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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.
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.
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.
Extended genotyping (16, 18, 31, 45, 51, 52 and three groups) and self-collected vaginal specimens (P160037/S017) source
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Detection of 14 high-risk HPV types in cervical specimens (PMA P160037) |
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Query for this drug: (TITLE:"BD Onclarity HPV Assay" OR ABSTRACT:"BD Onclarity HPV Assay" OR TITLE:"extended genotyping" OR ABSTRACT:"extended genotyping" OR TITLE:"BD Onclarity HPV" OR ABSTRACT:"BD Onclarity HPV" OR TITLE:"Onclarity HPV" OR ABSTRACT:"Onclarity HPV" OR TITLE:"BD Onclarity" OR ABSTRACT:"BD Onclarity") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about BD Onclarity HPV Assay (extended genotyping), not a curated reading list.
Shares BD SurePath liquid-based Pap test and PrepStain slide processor, BD (Becton, Dickinson and Company), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL) and the tags test, screening-test.
Shares cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares BD SurePath liquid-based Pap test and PrepStain slide processor, FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening, Cervical cancer and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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