FDA grants Quest Diagnostics Breakthrough Device Designation for Haystack MRD test

Haystack MRD Test Earns FDA Breakthrough Device Designation in Stage II CRC

Developers launched a clinical laboratory-developed test version of Haystack MRD in late 2024 and are further expanding access for oncologists.

FDA Grants Breakthrough Device Status to MRD Test in Colorectal Cancer

The FDA granted breakthrough device designation to Quest Diagnostics’ Haystack MRD test for patients with stage 2 colorectal cancer after surgery.

FDA grants breakthrough device designation for Quest Diagnostics' MRD test

The US Food and Drug Administration (FDA) has granted breakthrough device designation for Quest Diagnostics’ Haystack MRD test.The post FDA grants breakthrough device designation for Quest Diagnostics’ MRD test appeared first on Medical Device Network.

FDA grants Quest Diagnostics Breakthrough Device Designation for Haystack MRD test

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 fo…