On August 25, 2025 Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Haystack MRD test for identifying 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 (Press release, Quest Diagnostics, AUG 25, 2025, View Source [SID1234655464]).
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The new designation adds to growing evidence of the value of the Haystack MRD test for both clinical and pharmaceutical applications. It also aligns with a robust body of 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," said Dan Edelstein, Vice President and General Manager, Haystack Oncology. "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.
About ctDNA MRD
A growing body of research underscores the value of ctDNA MRD tests 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 survey1 by Harris Poll for Quest Diagnostics said MRD testing has the potential to identify cancer recurrence earlier than other current methods.
About Haystack MRD
Haystack MRD is a highly sensitive and 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 patients diagnosed with cancer. Used in multiple clinical trials and research studies with top institutions in the U.S., Canada, and Australia, and by clinicians at over 75 top cancer and academic centers and health systems, Haystack MRD is now available for clinical use as part of the leading 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, Maryland; Hamburg, Germany; and Helsinki, Finland. For more information, visit www.haystackmrd.com.