Quest Diagnostics announced that the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) has approved its Haystack MRD test for use in identifying residual or recurring disease in patients with solid tumor cancers. This approval authorizes the test for patient testing in all 50 U.S. states. The test, a circulating tumor DNA (ctDNA) liquid biopsy, was developed under CLIA regulations and has been available for clinician ordering since late 2024 in 49 states and the District of Columbia.

New York requires formal technical review and approval of laboratory developed tests before they may be offered to patients. With this approval, Haystack MRD meets the state's rigorous clinical laboratory oversight standards. Dan Edelstein, Vice President and General Manager for Haystack Oncology, a Quest Diagnostics company, stated that the approval represents the culmination of years of work to deliver a highly accurate test that can improve patient care.

Haystack MRD's clinical utility was demonstrated in a landmark study of non-operative management of patients with locally advanced mismatch repair–deficient solid tumors. The study, led by Dr. Andrea Cercek and colleagues at Memorial Sloan Kettering Cancer Center, was published in The New England Journal of Medicine in May 2025. The study found that ctDNA testing using Haystack MRD was a reliable liquid biopsy surrogate that identified clinical complete response at a median of 1.4 months, compared to more than 6 months using imaging methods.

Key Details of Haystack MRD Approval

Haystack Oncology, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD. The test is a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA. The FDA granted Haystack MRD Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer. Haystack Oncology also offers the test for clinical trials as an investigational device in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland.