FDA Grants Breakthrough Device Designation to Quest Diagnostics' Haystack MRD Circulating Tumor DNA Test for Stage II Colorectal Cancer

Reuters
08/25
FDA Grants Breakthrough Device Designation to Quest Diagnostics' Haystack MRD Circulating Tumor DNA Test for Stage II Colorectal Cancer

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quest Diagnostics Incorporated published the original content used to generate this news brief via PR Newswire (Ref. ID: NY56860) on August 25, 2025, and is solely responsible for the information contained therein.

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