Circulating Tumor DNA Test From Quest Diagnostics Wins Breakthrough Designation

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to Quest Diagnostics’ Haystack MRD test. The assay identifies MRD-positive patients with stage II colorectal cancer after surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling.

The new designation adds to growing evidence of the Haystack MRD test’s value for both clinical and pharmaceutical applications. It also aligns with research supporting the potential of ctDNA-based MRD tests to detect residual or recurrent cancer from solid tumors. 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,” Haystack Oncology Vice President/General Manager Dan Edelstein said. “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.

A growing body of research underscores ctDNA MRD tests’ value for identifying residual or recurring cancer in solid tumors.  By detecting trace amounts of tumor-derived DNA in the bloodstream, ctDNA MRD testing can reveal molecular evidence of disease recurrence months before it becomes apparent through imaging or other conventional monitoring methods. This early insight can help clinicians tailor surveillance strategies, adjust treatment plans, and potentially intervene before disease progression becomes clinically evident. Nearly all oncologists (96%) in a recent survey by Harris Poll for Quest Diagnostics said MRD testing can potentially identify cancer recurrence earlier than other current methods. 

Haystack MRD is a highly sensitive, specific liquid biopsy test designed by cancer genomic pioneers and liquid biopsy experts to uncover low levels of circulating-tumor DNA (ctDNA)—tiny fragments of DNA in the bloodstream that originate from tumor cancer cells that can signify residual, recurrent, or resistant disease in cancer patients. Used in multiple clinical trials and research studies with top institutions in the United States, Canada, and Australia, and by clinicians at more than 75 top cancer and academic centers and health systems, Haystack MRD is now available for clinical use as part of the oncology testing portfolio of Quest Diagnostics. Haystack MRD is also available for clinical trials as an investigational device by Haystack Oncology in laboratories located in Baltimore; Hamburg, Germany; and Helsinki, Finland.

Quest Diagnostics provides diagnostic insights from the results of its laboratory testing to improve health outcomes. Derived from one of the world’s largest databases of de-identifiable clinical lab results, Quest’s diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and employs more than 55,000 workers.