Quest Diagnostics IncorporatedNew York State approval expands test availability to all 50 states, a regulatory milestone.

Quest Diagnostics has received New York State Department of Health approval for its Haystack MRD circulating tumor DNA liquid biopsy test, broadening patient access to minimal residual disease testing for solid tumor cancers. The approval from the Clinical Laboratory Evaluation Program means the test is now authorized for patient testing in all 50 U.S. states, having been available in 49 states and the District of Columbia since late 2024. Haystack MRD is a tumor-informed next-generation test designed to detect ultralow levels of ctDNA, and its clinical utility was demonstrated in a landmark study published in The New England Journal of Medicine in May 2025, where it identified clinical complete response at a median of 1.4 months versus more than 6 months with imaging. The test was developed under CLIA regulations and received FDA Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer.
Quest Diagnostics IncorporatedNew York State approval expands test availability to all 50 states, a regulatory milestone.