# BD Onclarity HPV Assay (extended genotyping)

Source: https://onco.cc/drugs/bd-onclarity-hpv/  
OnCo record `bd-onclarity-hpv` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

BD's laboratory HPV test, approved in 2018, which since 2024 names six high-risk virus types separately, helping decide who needs colposcopy, and accepts samples women take themselves.

## Summary

The BD Onclarity HPV Assay (Becton, Dickinson and Company) was approved by the FDA on 12 February 2018 (PMA P160037) to detect 14 high-risk HPV types in cervical specimens collected in BD SurePath vials, identifying types 16, 18 and 45. A panel-track supplement of 14 May 2024 (S017) extended the genotyping to identify types 16, 18, 31, 45, 51 and 52 individually and to report the others in groups (33/58, 35/39/68 and 56/59/66), added ThinPrep PreservCyt specimens and approved self-collected vaginal specimens. Supplements of 2 April 2026 and 14 August 2026 expanded the settings for self-collection and its transport and storage conditions.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Also known as: Onclarity HPV; BD Onclarity
- Tags: test; screening-test
- Brand: BD Onclarity HPV
- Modality: HPV DNA test (PCR) with extended genotyping, for cervical screening
- Mechanism: PCR amplification and hybridisation detect DNA of 14 high-risk HPV types; the current version names six types individually and reports the rest in three groups.
- Approvals: US 2018: Detection of 14 high-risk HPV types in cervical specimens (PMA P160037)

## Notes

- What a result means: a positive HPV test means a high-risk virus type was found, not that there is a precancer or cancer; it leads to triage (genotyping, cytology or a dual stain) or colposcopy according to the screening programme's guideline.

## Sources

- FDA PMA P160037: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160037

## Connected records

- drugs: [Alinity m HR HPV (Abbott)](https://onco.cc/drugs/alinity-m-hr-hpv/), [BD SurePath liquid-based Pap test and PrepStain slide processor](https://onco.cc/drugs/bd-surepath/), [cobas HPV test (Roche)](https://onco.cc/drugs/cobas-hpv/), [Teal Wand (home self-collection for HPV screening)](https://onco.cc/drugs/teal-wand/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [HPV DNA testing and self-sampling](https://onco.cc/technologies/hpv-testing/)
- companies: [BD (Becton, Dickinson and Company)](https://onco.cc/companies/becton-dickinson/)
- terms: [Cervical precancer (CIN, HSIL/LSIL)](https://onco.cc/terms/cin-hsil/), [Screening](https://onco.cc/terms/screening/)

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