Quest Diagnostics Incorporated (NYSE:DGX) shares rose 2.2% on Wednesday after the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) granted approval for the company’s Haystack MRD test to be used to identify residual or recurring disease in patients with solid tumor cancers.
The CLEP nod permits Quest to offer the circulating tumor DNA (ctDNA) liquid biopsy to patients in New York, completing the regulatory patchwork needed for the test to be available nationwide. Quest said the assay had already been available for clinician ordering since late 2024 in 49 states and the District of Columbia; New York was the remaining jurisdiction requiring separate approval.
New York enforces a stringent oversight regime for clinical laboratories that requires formal technical review and explicit authorization of laboratory-developed tests before they can be offered to patients in the state. Quest noted that Haystack MRD was developed under Clinical Laboratory Improvement Amendments (CLIA) regulations.
According to company statements, Haystack MRD is designed to detect residual disease at an earlier stage, identify recurrence before it is clinically apparent, and help characterize patient response to treatment. Those intended purposes form the basis for the company’s positioning of the test within oncology diagnostics and patient management workflows.
The test’s clinical utility was documented in a study of non-operative management of patients with locally advanced mismatch repair-deficient solid tumors. That research, 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. In the study, ctDNA testing with Haystack MRD identified clinical complete response at a median of 1.4 months, compared with more than 6 months using imaging methods.
Dan Edelstein, Vice President and General Manager for Haystack Oncology at Quest Diagnostics, said the New York approval represents the culmination of years of work to deliver an accurate test that can improve patient care. The company framed the clearance as the final state-level approval required to make the test accessible across all 50 states.
Summary of the development:
- New York CLEP approval permits Haystack MRD to be offered to patients in New York and completes the state-level approvals needed for nationwide availability.
- The ctDNA liquid biopsy has been available for clinician ordering since late 2024 in 49 states and the District of Columbia.
- Clinical utility was shown in a study of non-operative management of locally advanced mismatch repair-deficient solid tumors, with ctDNA identifying clinical complete response faster than imaging.
This report focuses on the regulatory milestone and the study results as described by the company and the published research. It does not introduce additional claims or projections beyond those provided in company disclosures and the referenced clinical study.