India, Aug. 25 -- Quest Diagnostics (DGX), a provider of diagnostic information services, announced Monday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Haystack MRD test.
The test helps identify 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 growing evidence of the value of the Haystack MRD test for both clinical and pharmaceutical applications. It also aligns with a robust body of research supporting the potential of ctDNA-based MRD tests to detect residual or recurrent cancer from solid tumors.
Quest introd...