Quest Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Haystack MRD test.
The test identifies 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 introduced a clinical laboratory-developed test version of Haystack MRD in late 2024 and is broadening access for oncologists and pharmaceutical partners.
“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,” said Dan Edelstein, vice president and general manager, Haystack Oncology. “Our goal is to deliver highly accurate, personalized monitoring of treatment response and recurrence to more patients, both in clinical care and in pharmaceutical trials, and this Breakthrough Designation brings us closer to our goal.”
The Breakthrough Devices Program applies to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
It is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment and review for premarket approval, 510(k) clearance and De Novo marketing authorization, after undergoing the FDA’s rigorous standards for device safety and effectiveness.
