The ctDNA liquid biopsy demonstrated 100% specificity and outperformed standard CEA testing in residual specimen analysis.
A study published in The Journal of Molecular Diagnostics shows that the Haystack MRD test accurately detects residual and recurrent colorectal cancer, demonstrating clinical performance in patient specimens from the DYNAMIC clinical trial series. The study also validated the test’s analytical performance across 23 solid tumor types.
Provided by Quest Diagnostics, Haystack MRD is an ultrasensitive circulating tumor DNA (ctDNA) liquid biopsy test designed to identify residual or recurrent disease in patients with solid tumor cancers.
The study evaluated the performance of the commercially available test by retrospectively analyzing residual specimens from patients enrolled in the DYNAMIC and DYNAMIC-III trials. Those trials investigated the use of ctDNA-based minimal residual disease (MRD) results to guide adjuvant chemotherapy decisions in stage II and stage III colorectal cancer.
Clinical and Analytical Performance
In the trial cohort, Haystack MRD results strongly correlated with disease recurrence, demonstrating 100% sensitivity and 100% specificity at 3-year follow-up, and 83.3% sensitivity and 100% specificity at 5-year follow-up, with no false-positive results. The assay also outperformed carcinoembryonic antigen (CEA), a standard blood-based biomarker, detecting recurrence with 88.9% sensitivity compared to 11.1% for CEA over a median follow-up of 60 months.
Scientists from Quest Diagnostics and Haystack Oncology conducted the research in collaboration with investigators from the Walter and Eliza Hall Institute of Medical Research and the Peter MacCallum Cancer Centre in Melbourne, Australia.
“The DYNAMIC trial demonstrated the potential for ctDNA to guide more individualized treatment decisions in stage II colon cancer but realizing that potential depends on a highly sensitive assay that can reliably detect the extremely small amounts of tumor DNA that may remain after treatment, while maintaining high specificity,” says Jeanne Tie, medical oncologist at Peter MacCallum Cancer Centre and lead investigator for the DYNAMIC trial series, in a release. “This study helps bridge the gap between clinical research and real-world patient care.”
Quantification and Real-World Cohort Data
The validation characterized the entire ctDNA testing process, beginning with plasma collection and cell-free DNA (cfDNA) extraction, for quantitative analytical performance and limit of detection at 95%.
“To our knowledge, this is the first time that the full ctDNA MRD testing process, starting from plasma collection and including cfDNA extraction, has been characterized for the limit of detection (at 95%) and quantitative analytical performance,” says Dan Edelstein, vice president and general manager at Haystack Oncology, in a release. “The precise quantitative measurements demonstrated in this validation provide confidence that the Haystack MRD test accurately measures changes in ctDNA levels over time and can be used for serial ctDNA monitoring during and after treatment. With these insights, clinicians can understand the degree of change in ctDNA levels related to tumor biology in an individual patient, supporting earlier evaluation of treatment response and detection of molecular progression or recurrence.”
In addition, researchers evaluated an Early Experience clinical cohort in which the assay detected ctDNA across 27 solid tumor types, including at ultra-low concentrations where 42% of positive results fell below 0.5 mean ctDNA molecules per milliliter.
Haystack MRD was developed in a CLIA-certified laboratory and is available as a laboratory-developed test through Quest Diagnostics across all 50 US states. The FDA granted Haystack MRD Dx Breakthrough Device Designation in 2025 for use in stage II colorectal cancer.
ID 100626058 | Colorectal Cancer © Shao-chun Wang | Dreamstime.com
