Quest Diagnostics has received approval from the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Programme for its Haystack minimal residual disease (MRD) test, expanding its use to cancer patients throughout the US.
The clearance enables clinicians in New York to access the Haystack MRD assay, a circulating tumour deoxyribonucleic acid (ctDNA) liquid biopsy test designed to detect minimal residual or recurring disease in a range of solid tumour cancers.
New York state requires formal review and authorisation for laboratory-developed tests before they are offered to patients, a process considered one of the most stringent in the country.
Quest Diagnostics had previously launched Haystack MRD for clinical ordering in late 2024, available to healthcare providers in 49 states and the District of Columbia under Clinical Laboratory Improvement Amendments regulations.
Haystack Oncology vice-president and general manager Dan Edelstein said: “This approval represents the culmination of our many years of hard work and commitment to delivering a highly accurate test that can meaningfully improve patient care.
“Haystack MRD was designed to give oncologists the confidence to detect residual disease earlier, catch recurrence before it becomes clinically apparent and help identify response to treatment.
“New York's approval is another proof point for Haystack MRD's quality and technical sophistication, and we look forward to extending access to this important innovation for clinicians and patients in the state.”
Haystack Oncology, a Quest Diagnostics company, focuses on advancing liquid biopsy technologies.
According to Quest Diagnostics, the clinical utility of Haystack MRD has been evaluated in investigational settings, including a study led by Dr Andrea Cercek at the Memorial Sloan Kettering Cancer Center.
Published in the New England Journal of Medicine in May 2025, the research found that ctDNA testing using Haystack MRD identified clinical complete response at a median of 1.4 months, contrasting with more than six months for traditional imaging.
Haystack MRD is also available as an investigational device in clinical studies and holds breakthrough device designation from the Food and Drug Administration for Stage II colorectal cancer.
Earlier this year, Quest Diagnostics introduced a new flow cytometry MRD blood test for myeloma, a cancer arising from abnormal plasma cells.
