{"slug":"screening-test","tag":"screening-test","variants":["screening-test"],"description":"No description yet","count":18,"kinds":{"drug":18},"related":[{"slug":"test","tag":"test","shared":18}],"records":[{"id":"cobas-hpv","kind":"drug","name":"cobas HPV test (Roche)","route":"/drugs/cobas-hpv/","status":"approved","tldr":"Roche's laboratory test for 14 high-risk HPV types, approved by the FDA for primary cervical screening and, since 2024, for samples women take themselves in a clinic."},{"id":"bd-onclarity-hpv","kind":"drug","name":"BD Onclarity HPV Assay (extended genotyping)","route":"/drugs/bd-onclarity-hpv/","status":"approved","tldr":"BD's laboratory HPV test, approved in 2018, which since 2024 names six high-risk virus types separately, helping decide who needs colposcopy, and accepts samples women take themselves."},{"id":"aptima-hpv","kind":"drug","name":"Aptima HPV Assay and Aptima HPV 16 18/45 Genotype Assay","route":"/drugs/aptima-hpv/","status":"approved","tldr":"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."},{"id":"alinity-m-hr-hpv","kind":"drug","name":"Alinity m HR HPV (Abbott)","route":"/drugs/alinity-m-hr-hpv/","status":"approved","tldr":"Abbott's laboratory HPV test, approved by the FDA in November 2023 for primary cervical screening and in 2025 for self-collected samples taken in a clinic."},{"id":"digene-hc2-hpv","kind":"drug","name":"digene Hybrid Capture 2 (hc2) High-Risk HPV DNA Test","route":"/drugs/digene-hc2-hpv/","status":"approved","tldr":"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."},{"id":"teal-wand","kind":"drug","name":"Teal Wand (home self-collection for HPV screening)","route":"/drugs/teal-wand/","status":"approved","tldr":"The first device the FDA authorised (May 2025) for women to collect their own sample for cervical cancer screening at home, without a clinic visit."},{"id":"thinprep","kind":"drug","name":"ThinPrep Pap Test and ThinPrep processors (Hologic)","route":"/drugs/thinprep/","status":"approved","tldr":"The liquid-based Pap test, approved in 1996, in which cells go into a vial of fluid rather than straight onto a slide; its preservative is the collection medium named in the FDA approvals of several HPV tests."},{"id":"bd-surepath","kind":"drug","name":"BD SurePath liquid-based Pap test and PrepStain slide processor","route":"/drugs/bd-surepath/","status":"approved","tldr":"BD's liquid-based Pap test, approved in 1999 as AutoCyte PREP and renamed SurePath in 2001."},{"id":"automated-pap-screening-readers","kind":"drug","name":"Automated Pap slide readers: BD FocalPoint and the ThinPrep Imaging System","route":"/drugs/automated-pap-screening-readers/","status":"approved","tldr":"Machines that scan Pap slides and point the human reader to the cells most likely to be abnormal, approved in the United States from 1995 onwards."},{"id":"genius-digital-diagnostics","kind":"drug","name":"Genius Digital Diagnostics System with Genius Cervical AI (Hologic)","route":"/drugs/genius-digital-diagnostics/","status":"approved","tldr":"The first FDA-authorised system (January 2024) for reading Pap test slides as digital images with the help of artificial intelligence."},{"id":"cintec-plus-cytology","kind":"drug","name":"CINtec PLUS Cytology (p16/Ki-67 dual stain)","route":"/drugs/cintec-plus-cytology/","status":"approved","tldr":"A stain on cervical cells that helps decide which women with a positive HPV test need colposcopy, approved by the FDA in 2020."},{"id":"prostate-health-index","kind":"drug","name":"Prostate Health Index (phi, Beckman Coulter)","route":"/drugs/prostate-health-index/","status":"approved","tldr":"A blood test that combines three forms of PSA into one score, to help men with a moderately raised PSA and a normal examination decide whether to have a biopsy."},{"id":"4kscore","kind":"drug","name":"4Kscore Test (OPKO Health)","route":"/drugs/4kscore/","status":"approved","tldr":"A blood test that estimates the chance that a biopsy would find an aggressive prostate cancer, approved by the FDA in December 2021 for men 45 and older with an abnormal PSA or examination."},{"id":"isopsa","kind":"drug","name":"IsoPSA Assay (Cleveland Diagnostics)","route":"/drugs/isopsa/","status":"approved","tldr":"A blood test approved by the FDA in November 2025 to help decide on a prostate biopsy in men 50 and older with a PSA between 4 and 10."},{"id":"epi-procolon","kind":"drug","name":"Epi proColon (Septin 9 blood test for bowel cancer)","route":"/drugs/epi-procolon/","status":"approved","tldr":"The first FDA-approved blood test for bowel cancer screening (2016), meant only for people who have been offered and declined the recommended screening tests."},{"id":"oc-sensor-fit","kind":"drug","name":"OC-Sensor faecal immunochemical tests (Eiken, Polymedco)","route":"/drugs/oc-sensor-fit/","status":"approved","tldr":"A family of stool tests for hidden blood and the laboratory machines that read them, cleared by the FDA from 2010 onwards."},{"id":"nevisense","kind":"drug","name":"Nevisense (electrical impedance spectroscopy for melanoma, SciBase)","route":"/drugs/nevisense/","status":"approved","tldr":"A probe that measures the electrical properties of a worrying mole to give a dermatologist more information before deciding on a biopsy, approved by the FDA in 2017."},{"id":"immunocyt","kind":"drug","name":"ImmunoCyt (urine immunocytology for bladder cancer)","route":"/drugs/immunocyt/","status":"approved","tldr":"A urine cell test cleared by the FDA in 2000 for monitoring bladder cancer; with ordinary urine cytology it finds more cancers than cytology alone, at the cost of more false positives."}]}