Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Haystack MRD® test. The test is designed to identify MRD-positive patients with stage II colorectal cancer following curative-intent surgery, helping determine which patients may benefit from adjuvant therapy in line with therapeutic product labeling.
This designation highlights the growing clinical and pharmaceutical value of Haystack MRD and supports the expanding role of circulating tumor DNA (ctDNA)-based MRD tests in detecting residual or recurrent cancer across solid tumors. Quest first launched a laboratory-developed version of Haystack MRD in late 2024, with plans to broaden access for oncologists and pharmaceutical partners.
“We are working closely with the FDA and our research collaborators to validate Haystack MRD in multiple solid tumors,” said Dan Edelstein, Vice President and General Manager, Haystack Oncology. “This milestone brings us closer to delivering precise, personalized monitoring of treatment response and recurrence for more patients in both clinical care and pharmaceutical trials.”
The FDA Breakthrough Devices Program is designed to accelerate the development, review, and patient access to medical devices that provide more effective treatment or diagnosis of serious or life-threatening conditions, while ensuring rigorous safety and effectiveness standards.
Research continues to demonstrate the value of ctDNA MRD testing for early detection of residual or recurring cancer in solid tumors. By identifying tumor-derived DNA fragments in the blood, ctDNA MRD tests can reveal molecular signs of recurrence months before conventional imaging or monitoring. This early detection allows oncologists to adjust surveillance, tailor treatment strategies, and intervene before clinical progression. In fact, nearly 96% of oncologists in a Harris Poll survey conducted for Quest Diagnostics agreed that MRD testing can identify recurrence earlier than existing methods.
Haystack MRD is a sensitive and specific liquid biopsy test developed by leaders in cancer genomics and liquid biopsy research. It detects low levels of circulating tumor DNA (ctDNA) in the bloodstream, signaling residual, recurrent, or resistant disease in cancer patients. Currently used in multiple clinical trials and studies across the U.S., Canada, and Australia, and adopted by more than 75 leading cancer centers and health systems, Haystack MRD is now part of Quest Diagnostics’ oncology testing portfolio. The test is also available for use in pharmaceutical trials as an investigational device through Haystack Oncology laboratories in Baltimore (U.S.), Hamburg (Germany), and Helsinki (Finland).