Quest Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device Designation to its Haystack MRD® test. The designation is specifically for identifying minimal residual disease (MRD)-positive patients with stage II colorectal cancer following surgery, who may benefit from additional adjuvant therapy.
This designation is a significant milestone that helps accelerate the development and review of a new medical device. It is reserved for technologies that provide a more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. The designation helps to streamline the FDA’s assessment and review processes to provide patients and health care providers with timely access to new medical devices.
The Haystack MRD test, which Quest introduced as a clinical laboratory-developed test in late 2024, uses circulating tumor DNA (ctDNA) to detect tiny fragments of cancerous DNA that may remain in the bloodstream after a solid tumor has been removed. This ability to detect residual cancer can help oncologists tailor treatment plans and identify potential recurrence months before it would be visible through traditional imaging.
Dan Edelstein, vice president and general manager of Haystack Oncology, stated that the designation is a key step toward the company’s goal of delivering highly accurate, personalized monitoring to more patients. “We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumors, building on this first designation for an early-stage colorectal cancer,” he said. The designation further supports the growing body of research on the value of ctDNA-based MRD tests for both clinical care and pharmaceutical research.
