Mass General Brigham Launches Two Clinical Trials to Study Haystack MRD ctDNA as Guide for Post-surgical Treatment for Two Cancer Types

SECAUCUS, N.J. and BOSTON, Aug. 7, 2025 /PRNewswire/ -- Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, today announced a research collaboration with Mass General Brigham investigators at Massachusetts Eye and Ear and Massachusetts General Hospital, world-renowned centers for head and neck and advanced cutaneous oncology. The research collaboration will investigate the use of Haystack MRD™, a highly sensitive circulating tumor DNA (ctDNA) minimal residual disease test, as an aid in postoperative therapy decisions for two cancer types: cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, and HPV-independent head and neck squamous cell carcinoma (HNSCC).

"Cancer liquid biopsy has the potential to revolutionize cancer diagnosis, treatment monitoring, and the detection of minimal residual disease (MRD) soon after therapy—helping to better personalize patient care," said Dan Faden, MD, FACS, head and neck surgical oncologist and scientist at Mass Eye and Ear, and a leading expert in head and neck cancer liquid-biopsy research. "Given its promise, studying liquid biopsy in clinical contexts such as MRD is a major focus of our laboratories and clinical services."

Dr. Faden will lead the HNSCC trial and Sophia Shalhout, PhD and Kevin Emerick, MD of the Mass Eye and Ear- Mass General Hospital Cutaneous Oncology Program will co-lead the CSCC trial. Each are investigators at the Mike Toth Head and Neck Cancer Research Center at Mass Eye and Ear.

The two prospective clinical trials aim to investigate Haystack MRD as a minimally invasive tool to help guide clinical decisions and its impact on risk stratification and enabling early detection of residual disease in cancer types that currently lack robust options for monitoring and risk assessment. Both studies will use Haystack MRD to analyze samples from patients at multiple times during and after treatment to evaluate the clinical usefulness of Haystack MRD in the clinic.

"In aggressive and often unpredictable cancers like HNSCC and CSCC, the ability to sensitively detect minimal residual disease can transform how we evaluate treatment response and monitor for recurrence. Studying these diseases with Haystack MRD offers a critical opportunity to close the gap between clinical remission and molecular relapse—bringing us closer to truly personalized, proactive cancer care," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "Our goal is to bring highly sensitive, personalized monitoring to all types of solid tumors."

Why ctDNA MRD matters

A growing body of research underscores the potential role of ctDNA MRD tests to identify residual or recurring cancer in solid tumors. In April 2025, a study published in The New England Journal of Medicine (NEJM) found that ctDNA testing, using Haystack MRD was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months compared to over six months using imaging tests. Nearly all oncologists (96%) in a recent survey by The Harris Poll for Quest Diagnostics found that MRD testing has the potential to identify cancer recurrence earlier than traditional methods.

About Haystack Oncology

Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD™, a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA to uncover residual or recurrent disease with exceptional sensitivity. Haystack Oncology works with biopharmaceutical companies to accelerate and inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics.

Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for commercial use as a lab-developed test (LDT) by 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. www.haystackmrd.com

About Quest Diagnostics

Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of deidentified clinical lab results, diagnostic insights provided by Quest reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and over 55,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

SOURCE Quest Diagnostics