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A stain on cervical cells that helps decide which women with a positive HPV test need colposcopy, approved by the FDA in 2020.
CINtec PLUS Cytology (Ventana Medical Systems, Roche Diagnostics) was approved by the FDA on 10 March 2020 (PMA P190024). It detects p16INK4a and Ki-67 together in cervical specimens in ThinPrep PreservCyt solution, using a mouse monoclonal antibody against p16 (clone E6H4) and a rabbit monoclonal antibody against Ki-67 (clone 274-11AC3V1) on the BenchMark ULTRA instrument. It is indicated in women aged 25 to 65 whose cobas 4800 HPV primary screening test is positive for the 12 other high-risk types, to decide on referral to colposcopy, and for women positive for HPV 16/18; and in women aged 30 to 65 with normal cytology (NILM) and a positive HPV result in co-testing. Results are interpreted by a pathologist.
Two antibodies detect the proteins p16INK4a and Ki-67 together in the same cervical cells, read by a pathologist.
| Region | Year | Indication |
|---|---|---|
| US | 2020 | Triage of HPV-positive cervical screening results (cobas 4800) to decide on colposcopy (PMA P190024) |
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Query for this drug: (TITLE:"CINtec PLUS Cytology" OR ABSTRACT:"CINtec PLUS Cytology" OR TITLE:"p16/Ki-67 dual stain" OR ABSTRACT:"p16/Ki-67 dual stain" OR TITLE:"CINtec PLUS" OR ABSTRACT:"CINtec PLUS" OR TITLE:"dual stain cytology" OR ABSTRACT:"dual stain cytology") 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 CINtec PLUS Cytology (p16/Ki-67 dual stain), 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 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.
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