City of Hope Launches Multi-Cancer Study of Quest Diagnostics' Haystack MRD Test Across 14 Sites
核心洞察
City of Hope (搜索) is implementing Quest Diagnostics' Haystack MRD (搜索) circulating tumor DNA test in a multi-year research program across 14 sites to guide patient management in breast, colorectal, ovarian, and prostate cancers.
The clinical trials will evaluate approximately 500 patients with thousands of longitudinal measurements to assess the test's ability to detect minimal residual disease, monitor treatment response, and identify recurrence earlier than standard imaging.
The research spans multiple patient management settings including neoadjuvant, adjuvant, and post-treatment surveillance, with the potential to help determine surgical success and spare unnecessary chemotherapy treatments.
Quest Diagnostics announced that City of Hope (搜索), one of the largest cancer research and treatment organizations in the United States, is implementing Haystack MRD (搜索)®, a highly accurate circulating-tumor DNA (搜索) (ctDNA (搜索)) minimal residual disease test, for clinical trial participants with solid tumor cancers (搜索). The multi-year research program will evaluate the test's effectiveness in guiding disease management for patients with breast, colorectal, ovarian, and prostate cancer (搜索) across fourteen City of Hope sites nationwide.
Comprehensive Multi-Site Research Program
The research collaboration is expected to serve approximately 500 patients with thousands of longitudinal measurements from City of Hope (搜索) locations in Los Angeles, Orange County, Chicago, Phoenix, and Atlanta areas. The clinical trials are investigating Haystack MRD (搜索) across multiple patient management settings, including neoadjuvant, adjuvant, and post-treatment surveillance phases.
"City of Hope (搜索) brings together the scientific expertise, clinical infrastructure, and advanced technology needed to evaluate emerging approaches that can meaningfully improve cancer care and health outcomes for patients," said Cristian Tomasetti, Ph.D, Professor and Director, Center for Cancer Prevention, Early Detection and Monitoring, City of Hope. "We see liquid biopsy as an important frontier in oncology and aim to leverage the most accurate and effective commercially available ctDNA (搜索) assays while also working to develop effective early detection platforms."
Clinical Applications and Patient Impact
The research is evaluating whether the test can detect minimal residual disease, monitor treatment response, and identify recurrence earlier than standard imaging modalities. According to Dr. Tomasetti, who is also a Professor in the Early Detection and Prevention Division at the Translational Genomics Research Institute (TGen), part of City of Hope (搜索), the technology could have significant clinical implications.
"New blood test technologies can make a significant difference for a patient. For example, they may help determine that a surgery was able to fully remove the cancer, thereby sparing chemotherapy treatment," Dr. Tomasetti explained.
Technology and Regulatory Status
Haystack MRD (搜索) is a tumor-informed, next-generation MRD test that detects ultralow levels of ctDNA (搜索) to uncover residual or recurrent disease with exceptional sensitivity and specificity. The test represents over 20 years of collaboration in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine (搜索) through Haystack Oncology (搜索), a wholly owned subsidiary of Quest Diagnostics.
The FDA granted Haystack MRD (搜索) Breakthrough Device Designation in 2025 for use in Stage II colorectal cancer (搜索). The test is currently available for commercial use as a lab-developed test (LDT) by Quest Diagnostics and for clinical trials as an investigational device in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland.
Clinical Evidence and Market Perspective
A growing body of research supports the value of ctDNA (搜索)-based MRD testing for identifying residual or recurring cancer in solid tumors. By detecting trace amounts of tumor-derived DNA in the bloodstream, ctDNA MRD testing can reveal molecular evidence of disease recurrence months before it becomes apparent through imaging or other conventional monitoring methods.
Nearly all oncologists (96%) in a survey by Harris Poll for Quest Diagnostics indicated that MRD testing has the potential to identify cancer recurrence earlier than other current methods. This early insight can help clinicians tailor surveillance strategies, adjust treatment plans, and potentially intervene before disease progression becomes clinically evident.
"Haystack MRD (搜索) is designed to help clinicians and their patients act earlier with greater confidence, based on the principle that cancer survivors and their care teams should be able to make proactive, not reactive, healthcare decisions," said Dan Edelstein, Vice President and General Manager of Haystack Oncology (搜索). "We believe the research collaboration will generate important evidence supporting the role of Haystack MRD in informing patient management across multiple solid tumor settings."
