Quest Diagnostics Receives NY Approval for Haystack MRD Test
Quest Diagnostics announced that the New York State Department of Health's, or NYSDOH, Clinical Laboratory Evaluation Program, or CLEP, has approved the company's Haystack MRD test, a circulating tumor DNA, or ctDNA, liquid biopsy test, for use in identifying residual or recurring disease in patients with a range of solid tumor cancers. New York maintains a highly rigorous clinical laboratory oversight program, requiring 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 U.S. states. The test was developed under CLIA regulations and has been available for clinician ordering since late 2024 in 49 states and the District of Columbia. In addition, Haystack MRD's clinical utility has been demonstrated in rigorous investigational settings, including the landmark study of non-operative management of patients with locally advanced mismatch repair-deficient, or dMMR, solid tumors.
