{"entity":{"id":"haystack-mrd","kind":"drug","name":"Haystack MRD","aka":[],"tldr":"Quest Diagnostics' blood test for leftover cancer after surgery, with an FDA Breakthrough Device designation in stage II bowel cancer.","summary":"Haystack MRD comes from Haystack Oncology of Baltimore, which Quest Diagnostics acquired on 21 June 2023. Quest introduced it as a laboratory-developed test in late 2024. It sequences the tumour's exome to choose up to 50 variants and states that it detects 95% of cases at a tumour fraction of 0.0006% (company data on file). On 25 August 2025 the FDA granted Breakthrough Device designation for identifying MRD-positive patients with stage II colorectal cancer after curative-intent surgery who may benefit from adjuvant therapy, and New York State approved it in June 2026 for residual or recurring disease in solid tumours. The chemistry descends from Safe-SeqS, the method used in the DYNAMIC trial of ctDNA-guided adjuvant chemotherapy in stage II colon cancer.","status":"emerging","asOf":"2026-11-03","links":[{"label":"Haystack MRD","url":"https://haystackmrd.com/"},{"label":"Haystack MRD for clinicians","url":"https://haystackmrd.com/clinicians/"},{"label":"Quest Diagnostics: FDA Breakthrough Device designation for Haystack MRD (25 August 2025)","url":"https://haystackmrd.com/fda-grants-breakthrough-device-designation-for-haystack-mrd-circulating-tumor-dna-test-from-quest-diagnostics/"},{"label":"Haystack MRD receives New York State approval (June 2026)","url":"https://haystackmrd.com/haystack-mrd-receives-new-york-state-approval/"},{"label":"Quest Diagnostics completes acquisition of Haystack Oncology (21 June 2023)","url":"https://newsroom.questdiagnostics.com/2023-06-21-Quest-Diagnostics-Completes-Acquisition-of-Haystack-Oncology,-Adding-Sensitive-MRD-Liquid-Biopsy-Technology-to-Cancer-Diagnostics-Portfolio"}],"tags":["test"],"related":["signatera","radar-mrd"],"cancers":["colorectal"],"sections":[],"technologies":["mrd-testing","liquid-biopsy","wes-wgs"],"targets":[],"drugs":[],"companies":["haystack-oncology","quest-diagnostics"],"institutions":[],"pathways":[],"terms":["mrd","ctdna","tumour-informed-assay"],"trials":["dynamic"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: the same as other tumour-informed MRD tests; ask whether a positive result would change your treatment before having it.","Not confirmed: Medicare coverage. On 3 November 2026 the company's FAQ said it was working with CMS on coverage, and the MolDX billing article A58376 does not list it. DYNAMIC used the predecessor Safe-SeqS method, not the current assay."],"brand":"Haystack MRD","modality":"Tumour-informed ctDNA minimal residual disease test (up to 50 variants)","mechanism":"Whole-exome sequencing of tumour tissue and a matched normal blood sample designs a personalised panel of up to 50 variants, which is tracked in plasma.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/haystack-mrd/","neighbours":{"drug":[{"id":"labcorp-plasma-detect","kind":"drug","name":"Labcorp Plasma Detect","route":"/drugs/labcorp-plasma-detect/"},{"id":"radar-mrd","kind":"drug","name":"RaDaR ST","route":"/drugs/radar-mrd/"},{"id":"signatera","kind":"drug","name":"Signatera","route":"/drugs/signatera/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"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":"haystack-oncology","kind":"company","name":"Haystack Oncology","route":"/companies/haystack-oncology/"},{"id":"quest-diagnostics","kind":"company","name":"Quest Diagnostics","route":"/companies/quest-diagnostics/"}],"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/"}],"trial":[{"id":"dynamic","kind":"trial","name":"DYNAMIC","route":"/trials/dynamic/"}],"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/"}]}}