Quest Diagnostics Secures New York Approval for Haystack MRD Test — Quest Diagnostics

Event summary

Quest Diagnostics' Haystack MRD® test received approval from New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) on June 24, 2026.
The approval allows the ctDNA liquid biopsy test to be used in all 50 U.S. states for identifying residual or recurring disease in patients with solid tumor cancers.
Haystack MRD was previously available in 49 states and the District of Columbia since late 2024 under CLIA regulations.
The test's clinical utility was demonstrated in a landmark study published in The New England Journal of Medicine in May 2025.

The big picture

Quest Diagnostics' approval of the Haystack MRD test in New York marks a significant milestone in the company's efforts to broaden access to advanced diagnostic tools. This development aligns with the growing trend towards personalized medicine and the increasing reliance on liquid biopsy technologies for early detection and monitoring of cancer. The test's ability to detect residual disease earlier than traditional imaging methods positions it as a critical tool in oncology, potentially influencing treatment protocols and patient outcomes.

What we're watching

Market Expansion: The pace at which Quest Diagnostics can leverage this approval to expand its market reach and increase adoption of the Haystack MRD test.
Clinical Integration: How effectively oncologists integrate ctDNA testing into standard clinical practice for monitoring treatment response and recurrence.
Regulatory Dynamics: Whether the FDA's Breakthrough Device Designation for Haystack MRD in Stage II colorectal cancer will accelerate broader regulatory endorsements.