{"entity":{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","aka":["cobas 4800 HPV Test","cobas HPV Test","cobas HPV for use on the cobas 5800/6800/8800 Systems"],"tldr":"Roche's laboratory test for 14 high-risk HPV types, approved by the FDA for primary cervical screening and, since 2024, for samples women take themselves in a clinic.","summary":"The cobas HPV Test (Roche Molecular Systems) was approved by the FDA on 19 April 2011 (PMA P100020) to detect 14 high-risk HPV types, identifying types 16 and 18 while concurrently detecting the rest (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The version for the cobas 6800/8800 Systems followed on 3 April 2020 (PMA P190028), indicated for routine cervical cancer screening \"including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer\"; a supplement of 19 September 2025 extends it to the cobas 5800 System. On 14 May 2024 the FDA approved testing of self-collected vaginal specimens, obtained in a health-care setting, as an alternative when cervical sampling is contraindicated or cannot be obtained (supplements P100020/S055 and P190028/S009).","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P100020","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P100020"},{"label":"FDA PMA P190028","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190028"}],"tags":["test","screening-test"],"related":["bd-onclarity-hpv","aptima-hpv","alinity-m-hr-hpv","digene-hc2-hpv","cintec-plus-cytology","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":["roche-genentech"],"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":"cobas HPV","modality":"HPV DNA test (PCR) for cervical screening","mechanism":"PCR amplification and hybridisation detect DNA of 14 high-risk HPV types in one run, naming HPV 16 and HPV 18 separately and the other 12 types as a group.","approvals":[{"region":"US","year":2011,"indication":"Detection of 14 high-risk HPV types in cervical specimens (PMA P100020)"},{"region":"US","year":2020,"indication":"cobas 6800/8800 version for routine cervical screening including primary HPV screening (PMA P190028)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2024-05-14","type":"label-change","region":"US","note":"Self-collected vaginal specimens obtained in a health-care setting approved (P190028/S009, P100020/S055)","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190028"}]},"route":"/drugs/cobas-hpv/","neighbours":{"drug":[{"id":"alinity-m-hr-hpv","kind":"drug","name":"Alinity m HR HPV (Abbott)","route":"/drugs/alinity-m-hr-hpv/"},{"id":"aptima-hpv","kind":"drug","name":"Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay","route":"/drugs/aptima-hpv/"},{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","route":"/drugs/bd-onclarity-hpv/"},{"id":"cintec-plus-cytology","kind":"drug","name":"CINtec PLUS Cytology (p16/Ki-67 dual stain)","route":"/drugs/cintec-plus-cytology/"},{"id":"digene-hc2-hpv","kind":"drug","name":"digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test","route":"/drugs/digene-hc2-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":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"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/"}]}}