss how we can support your cervical cancer screening needs.

Contact us

Contact Us