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Qiagen's hybrid capture HPV test, approved by the FDA in 2003 for use with the Pap test in women 30 and older and for sorting out borderline Pap results.
The hybrid capture HPV test sits under PMA P890064, first approved on 11 March 1991 as the ViraType HPV DNA typing kit (now held by Qiagen Gaithersburg). The Digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test was approved on 31 March 2003 (supplement S009) for two uses: to screen patients with ASCUS Pap results to decide on referral to colposcopy, and "in women 30 years and older" to be used "with Pap to adjunctively screen to assess the presence or absence of high-risk HPV types".
HPV DNA in the sample forms RNA:DNA hybrids with the test's probes; the hybrids are captured on a microtitre plate and detected (the capture step described in supplement S006).
hc2 High-Risk HPV DNA Test approved for adjunctive screening with Pap in women 30 and older (P890064/S009) source
| Region | Year | Indication |
|---|---|---|
| US | 1991 | ViraType HPV DNA typing kit, the original approval of PMA P890064 under which the hybrid capture tests followed |
| US | 2003 | High-risk HPV DNA test on cervical specimens: ASCUS triage and adjunctive screening with the Pap test in women 30 and older (PMA P890064/S009) |
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Query for this drug: (TITLE:"digene Hybrid Capture 2 hc2 High-Risk HPV DNA Test" OR ABSTRACT:"digene Hybrid Capture 2 hc2 High-Risk HPV DNA Test" OR TITLE:"hc2 High-Risk HPV DNA Test" OR ABSTRACT:"hc2 High-Risk HPV DNA Test" OR TITLE:"Hybrid Capture 2" OR ABSTRACT:"Hybrid Capture 2" OR TITLE:"hc2" OR ABSTRACT:"hc2" OR TITLE:"Digene HPV test" OR ABSTRACT:"Digene HPV test" OR TITLE:"HCII" OR ABSTRACT:"HCII") 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 digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test, not a curated reading list.
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), 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 Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay, 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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