Extend the power of HPV testingThe BD Onclarity™ HPV Assay provides enhanced high-risk HPV genotyping results beyond 16 and 18, to support risk stratification and enhanced patient management.

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References: 1. WHO RHR. Cervical cancer, human papillomavirus (HPV), and HPV vaccines—key points for policy-makers and health professionals. WHO; 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. Wright TC et al. Gynecol Oncol. 2019;153(2):259-265. 6. de Sanjose et al. Lancet Oncol. 2010;11:1048-1056. 7. Stoler MH et al. Gynecol Oncol. 2018;149(3):498-505. 8. BD Onclarity HPV Assay US Package Insert [8089894].

Advancing HPV testing. Enhancing patient management.

Prepare for the changes in HPV genotype prevalenceVaccination rates and the incidence of cervical adenocarcinoma are both on the rise, making HPV genotype testing an important tool to help stratify risk and enhance patient management.

• Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but the prevalence of these genotypes is declining as vaccination rates increase1-5

• HPV high-risk genotypes 16, 18 and 45 account for 94% of cervical adenocarcinomas6

Advance HPV testing accuracy• Reduced risk of false-positive results due to lack

of cross-reactivity with low-risk HPV types8

• Designed to minimize false-negative results by including an internal cellular control, ensuring that a sample is present

Make more informed decisions• Enables you to stratify patients according to risk7

• Allows you to monitor high-risk HPV genotypes and to potentially reduce unnecessary colposcopies

Enhance patient management with the BD Onclarity™ HPV Assay.

Patient management guidance may also evolve to include genotypes beyond 16 and 18. Be ready with the assay's extended genotyping capabilities.

Co-testingHPV Primary Screening

Cytology Primary + ASCUS Reflex

Adapt to evolving screening guidelinesThe BD Onclarity™ HPV Assay is FDA approved for the paradigms below and offers the flexibility you need for changing screening guidelines.

Clarify patient risk with enhanced genotype detectionThe BD Onclarity™ HPV Assay has been extensively tested in a clinical trial among over 33,000 women representing different ages, ethnicities and vaccinated and unvaccinated populations.7

The assay detects 14 high-risk genotypes and is the only FDA-approved HPV assay to individually report genotype 45.8

• Genotype 45 causes 12% of cervical adenocarcinomas, and may be just as high-risk as genotype 186

• Patients who test positive for genotype 45 may need to be stratified into a higher risk level

16 18 45

Individual genotype reporting of 3 HR HPV types:

Individually (31, 51, 52) or concurrently (33/58, 35/39/68, 56/59/66) detects remaining HR HPV genotypes:

31 51 52 33, 58 35, 39, 68 56, 59, 66Positive or Negative Pooled Result