SECAUCUS, N.J., June 24, 2026
Quest Diagnostics announced that the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) has approved the company’s Haystack MRD®, a highly sensitive circulating tumor DNA (ctDNA) liquid biopsy test designed to detect minimal residual disease (MRD) and cancer recurrence in patients with a broad range of solid tumor cancers. The approval represents a major milestone for the company, enabling the advanced molecular diagnostic test to be offered in all 50 U.S. states. New York maintains one of the most rigorous regulatory review processes for laboratory-developed tests, making the approval a significant validation of the test’s analytical performance, quality standards, and clinical reliability.
New York Approval Expands Nationwide Access
With this regulatory clearance, healthcare providers and cancer patients in New York can now access Haystack MRD, which has been available since late 2024 in 49 states and the District of Columbia. The test was developed under CLIA regulations and is designed to identify tiny traces of tumor DNA that remain in the body following treatment. Detecting these molecular signals earlier than traditional methods may allow physicians to identify recurrence sooner, evaluate treatment effectiveness, and make more informed decisions regarding patient management. According to Quest Diagnostics, the approval highlights the technical sophistication of the assay and strengthens its position in the rapidly growing field of precision oncology and liquid biopsy testing.
Clinical Evidence Demonstrates Strong Utility
The clinical value of Haystack MRD has been demonstrated in several investigational studies, including a landmark study led by researchers at Memorial Sloan Kettering Cancer Center and published in The New England Journal of Medicine in 2025. In that study involving patients with locally advanced mismatch repair-deficient (dMMR) solid tumors, the test served as a reliable molecular indicator of complete response to treatment. Researchers found that ctDNA testing using Haystack MRD identified treatment response at a median of 1.4 months, significantly earlier than imaging-based approaches, which required more than six months. These findings underscore the growing importance of liquid biopsy technologies in cancer monitoring, surveillance, and treatment optimization.
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Regenerative Medicine Continues Expanding in Rare Disease Treatment
Quest Diagnostics stated that the approval reinforces its commitment to expanding access to advanced cancer diagnostics and improving outcomes through earlier disease detection. Developed by Haystack Oncology, a wholly owned subsidiary of Quest Diagnostics, the test is based on more than two decades of research in cancer genomics and liquid biopsy technologies. Haystack MRD utilizes a tumor-informed next-generation sequencing approach capable of detecting ultra-low levels of circulating tumor DNA with exceptional sensitivity and specificity. The technology has also attracted regulatory recognition, receiving FDA Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer. As adoption of precision medicine continues to grow, Haystack MRD is expected to play an increasingly important role in helping oncologists monitor disease progression, assess treatment response, and personalize care strategies for patients with solid tumors.
Source: Quest Diagnostics press release
