Quest Diagnostics, a provider of diagnostic information services, today announced that the FDA has granted Breakthrough Device Designation for the company's Haystack MRD test for identifying 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.
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 healthcare 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.
