{"entity":{"id":"mrdx-bcr-abl","kind":"drug","name":"MRDx BCR-ABL Test","aka":[],"tldr":"An FDA-cleared blood test that measures the BCR-ABL1 signal of chronic myeloid leukaemia, listed by the FDA as a companion to nilotinib.","summary":"MolecularMD's MRDx BCR-ABL Test was cleared on 22 December 2017 through the 510(k) route (K173492, decision 'substantially equivalent with drug') and appears on the FDA companion diagnostic list with nilotinib in chronic myeloid leukaemia, tested on peripheral blood. ICON plc announced on 21 February 2019 that it had acquired MolecularMD.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA 510(k) K173492","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173492"},{"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"},{"label":"ICON acquires MolecularMD (21 February 2019)","url":"https://www.iconplc.com/news-events/press-releases/icon-acquires-molecularmd"}],"tags":["test"],"related":["bcr-abl1-transcript"],"cancers":["cml"],"sections":[],"technologies":["companion-diagnostic"],"targets":["bcr-abl"],"drugs":["nilotinib"],"companies":["molecularmd"],"institutions":[],"pathways":[],"terms":["companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"MRDx BCR-ABL Test","modality":"BCR-ABL1 monitoring test (blood)","mechanism":"Measures BCR-ABL1 transcripts in peripheral blood; the FDA classifies it as a Bcr/Abl1 monitoring test.","approvals":[{"region":"US","year":2017,"indication":"510(k) clearance; companion to nilotinib in chronic myeloid leukaemia (peripheral blood)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/mrdx-bcr-abl/","neighbours":{"biomarker":[{"id":"bcr-abl1-transcript","kind":"biomarker","name":"BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR)","route":"/biomarkers/bcr-abl1-transcript/"}],"cancer":[{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"bcr-abl","kind":"target","name":"BCR::ABL1 (Philadelphia chromosome)","route":"/targets/bcr-abl/"}],"drug":[{"id":"nilotinib","kind":"drug","name":"Nilotinib","route":"/drugs/nilotinib/"}],"company":[{"id":"molecularmd","kind":"company","name":"MolecularMD","route":"/companies/molecularmd/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"}]}}