Quest Diagnostics (NYSE: DGX), a prominent leader in diagnostic information services, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Haystack MRD® test. This innovative test is designed to identify MRD-positive patients with stage II colorectal cancer following curative-intent surgery, helping determine which individuals may benefit from adjuvant therapy in alignment with approved therapeutic product labeling.
This designation underscores the growing clinical and pharmaceutical relevance of the Haystack MRD test and reflects a broader trend recognizing the potential of circulating tumor DNA (ctDNA)-based MRD tests to detect residual disease or cancer recurrence in patients with solid tumors. Quest introduced a clinical laboratory-developed version of Haystack MRD in late 2024 and continues to expand access to this technology for oncologists and pharmaceutical collaborators.
“We are proud to collaborate with the FDA and our research partners to further validate Haystack MRD for a range of solid tumors, building on this significant milestone for early-stage colorectal cancer,” stated Dan Edelstein, Vice President and General Manager of Haystack Oncology. “Our mission is to bring precise, personalized tools for monitoring treatment response and detecting recurrence to as many patients as possible, both within routine clinical care and across pharmaceutical development. Achieving Breakthrough Device Designation represents a critical step toward that objective.”
The FDA’s Breakthrough Devices Program is designed to accelerate the development, review, and potential approval of medical devices and device-led combination products that offer transformative treatment or diagnostic solutions for life-threatening or irreversibly debilitating conditions. By granting this designation, the FDA recognizes the promise of the Haystack MRD test to enhance cancer management and provide timely access to a cutting-edge diagnostic tool that meets the agency’s stringent standards for safety and effectiveness.
With this advancement, Quest Diagnostics strengthens its position at the forefront of precision oncology, advancing innovation aimed at improving outcomes for patients facing some of the most challenging cancers.
