# Haystack MRD

Source: https://onco.cc/drugs/haystack-mrd/  
OnCo record `haystack-mrd` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Test
- Status: emerging
- Last checked: 2026-11-03
- Tags: test
- 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.

## 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.

## Sources

- Haystack MRD: https://haystackmrd.com/
- Haystack MRD for clinicians: https://haystackmrd.com/clinicians/
- Quest Diagnostics: FDA Breakthrough Device designation for Haystack MRD (25 August 2025): https://haystackmrd.com/fda-grants-breakthrough-device-designation-for-haystack-mrd-circulating-tumor-dna-test-from-quest-diagnostics/
- Haystack MRD receives New York State approval (June 2026): https://haystackmrd.com/haystack-mrd-receives-new-york-state-approval/
- Quest Diagnostics completes acquisition of Haystack Oncology (21 June 2023): https://newsroom.questdiagnostics.com/2023-06-21-Quest-Diagnostics-Completes-Acquisition-of-Haystack-Oncology,-Adding-Sensitive-MRD-Liquid-Biopsy-Technology-to-Cancer-Diagnostics-Portfolio

## Connected records

- drugs: [Labcorp Plasma Detect](https://onco.cc/drugs/labcorp-plasma-detect/), [RaDaR ST](https://onco.cc/drugs/radar-mrd/), [Signatera](https://onco.cc/drugs/signatera/)
- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/), [Whole-exome & whole-genome sequencing](https://onco.cc/technologies/wes-wgs/)
- companies: [Haystack Oncology](https://onco.cc/companies/haystack-oncology/), [Quest Diagnostics](https://onco.cc/companies/quest-diagnostics/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Minimal / molecular residual disease (MRD)](https://onco.cc/terms/mrd/), [Tumour-informed versus tumour-naive ctDNA assays](https://onco.cc/terms/tumour-informed-assay/)
- trials: [DYNAMIC](https://onco.cc/trials/dynamic/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)
- biomarkers: [ctDNA MRD positivity (molecular residual disease after curative treatment)](https://onco.cc/biomarkers/ctdna-mrd-positive/)

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