Haystack MRD® Demonstrates Robust Clinical Performance in Specimen Cohort from the Landmark DYNAMIC Colorectal Cancer Trials

Recurrence-detection sensitivity was 88.9% versus 11.1% for the standard blood marker CEA at median follow-up of 60 months.

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Quest Diagnostics (DGX) reported study results showing its Haystack MRD blood test predicted colorectal cancer recurrence with 100% specificity in the evaluated cohort. Published in The Journal of Molecular Diagnostics, the study retrospectively tested residual specimens from patients in the DYNAMIC and DYNAMIC-III trials of stage II and III colorectal cancer. The test detects circulating tumor DNA, fragments of tumor genetic material in blood, to identify residual or recurrent disease.

Sensitivity was 100% at three years and 83.3% at five years, with 100% specificity at both follow-ups, meaning no false-positive results in the cohort. In a separate comparison at median follow-up of 60 months, recurrence-detection sensitivity was 88.9%, versus 11.1% for the standard blood marker CEA. Analytical performance was validated across 23 solid tumor types; an Early Experience clinical cohort showed tumor DNA detection across 27 types.

Positive

• Minor pointThree-year recurrence prediction achieved 100% sensitivity and 100% specificity in the evaluated specimen cohort.
• Minor pointFive-year recurrence prediction achieved 83.3% sensitivity and 100% specificity in the evaluated specimen cohort.
• Minor pointRecurrence-detection sensitivity was 88.9% versus 11.1% for CEA at median follow-up of 60 months.
• Minor pointAnalytical validation covered 23 solid tumor types and the complete testing process, including DNA extraction.
• Minor point95% detection limit was 0.063 mean circulating tumor DNA molecules per milliliter of plasma.

5 minor points

• Minor pointQuantitation limit of 0.25 mean circulating tumor DNA molecules per milliliter supports response monitoring.
• Minor pointInvestigational whole-genome testing achieved 0.8 parts per million detection, as low as 0.2 in some samples.
• Minor pointCancer-free controls produced no false positives with the investigational whole-genome version.
• Minor pointEarly Experience cohort showed tumor DNA detection across 27 solid tumor types.
• Minor point42% of positive Early Experience results were below 0.5 mean circulating tumor DNA molecules per milliliter.

Negative

• Minor pointClinical recurrence results came from retrospective testing of residual DYNAMIC and DYNAMIC-III specimens.
• Minor pointWhole-genome version is investigational and currently available only to clinical investigators and biopharma partners.

News Explained

The reported detection down to 0.2 PPM applies to an investigational whole-genome version available only to clinical investigators and biopharma partners; the commercial test uses whole-exome sequencing.

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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

SECAUCUS, N.J., Oct. 1, 2026 /PRNewswire/ -- A new study published in The Journal of Molecular Diagnostics showed that the Haystack MRD® test is highly accurate at detecting residual and recurrent disease, demonstrating clinical performance in specimens from the landmark DYNAMIC colorectal cancer trial series. The study also validated the test’s analytical performance across 23 solid tumor types. Provided by Quest Diagnostics (NYSE: DGX), Haystack MRD is an ultrasensitive circulating tumor DNA (ctDNA) liquid biopsy test for identifying residual or recurrent disease in patients with solid tumor cancers. 

The study evaluated the clinical performance of the commercially available Haystack MRD test by retrospectively testing residual specimens from patients enrolled in the DYNAMIC and DYNAMIC-III trials, which evaluated the use of ctDNA-based MRD results (generated with an earlier version of the Haystack MRD technology) to guide chemotherapy decisions in stage II and III colorectal cancer. In this cohort, Haystack MRD results were highly associated with recurrence, demonstrating 100% sensitivity and 100% specificity at 3-year follow-up and 83.3% sensitivity and 100% specificity at 5-year follow-up. Haystack MRD also substantially outperformed carcinoembryonic antigen (CEA), a standard blood-based biomarker, detecting recurrence with 88.9% sensitivity versus 11.1% for CEA (median follow-up 60 months).

Scientists from Quest and Haystack Oncology conducted the study together with investigators from the two institutions that led the DYNAMIC trials: The Walter and Eliza Hall Institute of Medical Research and the Peter MacCallum Cancer Center 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," said Professor Jeanne Tie,* a medical oncologist at Peter MacCallum Cancer Centre and lead investigator for the DYNAMIC trial series. "This study helps bridge the gap between clinical research and real-world patient care."

In other key findings, Haystack MRD:

• Demonstrated ultrasensitive detection of residual disease, with a 95% limit of detection (LoD95) of 0.063 mean ctDNA molecules per milliliter (mL) of plasma. Earlier validation established an LoD95 of 6 parts per million (PPM), a metric commonly reported for tumor-informed MRD assays¹.
• Achieved sub-PPM detection of 0.8 PPM, and as low as 0.2 PPM in some samples, with no false positives in cancer-free controls using an investigational whole-genome version of the test. This whole-genome version is currently only available to clinical investigators and biopharma partners while the commercial test uses whole-exome sequencing.
• Established a limit of quantitation (LOQ) suitable for response monitoring of 0.25 mean ctDNA molecules per mL. Establishing the LOQ allows a change in a patient's ctDNA level between serial tests to be interpreted as a real change in tumor burden rather than assay variability.
• Demonstrated analytical performance across the complete testing process, starting from plasma collection and including cell free (cf) DNA extraction, rather than starting with already extracted cfDNA. As a result, analytical performance can be directly translated to clinical performance, versus assay validations that begin with extracted cfDNA and do not account for extraction variability.  

"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," said study co-author 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. 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, the study examined a real-world clinical cohort from an Early Experience program in which Haystack MRD detected ctDNA across 27 solid tumor types, including at ultra-low concentrations, with 42% of positive results below 0.5 mean ctDNA molecules/mL.

The new study adds to the growing body of evidence supporting the clinical value of Haystack MRD, following two studies published in The New England Journal of Medicine. Published in 2022, DYNAMIC was the first prospective, interventional study to demonstrate the clinical utility of ctDNA-based MRD testing to reduce the use of chemotherapy in stage II colon cancer without compromising recurrence-free survival. In 2025, a study on response to immunotherapy in mismatch repair-deficient cancers found that the Haystack MRD test was a "reliable liquid biopsy surrogate" that identified clinical complete response at a median of 1.4 months, compared with more than 6 months using imaging.

*Dr. Tie has served as an advisor and consultant for Haystack Oncology.

About Quest Diagnostics

Quest Diagnostics works across healthcare to create a healthier world, one life at a time. We connect people, from clinicians to consumers, with laboratory insights that illuminate a path to better health. With a focus on delivering smarter, simpler testing, we help reveal new avenues to identify and treat disease, empower healthy behaviors and improve healthcare management. Quest Diagnostics serves half the physicians and hospitals in the United States and one in three American adults each year, and our nearly 60,000 employees work together to deliver diagnostic insights that inspire actions to transform lives. www.QuestDiagnostics.com

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 and specificity. 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. The FDA granted Haystack MRD Dx Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer. 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. Haystack MRD is now authorized for patient access in all 50 U.S. states. www.haystackmrd.com

1. Prathapam R, Champion K, Blakely K, et al. Analytical validation of the Haystack MRD assay for the detection of extremely low ctDNA in solid tumor patients. Poster presented at: Association for Molecular Pathology 2024 Annual Meeting and Expo; November 19, 2024; Vancouver, BC, Canada. doi:10.1016/S1525-1578(24)00232-0

 

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SOURCE Quest Diagnostics

FAQ

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How accurate was Quest Diagnostics' Haystack MRD test in the DYNAMIC specimen cohort?

Haystack MRD achieved 100% sensitivity and 100% specificity at three years, and 83.3% sensitivity and 100% specificity at five years. There were no false-positive results at either follow-up. These results came from retrospective testing of residual specimens from patients in the DYNAMIC and DYNAMIC-III colorectal cancer trials.

How did Quest Diagnostics' Haystack MRD compare with CEA for detecting colorectal cancer recurrence?

Haystack MRD detected recurrence with 88.9% sensitivity versus 11.1% for CEA at a median follow-up of 60 months. CEA, or carcinoembryonic antigen, is a standard blood-based biomarker.

Is the whole-genome Haystack MRD test available commercially?

The whole-genome version is investigational and currently available only to clinical investigators and biopharma partners. The commercially available Haystack MRD test uses whole-exome sequencing instead. The whole-genome version achieved detection at 0.8 parts per million, and as low as 0.2 parts per million in some samples.

What does the Haystack MRD quantitation limit mean for treatment monitoring?

The study established a limit of quantitation of 0.25 mean circulating tumor DNA molecules per milliliter, suitable for response monitoring. This is the level at which the test can reliably measure the amount present, allowing changes between serial tests to be interpreted as changes in tumor burden rather than assay variability.