FDA Grants Breakthrough Device Designation to Quest Diagnostics’ Haystack MRD Test

Quest Diagnostics has announced that its Haystack MRD test has been awarded Breakthrough Device Designation by the U.S. Food and Drug Administration. The test is designed to identify minimal residual disease (MRD) in patients with stage II colorectal cancer after surgery, helping oncologists determine which patients may benefit from adjuvant therapy.

The designation highlights the growing importance of circulating tumor DNA (ctDNA)-based testing in monitoring solid tumors. By detecting tumor-derived DNA fragments in the bloodstream, Haystack MRD can identify recurrence or residual disease at an earlier stage than traditional imaging, potentially guiding more precise treatment strategies. Research has shown that such liquid biopsy approaches can reveal cancer recurrence months before it becomes clinically apparent.

Quest introduced a laboratory-developed version of Haystack MRD in late 2024 and is expanding its availability to clinicians and pharmaceutical partners. The test has already been adopted across leading cancer centers and integrated into clinical trials in the U.S., Canada, and Australia.

Dan Edelstein, Vice President and General Manager of Haystack Oncology, said the recognition represents a key milestone. “We are committed to working with the FDA and research partners to validate the use of Haystack MRD across a range of solid tumors. This designation is an important step in making personalized, accurate monitoring available to more patients,” he stated.

The FDA’s Breakthrough Devices Program is intended to accelerate access to innovations that offer more effective diagnosis or treatment for life-threatening or severely debilitating conditions. By advancing development and review, the program seeks to bring clinically meaningful technologies such as Haystack MRD to patients more quickly.