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An HPV test that detects the virus's E6/E7 messenger RNA rather than its DNA, approved by the FDA in 2011, with a follow-on test that names types 16, 18 and 45.
The Aptima HPV Assay (applicant Gen-Probe Incorporated) was approved by the FDA on 28 October 2011 (PMA P100042) for the qualitative detection of E6/E7 viral messenger RNA from 14 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) in cervical specimens in ThinPrep vials, without distinguishing between them. The Aptima HPV 16 18/45 Genotype Assay (PMA P120007, 12 October 2012) tests specimens positive on the first assay and differentiates HPV 16 from HPV 18 and/or 45, but not HPV 18 from HPV 45. Both were first indicated for triage of ASC-US cytology in patients aged 21 and older, among other uses listed in the approval orders.
Nucleic acid amplification detects E6/E7 messenger RNA from 14 high-risk HPV types; a reflex genotype assay separates HPV 16 from HPV 18 and 45.
| Region | Year | Indication |
|---|---|---|
| US | 2011 | E6/E7 mRNA detection of 14 high-risk HPV types in cervical specimens (PMA P100042) |
| US | 2012 | HPV 16 and 18/45 genotyping of Aptima HPV-positive specimens (PMA P120007) |
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Query for this drug: (TITLE:"Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay" OR ABSTRACT:"Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay" OR TITLE:"Aptima HPV" OR ABSTRACT:"Aptima HPV" OR TITLE:"Aptima HPV 16 18/45" OR ABSTRACT:"Aptima HPV 16 18/45") 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 Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay, not a curated reading list.
Shares ThinPrep Pap Test and ThinPrep processors (Hologic), cobas HPV test (Roche), FDA medical device databases (PMA, 510(k), De Novo), Cervical precancer (CIN, HSIL/LSIL) 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 ThinPrep Pap Test and ThinPrep processors (Hologic), 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 ThinPrep Pap Test and ThinPrep processors (Hologic), 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), HPV DNA testing and self-sampling, Screening 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 ThinPrep Pap Test and ThinPrep processors (Hologic), FDA medical device databases (PMA, 510(k), De Novo), HPV DNA testing and self-sampling, Screening and the tags test, screening-test.
Shares FDA medical device databases (PMA, 510(k), De Novo), Screening and the tags test, screening-test.
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