- Device
- APTIMA HPV ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100042
- Supplement
- S038
- Product code
- OYB
- Generic name
- Kit, rna detection, human papillomavirus
- Decision date
- 2026-02-03
- Decision code
- APPR
- Date received
- 2025-05-08
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- The Aptima HPV Assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The Aptima HPV Assay does not differentiate between the 14 high-risk types. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt® Solution and collected with broom-type or cytobrush/spatula collection devices* may be tested with the Aptima HPV Assay. The assay is used with the Tigris DTS System or the Panther System.The Aptima HPV Assay is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (adjunctive screening) with cytology, and HPV primary screening of women to assess the risk for cervical pre-cancer and cancer. Patients should be followed-up in accordance with professional medical guidelines, results from prior screening, medical history, and other risk factors.Primary HPV screening with the Aptima HPV Assay has only been validated on the Panther System.