# Alinity m HR HPV (Abbott)

Source: https://onco.cc/drugs/alinity-m-hr-hpv/  
OnCo record `alinity-m-hr-hpv` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-04
- Tags: test; screening-test
- 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: US 2023: Routine cervical screening including primary HPV screening (PMA P230003)

## 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.

## Sources

- FDA PMA P230003: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P230003

## Connected records

- drugs: [BD Onclarity HPV Assay (extended genotyping)](https://onco.cc/drugs/bd-onclarity-hpv/), [cobas HPV test (Roche)](https://onco.cc/drugs/cobas-hpv/)
- collections: [FDA medical device databases (PMA, 510(k), De Novo)](https://onco.cc/collections/fda-device-databases/)
- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/), [Early Detection & Screening](https://onco.cc/fronts/early-detection/)
- technologies: [HPV DNA testing and self-sampling](https://onco.cc/technologies/hpv-testing/)
- companies: [Abbott Laboratories](https://onco.cc/companies/abbott/)
- terms: [Cervical precancer (CIN, HSIL/LSIL)](https://onco.cc/terms/cin-hsil/), [Screening](https://onco.cc/terms/screening/)

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