Haystack MRD® Demonstrates Robust Clinical Performance in Specimen Cohort from the Landmark DYNAMIC Colorectal Cancer Trials
Key Highlights
- ➤100% specificity with no false positives at 3- and 5-year follow-up
- ➤Sensitivity reached 100% at 3 years and 83.3% at 5 years
- ➤Haystack MRD detected recurrence with 88.9% sensitivity versus CEA’s 11.1%
- ➤Haystack MRD achieved a 0.063 mean ctDNA molecules/mL LoD95
- ➤Quest Diagnostics (DGX) study validated Haystack MRD across 23 solid tumor types
Expert Statements
Jeanne Tie, Professor and medical oncologist at Peter MacCallum Cancer Centre; lead investigator for the DYNAMIC trial series
“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”
Jeanne Tie, Professor and medical oncologist at Peter MacCallum Cancer Centre; lead investigator for the DYNAMIC trial series
“This study helps bridge the gap between clinical research and real-world patient care.”
Dan Edelstein, Vice President and General Manager, Haystack Oncology
“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.”
Dan Edelstein, Vice President and General Manager, Haystack Oncology
“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.”
Dan Edelstein, Vice President and General Manager, Haystack Oncology
“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.”
Haystack MRD® Demonstrates Robust Clinical Performance in Specimen Cohort from the Landmark DYNAMIC Colorectal Cancer Trials PR Newswire
Test showed 100% specificity, with no false-positive results in the cohort, at both 3- and 5-year follow-up, and sensitivity of 100% and 83.3%, respectively, for predicting disease recurrence
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