Quest Resource Holding's Haystack MRD Test Receives FDA Breakthrough Designation for Cancer Detection
- Quest Diagnostics' Haystack MRD® test receives FDA Breakthrough Device Designation for detecting minimal residual disease in colorectal cancer.
- The Haystack MRD test utilizes ctDNA technology for earlier cancer recurrence detection, enhancing personalized treatment strategies.
- Quest aims to expand the Haystack MRD test's accessibility, improving patient monitoring and outcomes in oncology.
Quest Resource Holding Pioneers in Cancer Detection with FDA Breakthrough Designation for Haystack MRD Test
Quest Diagnostics (NYSE: DGX) solidifies its position as a leader in diagnostic innovation with the recent announcement of the U.S. Food and Drug Administration (FDA) granting Breakthrough Device Designation for its Haystack MRD® test. This advanced diagnostic tool is specifically designed to identify minimal residual disease (MRD) in stage II colorectal cancer patients following surgery. The significance of this designation lies in its potential to transform post-operative care by helping clinicians determine which patients may benefit from additional adjuvant therapy. As the demand for precise and timely cancer monitoring grows, the Haystack MRD test emerges as a crucial asset in the fight against colorectal cancer, focusing on patient-centered outcomes.
The Haystack MRD test leverages cutting-edge technology that detects circulating tumor DNA (ctDNA) in the bloodstream, enabling the identification of residual or recurrent cancer before it becomes clinically evident through traditional imaging methods. This advancement is particularly noteworthy, as research underscores the efficacy of ctDNA-based MRD tests, with a recent Harris Poll survey revealing that 96% of oncologists believe MRD testing can lead to earlier detection of recurrences compared to existing diagnostic techniques. As oncologists increasingly rely on this technology to inform treatment decisions, the Haystack MRD test signifies a pivotal shift toward personalized medicine, where treatment is tailored to the individual patient’s cancer status.
Dan Edelstein, Vice President and General Manager of Haystack Oncology at Quest, articulates the company's commitment to advancing cancer care through collaboration with the FDA and research partners. With the clinical laboratory-developed version of the Haystack MRD test launched in late 2024, Quest is on an expansion trajectory to make this critical diagnostic tool accessible to oncologists and pharmaceutical partners. By validating the test across various solid tumors, Quest aims not only to enhance patient monitoring but also to facilitate timely treatment adjustments, ultimately improving patient outcomes in oncology.
In addition to its groundbreaking MRD test, Quest’s dedication to advancing cancer diagnostics underscores a broader industry trend toward integrating innovative technologies in patient care. The FDA's Breakthrough Devices Program plays a crucial role in this evolution, expediting access to medical devices that can significantly enhance treatment and diagnosis of life-threatening conditions. As Quest continues to pioneer advancements in the oncology space, it reinforces the importance of early detection and personalized treatment strategies that are vital to improving survival rates among cancer patients.
As the healthcare landscape evolves, Quest Diagnostics remains at the forefront, driving change and fostering impactful collaborations aimed at revolutionizing cancer care. The Haystack MRD test not only exemplifies technological innovation but also reflects an unwavering commitment to patient welfare and clinical excellence in oncology diagnostics.
