Workflow
ctDNA MRD testing
icon
Search documents
FDA Grants Breakthrough Device Designation for Haystack MRD Circulating Tumor DNA Test from Quest Diagnostics
Prnewswire· 2025-08-25 12:52
SECAUCUS, N.J., Aug. 25, 2025 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Haystack MRD® test for identifying MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling.The new designation adds to growi ...