{"entity":{"id":"crcdx-ras","kind":"drug","name":"CRCDx RAS Mutation Detection Assay Kit","aka":[],"tldr":"A PCR test that confirms a bowel cancer has no KRAS or NRAS mutation before panitumumab.","summary":"EntroGen's CRCDx RAS Mutation Detection Assay Kit was approved on 29 September 2023 (PMA P220005) as the companion diagnostic for panitumumab in colorectal cancer, identifying tumours wild-type for KRAS and NRAS in exons 2, 3 and 4. EntroGen describes it as a real-time PCR test.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P220005","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P220005"},{"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":"EntroGen: CRCdx RAS Mutation Detection","url":"https://www.entrogen.com/"}],"tags":["test"],"related":["ras-wild-type"],"cancers":["colorectal"],"sections":[],"technologies":["companion-diagnostic"],"targets":["kras","nras"],"drugs":["panitumumab"],"companies":["entrogen"],"institutions":[],"pathways":[],"terms":["pcr","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"CRCdx RAS Mutation Detection","modality":"Real-time PCR companion diagnostic test (KRAS and NRAS, colorectal tumour tissue)","mechanism":"Real-time PCR for mutations in exons 2, 3 and 4 of KRAS and NRAS in colorectal tumour tissue; a RAS wild-type result means none were found.","approvals":[{"region":"US","year":2023,"indication":"KRAS and NRAS wild-type (exons 2, 3 and 4) for panitumumab in colorectal cancer"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/crcdx-ras/","neighbours":{"biomarker":[{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"nras","kind":"target","name":"NRAS","route":"/targets/nras/"}],"drug":[{"id":"panitumumab","kind":"drug","name":"Panitumumab","route":"/drugs/panitumumab/"}],"company":[{"id":"entrogen","kind":"company","name":"EntroGen","route":"/companies/entrogen/"}],"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/"}]}}