The approval allows Quest Diagnostics to offer its minimal residual disease test for patients in all 50 states.
Quest Diagnostics announced that the New York State Department of Health Clinical Laboratory Evaluation Program has approved the Haystack MRD test. This circulating tumor DNA (ctDNA) liquid biopsy test is used to identify residual or recurring disease in patients with a range of solid tumor cancers.
New York requires formal technical review and approval of laboratory developed tests before they may be offered to patients in the state. With this approval, Haystack MRD is now authorized for patient testing in all 50 US states. The test was developed under Clinical Laboratory Improvement Amendments regulations and has been available for clinician ordering since late 2024 in 49 states and the District of Columbia.
“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,” says Dan Edelstein, vice president and general manager for Haystack Oncology, a Quest Diagnostics company, in a release. “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.”
The test’s clinical utility was demonstrated in a study of non-operative management of patients with locally advanced mismatch repair–deficient (dMMR) solid tumors, led by Andrea Cercek, MD, medical oncologist, at Memorial Sloan Kettering Cancer Center. The study, published in The New England Journal of Medicine in May 2025, found that ctDNA testing identified clinical complete response at a median of 1.4 months, compared to more than six months using imaging methods.
“In our study of non-operative management for dMMR solid tumors, the use of MRD testing provided additional molecular information that complemented traditional assessments such as imaging and endoscopy,” says Cercek in a release. “For patients who may avoid surgery, having multiple tools to evaluate treatment response and monitor for recurrence is important. These findings highlight the crucial role of MRD testing in informing patient management and underscore the need for continued study as these approaches are integrated into clinical practice.”
Haystack MRD is a tumor-informed, next-generation minimal residual disease test that detects low levels of ctDNA to uncover residual or recurrent disease. The Food and Drug Administration granted the test Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer.
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