Quest Diagnostics Incorporated has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Haystack MRD® test. This test is designed to identify MRD-positive patients with stage II colorectal cancer following curative-intent surgical treatment, potentially benefiting from adjuvant therapy. The designation is part of the FDA's Breakthrough Devices Program, which aims to expedite the development and review process for devices that offer more effective treatment or diagnosis of serious conditions. This development highlights the growing evidence supporting the test's value for both clinical and pharmaceutical applications and underscores Quest's commitment to advancing personalized cancer treatment and monitoring.