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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.
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.
Detects DNA of high-risk HPV types, naming 16, 18 and 45 and reporting the others in two groups.
Self-collected vaginal specimens obtained in a health-care setting (P230003/S006) source
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Routine cervical screening including primary HPV screening (PMA P230003) |
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Query for this drug: (TITLE:"Alinity m HR HPV" OR ABSTRACT:"Alinity m HR HPV" OR TITLE:"Abbott" OR ABSTRACT:"Abbott") 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 Alinity m HR HPV (Abbott), not a curated reading list.
Shares BD Onclarity HPV Assay (extended genotyping), cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), 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 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 Onclarity HPV Assay (extended genotyping), 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), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL), HPV DNA testing and self-sampling, Screening 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.
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