BD Onclarity™ HPV Assay by BD Diagnostics

Manufacturer BD Diagnostics

The BD Onclarity™ HPV Assay is FDA-approved and CE-IVD marked for extended genotyping, offering the flexibility you need to adapt to changing screening guidelines and evolving patient management guidance.


BD Onclarity™ HPV Assay by BD Diagnostics product image
BD Onclarity™ HPV Assay

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The BD Onclarity™ HPV Assay is FDA-approved and CE-IVD marked for extended genotyping, offering the flexibility you need to adapt to changing screening guidelines and evolving patient management guidance.

The approvals cover all three different screening paradigms:

In the post-vaccination era the prevalence of high-risk genotypes may change making it crucial to identify high-risk genotypes individually.

  • Extended genotyping supports risk stratification and persistence monitoring to guide patient management
  • Genotypes 16 and 18 account for 70% of invasive cancer worldwide, but their prevalence is declining as vaccination rates increase.
  • Genotypes 31,33,58 have a CIN3+ risk similar to genotype 18, but 51,35,39,68,56,59,66 have a much lower risk

The BD Onclarity™ HPV Assay has been recently also approved  for use with self-collected vaginal samples which is another milestone to increase screening participation!

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BD Onclarity™ HPV Assay by BD Diagnostics product image

BD Onclarity™ HPV Assay

Manufacturer BD Diagnostics

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