{"entity":{"id":"aptima-hpv","kind":"drug","name":"Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay","aka":["Aptima HPV 16 18/45"],"tldr":"An HPV test that detects the virus's E6/E7 messenger RNA rather than its DNA, approved by the FDA in 2011, with a follow-on test that names types 16, 18 and 45.","summary":"The Aptima HPV Assay (applicant Gen-Probe Incorporated) was approved by the FDA on 28 October 2011 (PMA P100042) for the qualitative detection of E6/E7 viral messenger RNA from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) in cervical specimens in ThinPrep vials, without distinguishing between them. The Aptima HPV 16 18/45 Genotype Assay (PMA P120007, 12 October 2012) tests specimens positive on the first assay and differentiates HPV 16 from HPV 18 and/or 45, but not HPV 18 from HPV 45. Both were first indicated for triage of ASC-US cytology in patients aged 21 and older, among other uses listed in the approval orders.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P100042","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100042"},{"label":"FDA PMA P120007","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P120007"}],"tags":["test","screening-test"],"related":["cobas-hpv","thinprep","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":[],"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":"Aptima HPV","modality":"HPV messenger RNA test for cervical screening","mechanism":"Nucleic acid amplification detects E6/E7 messenger RNA from 14 high-risk HPV types; a reflex genotype assay separates HPV 16 from HPV 18 and 45.","approvals":[{"region":"US","year":2011,"indication":"E6/E7 mRNA detection of 14 high-risk HPV types in cervical specimens (PMA P100042)"},{"region":"US","year":2012,"indication":"HPV 16 and 18/45 genotyping of Aptima HPV-positive specimens (PMA P120007)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/aptima-hpv/","neighbours":{"drug":[{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/"},{"id":"digene-hc2-hpv","kind":"drug","name":"digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test","route":"/drugs/digene-hc2-hpv/"},{"id":"thinprep","kind":"drug","name":"ThinPrep Pap Test and ThinPrep processors (Hologic)","route":"/drugs/thinprep/"}],"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/"}],"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/"}]}}