Quest Diagnostics' MRD Test Gains Validation in City of Hope Trial
Event summary
- Quest Diagnostics' Haystack MRD® ctDNA minimal residual disease test is being evaluated in a multi-year research program at City of Hope, involving approximately 500 patients across 14 sites.
- The research will focus on breast, colorectal, ovarian, and prostate cancer patients, assessing the test's ability to detect minimal residual disease and monitor treatment response.
- City of Hope's research will investigate Haystack MRD across neoadjuvant, adjuvant, and post-treatment surveillance settings.
- Haystack MRD received Breakthrough Device Designation from the FDA in 2025 for use in Stage II colorectal cancer.
The big picture
The collaboration highlights the growing trend of integrating liquid biopsy into cancer management, moving beyond traditional imaging for disease monitoring. While promising, the adoption of ctDNA MRD testing faces hurdles including cost, reimbursement, and the need for robust clinical validation across diverse cancer types. Quest Diagnostics' acquisition of Haystack Oncology positions them to capitalize on this expanding market, but success hinges on demonstrating clinical utility and securing payer coverage.
What we're watching
- Clinical Adoption
- The results of the City of Hope trial will be crucial in determining the broader adoption of Haystack MRD within oncology workflows, particularly given the test's LDT status and reliance on clinical validation.
- Regulatory Pathway
- The FDA's continued evaluation of liquid biopsy tests, following the Breakthrough Device Designation, will influence the commercialization timeline and reimbursement landscape for Haystack MRD and similar assays.
- Competitive Landscape
- The success of Haystack MRD’s validation will be weighed against competing ctDNA assays, as the market for MRD testing intensifies and diagnostic providers vie for market share.
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