Haystack Oncology, a Quest Diagnostics company, has announced a research collaboration with Mass General Brigham investigators to launch two clinical trials evaluating the Haystack MRD™ circulating tumor DNA test for postoperative treatment guidance in two challenging cancer types. The trials will focus on cutaneous squamous cell carcinoma (CSCC) and HPV-independent head and neck squamous cell carcinoma (HNSCC), both aggressive malignancies that currently lack robust monitoring options.
Clinical Trial Leadership and Design
Dr. Dan Faden, a head and neck surgical oncologist and scientist at Mass Eye and Ear, will lead the HNSCC trial. The CSCC trial will be co-led by Dr. Sophia Shalhout and Dr. Kevin Emerick from the Mass Eye and Ear-Mass General Hospital Cutaneous Oncology Program. All investigators are affiliated with the Mike Toth Head and Neck Cancer Research Center at Mass Eye and Ear.
The two prospective clinical trials are designed to investigate Haystack MRD as a minimally invasive tool for clinical decision-making, with particular focus on risk stratification and early detection of residual disease. Both studies will analyze patient samples at multiple time points during and after treatment to evaluate the clinical utility of the ctDNA test.
Addressing Critical Gaps in Cancer Monitoring
"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," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "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."
Dr. Faden emphasized the transformative potential of liquid biopsy technology, stating, "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."
Supporting Evidence for ctDNA MRD Testing
The clinical trials build on compelling evidence for ctDNA-based minimal residual disease testing. A study published in The New England Journal of Medicine in April 2025 demonstrated that ctDNA testing using Haystack MRD served as a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months, compared to over six months required by traditional imaging tests.
The clinical community has shown strong support for MRD testing, with nearly all oncologists (96%) in a recent survey by The Harris Poll for Quest Diagnostics indicating that MRD testing has the potential to identify cancer recurrence earlier than traditional methods.
Technology and Development Background
Haystack MRD represents over 20 years of collaborative development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The tumor-informed, next-generation MRD test detects ultralow levels of ctDNA to uncover residual or recurrent disease with exceptional sensitivity.
The test has been developed and validated in a CLIA-certified laboratory and is available for commercial use as a lab-developed test through Quest Diagnostics. For clinical trials, Haystack MRD is available as an investigational device through Haystack Oncology laboratories in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland.
Clinical Impact and Future Directions
The collaboration represents a significant advancement in personalized cancer monitoring, particularly for cancer types that have historically lacked effective surveillance tools. Edelstein noted that Haystack Oncology's goal is "to bring highly sensitive, personalized monitoring to all types of solid tumors."
The trials will provide crucial data on the clinical utility of ctDNA-based MRD testing in guiding treatment decisions and improving patient outcomes in two challenging cancer types. The research collaboration leverages the expertise of Mass General Brigham's world-renowned centers for head and neck and advanced cutaneous oncology to advance the field of precision oncology.
