{"entity":{"id":"truemrd","kind":"drug","name":"TrueMRD","aka":["Veracyte TrueMRD","TrueMRD Monitoring Test"],"tldr":"Veracyte's whole-genome blood test for bladder cancer coming back after treatment, built on C2i Genomics' method and Medicare-covered from launch in June 2026.","summary":"TrueMRD is Veracyte's first residual disease test, built on the whole-genome approach of C2i Genomics, which Veracyte acquired in February 2024. On 15 May 2026 Veracyte announced Medicare MolDX coverage of the TrueMRD Monitoring Test for recurrence monitoring after definitive treatment with curative intent in muscle-invasive bladder cancer, with ordering from 1 June 2026. The validation study it cites is PAGER, a prospective study of tumour-informed whole-genome ctDNA detection in urothelial carcinoma (European Urology 2024).","status":"emerging","asOf":"2026-11-03","links":[{"label":"Veracyte: TrueMRD in muscle-invasive bladder cancer","url":"https://www.veracyte.com/tests/truemrd-mibc/"},{"label":"Veracyte secures Medicare coverage for TrueMRD (15 May 2026, archived copy)","url":"http://web.archive.org/web/20260515145710/https://investor.veracyte.com/news-releases/news-release-details/veracyte-secures-medicare-coverage-truemrd-monitoring-test"},{"label":"Veracyte completes acquisition of C2i Genomics (6 February 2024, archived copy)","url":"http://web.archive.org/web/20250813165011/https://investor.veracyte.com/news-releases/news-release-details/veracyte-completes-acquisition-c2i-genomics"},{"label":"PAGER: whole-genome tumour-informed ctDNA in urothelial carcinoma (European Urology 2024)","url":"https://doi.org/10.1016/j.eururo.2024.05.014"},{"label":"CMS MolDX billing article A58376: minimal residual disease testing for solid tumour cancers","url":"https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58376"}],"tags":["test"],"related":["signatera"],"cancers":["muscle-invasive-bladder-cancer","urothelial"],"sections":[],"technologies":["mrd-testing","liquid-biopsy","wes-wgs"],"targets":[],"drugs":[],"companies":["veracyte","c2i-genomics"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","tumour-informed-assay"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a positive result after cystectomy or other curative treatment suggests the bladder cancer is returning; acting on it is being studied, and in a related setting a positive Signatera result now selects patients for adjuvant atezolizumab.","Not confirmed: the number of variants tracked and any FDA designation. Veracyte's own site refused automated reading on 3 November 2026; the coverage release was read from an archived copy of 15 May 2026."],"brand":"TrueMRD","modality":"Tumour-informed whole-genome ctDNA minimal residual disease test","mechanism":"Whole-genome sequencing of the tumour identifies patient-specific variants across the genome, which are then looked for genome-wide in each plasma sample rather than in a small targeted panel.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[{"country":"US","reimbursement":"Medicare (MolDX) covers the TrueMRD Monitoring Test for recurrence monitoring after definitive treatment with curative intent in muscle-invasive bladder cancer (announced 15 May 2026)","source":"http://web.archive.org/web/20260515145710/https://investor.veracyte.com/news-releases/news-release-details/veracyte-secures-medicare-coverage-truemrd-monitoring-test","asOf":"2026-11-03"}],"regulatoryEvents":[]},"route":"/drugs/truemrd/","neighbours":{"drug":[{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"}],"cancer":[{"id":"urothelial","kind":"cancer","name":"Bladder & urothelial cancer","route":"/cancers/urothelial/"},{"id":"muscle-invasive-bladder-cancer","kind":"cancer","name":"Muscle-invasive and advanced bladder cancer","route":"/cancers/muscle-invasive-bladder-cancer/"}],"technology":[{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"},{"id":"wes-wgs","kind":"technology","name":"Whole-exome & whole-genome sequencing","route":"/technologies/wes-wgs/"}],"company":[{"id":"c2i-genomics","kind":"company","name":"C2i Genomics","route":"/companies/c2i-genomics/"},{"id":"veracyte","kind":"company","name":"Veracyte (Decipher)","route":"/companies/veracyte/"}],"term":[{"id":"ctdna","kind":"term","name":"Circulating tumour DNA (ctDNA)","route":"/terms/ctdna/"},{"id":"mrd","kind":"term","name":"Minimal / molecular residual disease (MRD)","route":"/terms/mrd/"},{"id":"tumour-informed-assay","kind":"term","name":"Tumour-informed versus tumour-naive ctDNA assays","route":"/terms/tumour-informed-assay/"}],"roadmap":[{"id":"ctdna-tests","kind":"roadmap","name":"ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment","route":"/roadmaps/ctdna-tests/"},{"id":"diagnostics-roadmap","kind":"roadmap","name":"Diagnostics roadmap: stains → gene panels → blood tests that decide treatment","route":"/roadmaps/diagnostics-roadmap/"}],"biomarker":[{"id":"ctdna-mrd-positive","kind":"biomarker","name":"ctDNA MRD positivity (molecular residual disease after curative treatment)","route":"/biomarkers/ctdna-mrd-positive/"}]}}