#United States #Quest Diagnostics #Secaucus #Haystack MRD #ctDNA Testing

Quest Diagnostics Expands Patient Access to Haystack MRD® Test

Quest Diagnostics, a leading provider in diagnostic services, has recently secured approval from the New York State Department of Health for its innovative Haystack MRD® test. This breakthrough allows for a broader deployment of circulating tumor DNA (ctDNA) testing within the state, significantly enhancing patient diagnostics related to solid tumor cancers.

Enhanced Testing Capabilities

The Haystack MRD® test is engineered to detect minimal residual disease (MRD) and monitor disease recurrence in cancer patients through a simple liquid biopsy. The New York State approval highlights the test's adherence to stringent clinical laboratory oversight standards, ensuring that it meets high technical and accuracy requirements before being offered to patients.

This approval is a milestone for Quest Diagnostics, as it means that the Haystack MRD test can now be used for patient testing in all 50 states, following its availability in 49 states and the District of Columbia since 2024. The test operates under Clinical Laboratory Improvement Amendments (CLIA) regulations, reinforcing its credibility and quality.

Dan Edelstein, Vice President and General Manager for Haystack Oncology at Quest, expressed pride in this achievement, stating, "This approval represents the culmination of our many years of hard work and commitment to delivering a highly accurate test that can meaningfully improve patient care." He emphasized that the Haystack MRD test is designed to empower oncologists by enabling them to detect residual disease and catch recurrences at earlier stages, which is vital for effective treatment planning.

Clinical Research Backing

Haystack MRD's diagnostic capabilities have been validated through rigorous research. A landmark study led by Dr. Andrea Cercek at the Memorial Sloan Kettering Cancer Center demonstrated that ctDNA testing utilizing Haystack MRD could reliably identify clinical responses much sooner than traditional imaging methods. In particular, patients with locally advanced mismatch repair-deficient (dMMR) solid tumors showed a median clinical complete response identification at just 1.4 months using the Haystack MRD test, compared to more than six months with imaging.

Dr. Cercek advised that, "For patients who may avoid surgery, having multiple tools to evaluate treatment response and monitor for recurrence is important. These findings highlight the crucial role of MRD testing in informing patient management." This reinforces the growing recognition of ctDNA testing as a vital tool in modern oncology.

Origins of Haystack MRD

Haystack Oncology, a subsidiary of Quest Diagnostics, emerged from over two decades of collaborative innovation among cancer genomics experts at Johns Hopkins School of Medicine. The result is a tumor-informed, next-generation testing method that detects very low levels of ctDNA, uncovering residual or recurring disease with remarkable sensitivity and specificity. By partnering with biopharmaceutical firms, Haystack Oncology aims to accelerate research in clinical development and advance promising therapies to the market.

The FDA has previously awarded the Haystack MRD test Breakthrough Device Designation for its application in Stage II colorectal cancer, signaling its potential impact on patient outcomes. With its validation and commercial availability, Haystack MRD is also being used in clinical trial settings across various laboratories worldwide.

The Path Forward for Quest Diagnostics

As one of the largest diagnostic testing companies in the United States, Quest Diagnostics is poised to continue leading innovations in diagnostic testing. Through its focus on more effective, streamlined testing solutions, Quest is committed to improving patient care. With the inclusion of the Haystack MRD test in its diagnostics arsenal, the company reinforces its dedication to advancing healthcare outcomes for cancer patients nationwide.

For further information on Haystack MRD and its commercial availability, please visit Haystack MRD's official site.

Quest Diagnostics continues to pave the way for advancements in patient diagnostics and treatment monitoring, ensuring a healthier future for individuals across the country.