{"entity":{"id":"abbott-realtime-idh2","kind":"drug","name":"Abbott RealTime IDH2","aka":[],"tldr":"The FDA-approved test that finds an IDH2 mutation in acute myeloid leukaemia, the gateway to enasidenib.","summary":"Abbott Molecular's RealTime IDH2 was approved on 1 August 2017 (PMA P170005) as the companion diagnostic for enasidenib in acute myeloid leukaemia. It reads blood or bone marrow.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P170005","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170005"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["abbott-realtime-idh1","idh2-mutation"],"cancers":["aml"],"sections":[],"technologies":["companion-diagnostic"],"targets":["idh"],"drugs":["enasidenib"],"companies":["abbott"],"institutions":[],"pathways":[],"terms":["pcr","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Abbott RealTime IDH2","modality":"PCR companion diagnostic test (IDH2 mutations, blood or bone marrow)","mechanism":"Detects the IDH2 mutations R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S and R172W in DNA from peripheral blood or bone marrow.","approvals":[{"region":"US","year":2017,"indication":"Companion diagnostic for enasidenib in acute myeloid leukaemia (IDH2 R140 and R172 mutations)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/abbott-realtime-idh2/","neighbours":{"drug":[{"id":"abbott-realtime-idh1","kind":"drug","name":"Abbott RealTime IDH1","route":"/drugs/abbott-realtime-idh1/"},{"id":"enasidenib","kind":"drug","name":"Enasidenib","route":"/drugs/enasidenib/"}],"biomarker":[{"id":"idh2-mutation","kind":"biomarker","name":"IDH2 mutation (R140 and R172)","route":"/biomarkers/idh2-mutation/"}],"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"idh","kind":"target","name":"IDH1 / IDH2","route":"/targets/idh/"}],"company":[{"id":"abbott","kind":"company","name":"Abbott Laboratories","route":"/companies/abbott/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}]}}