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Improve Cervical Cancer Risk Assessment

Results you can trust.

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Shape the future of cervical cancer screening with BD Onclarity™ HPV Assay:

 

  • Clinically validated to simultaneously detect 14 high-risk HPV (hr-HPV) genotypes, allowing you to focus on patients with higher risk
  • Provides an individual result for HPV 31, which poses a similar risk for cervical pre-cancer and cancer as compared to HPV 181
  • Individually identifies 6 hr-HPV genotypes to allow for genotype-specific HPV persistence tracking, the most important determinant of cervical cancer risk in women who test HPV-positive1-4
  • The only Health Canada approved HPV assay that offers extended genotyping5,6

The BD Onclarity™ HPV assay is designed to reduce the risk of false-positive results due to lack of cross-reactivity with low-risk HPV types6

HPV assays can show cross-reactivity with other, low-risk HPV genotypes, meaning that the HPV assay would generate a positive result for a hr-HPV genotype when actually a low-risk or non-oncogenic HPV genotype was detected.7

The BD Onclarity™ HPV Assay shows low cross-reactivity as compared to the HC2 HPV Assay.8

BD Onclarity™ HPV assay is designed to minimize false-negative results by:

  • Including an internal control to provide confidence that sample collection was adequate and the entire assay process functioned properly7
    • In assays where there is no internal control the system would report a negative result rather than a test failure5
  • Targeting the E6/E7 region of the HPV viral genome rather than the L1 region, which can undergo deletion during HPV DNA integration9
  • Oncogenes E6 and E7 are required for cell transformation and these gene products are directly involved in causing cervical disease.9
  • The L1 region can undergo deletion when the HPV virus integrates into the human genome leading to false-negative results.9

The BD Onclarity™ HPV Assay can detect clinical levels of any target HPV type in the presence of up to one million copies of another competing type.

In other words, you won’t miss the less abundant HPV type(s) in your patients.10

The BD Onclarity™ HPV Assay is designed to provide you with the detailed results you need to better support patients with higher risk of disease.11 Detects 14 hr-HPV genotypes and reports up to 9 results6

  • Individual results for HPV genotypes with highest-risk for disease: 16, 18, 45, 31, 51 and 52
  • Strategic grouped results for lower risk HPV genotypes: 35/39/68, 33/58 and 56/59/66

Learn more about extended genotyping
with the BD Onclarity™ HPV Assay

Additional resources

  • Bullseye Icon

    WHAT DOES “EXTENDED GENOTYPING” MEAN IN THE CONTEXT OF HPV TESTING?

    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 assay.

    Learn more
  • Partial genotyping vs Extended genotyping

    SHAPE THE FUTURE OF CERVICAL CANCER SCREENING.

    Bd Onclarity™ HPV Assay is the only FDA and Health Canada approved HPV test that individually identifies HPV 31

    Learn more

References

1. Bonde JH et al. J Low Genit Tract Dis. 2020;24(1):1-13.
2. Elfgren et al. Am J Obstet Gynecol. 2017;216:264.e1–7.
3. Radley D et al. Hum Vaccin Immunother. 2016;12(3):768–72.
4. Bodily J, Laimins LA. Trends Microbiol. 2011;19(1):33–9.
5. Salazar K et al. J Am Soc Cytopath. 2019;8:284–92.
6. BD OnclarityTM HPV Assay US Package Insert [8089894].
7. Preisler S et al. BMC Cancer. 2016;16:510.
8. Ejegod DM et al. Papillomavirus Res 2 2016;31–7.
9. Vaughan LM and Malinowski DP. Rev Bras Ginecol Obstet. 2019;41(5):357–9.
10. Wright TC et al. Am J Clin Pathol. 2014;142(1):43–50.
11. Bottari F et al. J Clin Microbiol. 2015;53:2109–14.

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