{"entity":{"id":"tempus-xt-cdx","kind":"drug","name":"Tempus xT CDx","aka":[],"tldr":"Tempus's tumour-and-normal gene panel, FDA-approved in 2023 as a companion test for EGFR antibodies in bowel cancer.","summary":"The FDA approved Tempus xT CDx in 2023 as a 648-gene tumour-normal panel with a companion diagnostic claim for KRAS and NRAS wild-type colorectal cancer (cetuximab and panitumumab eligibility) and with tumour-profiling claims across solid tumours. The matched-normal design distinguishes inherited variants from tumour-acquired ones and reduces false positives. Tempus pairs the test with its multimodal database and trial-matching software, which is the company's commercial thesis: the test is the entry point to data.","status":"approved","asOf":"2026-09-10","links":[{"label":"Tempus: xT CDx","url":"https://www.tempus.com/oncology/genomic-profiling/xt-cdx/"}],"tags":["test"],"related":[],"cancers":["colorectal","pancreatic"],"sections":[],"technologies":["cgp","companion-diagnostic"],"targets":["kras","egfr"],"drugs":["cetuximab","panitumumab"],"companies":["tempus"],"institutions":[],"pathways":[],"terms":["ngs","germline-vs-somatic"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017"],"journals":[],"dependsOn":[],"notes":["What a result means: a RAS mutation rules out EGFR antibodies in bowel cancer; other findings feed treatment and trial options."],"brand":"xT CDx","modality":"Tissue NGS companion diagnostic test (648 genes, tumour-normal)","mechanism":"Hybrid-capture sequencing of 648 genes in tumour tissue with matched normal blood or saliva to separate somatic from germline variants; reports MSI status and companion claims.","approvals":[{"region":"US","year":2023,"indication":"Companion diagnostic for cetuximab and panitumumab (KRAS/NRAS wild-type colorectal cancer) with tumour-profiling claims"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/tempus-xt-cdx/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"},{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"kras","kind":"target","name":"KRAS","route":"/targets/kras/"},{"id":"nras","kind":"target","name":"NRAS","route":"/targets/nras/"}],"drug":[{"id":"cetuximab","kind":"drug","name":"Cetuximab","route":"/drugs/cetuximab/"},{"id":"panitumumab","kind":"drug","name":"Panitumumab","route":"/drugs/panitumumab/"}],"company":[{"id":"tempus","kind":"company","name":"Tempus AI","route":"/companies/tempus/"}],"term":[{"id":"germline-vs-somatic","kind":"term","name":"Germline vs somatic mutations","route":"/terms/germline-vs-somatic/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}],"paper":[{"id":"paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017","kind":"paper","name":"Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO","route":"/key-papers/paper-sepulveda-molecular-biomarkers-colorectal-guideline-jco-2017/"}],"biomarker":[{"id":"ras-wild-type","kind":"biomarker","name":"RAS wild-type (extended KRAS and NRAS testing)","route":"/biomarkers/ras-wild-type/"}],"roadmap":[{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}]}}