{"entity":{"id":"alinity-m-hr-hpv","kind":"drug","name":"Alinity m HR HPV (Abbott)","aka":[],"tldr":"Abbott's laboratory HPV test, approved by the FDA in November 2023 for primary cervical screening and in 2025 for self-collected samples taken in a clinic.","summary":"Alinity m HR HPV (Abbott Molecular) was approved by the FDA on 1 November 2023 (PMA P230003) to detect HPV DNA in clinician-collected cervical specimens in ThinPrep PreservCyt solution or SurePath preservative fluid. It identifies types 16, 18 and 45 and reports the other high-risk genotypes in two groups (31/33/52/58 and 35/39/51/56/59/66/68), and is indicated for routine cervical screening including triage of ASC-US cytology, co-testing with cytology and primary HPV screening. A supplement of 10 September 2025 (S006) added self-collected vaginal specimens obtained in a health-care setting, when cervical sampling is contraindicated or cannot be obtained.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P230003","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230003"}],"tags":["test","screening-test"],"related":["cobas-hpv","bd-onclarity-hpv","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":["abbott"],"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":"Alinity m HR HPV","modality":"HPV DNA test for cervical screening","mechanism":"Detects DNA of high-risk HPV types, naming 16, 18 and 45 and reporting the others in two groups.","approvals":[{"region":"US","year":2023,"indication":"Routine cervical screening including primary HPV screening (PMA P230003)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-09-10","type":"label-change","region":"US","note":"Self-collected vaginal specimens obtained in a health-care setting (P230003/S006)","source":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230003"}]},"route":"/drugs/alinity-m-hr-hpv/","neighbours":{"drug":[{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","route":"/drugs/bd-onclarity-hpv/"},{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/"}],"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":"abbott","kind":"company","name":"Abbott Laboratories","route":"/companies/abbott/"}],"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/"}]}}