{"entity":{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","aka":["Onclarity HPV","BD Onclarity"],"tldr":"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.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P160037","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160037"}],"tags":["test","screening-test"],"related":["cobas-hpv","bd-surepath","alinity-m-hr-hpv","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":["becton-dickinson"],"institutions":[],"pathways":[],"terms":["cin-hsil","screening"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"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."],"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":[{"region":"US","year":2018,"indication":"Detection of 14 high-risk HPV types in cervical specimens (PMA P160037)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2024-05-14","type":"label-change","region":"US","note":"Extended genotyping (16, 18, 31, 45, 51, 52 and three groups) and self-collected vaginal specimens (P160037/S017)","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160037"}]},"route":"/drugs/bd-onclarity-hpv/","neighbours":{"drug":[{"id":"alinity-m-hr-hpv","kind":"drug","name":"Alinity m HR HPV (Abbott)","route":"/drugs/alinity-m-hr-hpv/"},{"id":"bd-surepath","kind":"drug","name":"BD SurePath liquid-based Pap test and PrepStain slide processor","route":"/drugs/bd-surepath/"},{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/"},{"id":"teal-wand","kind":"drug","name":"Teal Wand (home self-collection for HPV screening)","route":"/drugs/teal-wand/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"hpv-testing","kind":"technology","name":"HPV DNA testing and self-sampling","route":"/technologies/hpv-testing/"}],"company":[{"id":"becton-dickinson","kind":"company","name":"BD (Becton, Dickinson and Company)","route":"/companies/becton-dickinson/"}],"term":[{"id":"cin-hsil","kind":"term","name":"Cervical precancer (CIN, HSIL/LSIL)","route":"/terms/cin-hsil/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}