{"entity":{"id":"cintec-plus-cytology","kind":"drug","name":"CINtec PLUS Cytology (p16/Ki-67 dual stain)","aka":["p16/Ki-67 dual stain","dual stain cytology"],"tldr":"A stain on cervical cells that helps decide which women with a positive HPV test need colposcopy, approved by the FDA in 2020.","summary":"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.","status":"approved","asOf":"2026-11-04","links":[{"label":"FDA PMA P190024","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P190024"}],"tags":["test","screening-test"],"related":["cobas-hpv","thinprep","fda-device-databases"],"cancers":["cervical"],"sections":["early-detection","diagnostics"],"technologies":["hpv-testing"],"targets":[],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":["cin-hsil","screening","ihc"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"CINtec PLUS","modality":"Immunocytochemistry dual-stain test for triage of HPV-positive screens","mechanism":"Two antibodies detect the proteins p16INK4a and Ki-67 together in the same cervical cells, read by a pathologist.","approvals":[{"region":"US","year":2020,"indication":"Triage of HPV-positive cervical screening results (cobas 4800) to decide on colposcopy (PMA P190024)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cintec-plus-cytology/","neighbours":{"drug":[{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/"},{"id":"thinprep","kind":"drug","name":"ThinPrep Pap Test and ThinPrep processors (Hologic)","route":"/drugs/thinprep/"}],"collection":[{"id":"fda-device-databases","kind":"collection","name":"FDA medical device databases (PMA, 510(k), De Novo)","route":"/collections/fda-device-databases/"}],"cancer":[{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"}],"section":[{"id":"diagnostics","kind":"section","name":"Diagnostics & Biomarkers","route":"/fronts/diagnostics/"},{"id":"early-detection","kind":"section","name":"Early Detection & Screening","route":"/fronts/early-detection/"}],"technology":[{"id":"hpv-testing","kind":"technology","name":"HPV DNA testing and self-sampling","route":"/technologies/hpv-testing/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"term":[{"id":"cin-hsil","kind":"term","name":"Cervical precancer (CIN, HSIL/LSIL)","route":"/terms/cin-hsil/"},{"id":"ihc","kind":"term","name":"Immunohistochemistry (IHC)","route":"/terms/ihc/"},{"id":"screening","kind":"term","name":"Screening","route":"/terms/screening/"}]}}