BD Onclarity™ HPV Assay empowers you to meet the needs of the rapidly changing cervical cancer screening landscape

Flexibility in screening paradigm

BD Onclarity™ HPV Assay is CE-marked and FDA-approved for primary screening and fulfils the Meijer criteria, offering flexibility to adapt to evolving guidelines.1,2

HPV primary screening

Co-testing

Reflex testing in
cytology primary
screening

Fully integrated end-to-end
solutions

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Flexibility to choose sample type

The BD Onclarity™ HPV Assay uses a harmonised workflow regardless of the specimen type and is also validated for HPV primary screening on self-collected samples.1

BD Onclarity™ HPV Assay is validated for use with:1

  • Liquid-based cytology specimens
  • Cervical brush specimens
  • Self-collected vaginal specimens

BD solutions for HPV testing

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BD Onclarity™ HPV Assay is the only HPV test providing extended genotyping both CE-marked and FDA-approved for HPV primary screening, triage of ASC-US cytology and co-testing.4,5

ASC-US, atypical squamous cells of undetermined significance; FDA, Food and Drug Administration; HPV, human papillomavirus.

1. BD Onclarity™ HPV Assay Package Insert [8089899].
2. BD Onclarity™ HPV Assay US Package Insert [8089894].
3. Meijer CJLM et al. Int J Cancer. 2009;124(3):516–20.
4. Arbyn M et al. Clin Microbiol Infect. 2021;27(8):1083–95.
5. Salazar KL et al. J Am Soc Cytopathol. 2019;8(5):284–92.