Quest Resource Holding (DGX) Achieves Breakthrough FDA Designation for Haystack MRD Cancer Test
- Quest Diagnostics receives FDA Breakthrough Device Designation for the Haystack MRD® test targeting colorectal cancer post-surgery.
- The Haystack MRD test aims to enhance early detection of cancer recurrence and improve treatment decision-making.
- Quest Diagnostics continues to innovate in diagnostics, positioning itself as a leader in personalized cancer care solutions.
Quest Diagnostics Advances Cancer Monitoring with Breakthrough Device Designation
Quest Diagnostics (NYSE: DGX) secures a significant milestone in cancer diagnostics as the U.S. Food and Drug Administration (FDA) grants Breakthrough Device Designation for its Haystack MRD® test. This innovative test targets the detection of minimal residual disease (MRD) in stage II colorectal cancer patients following surgery. By identifying patients who may benefit from adjuvant therapy, the Haystack MRD test aims to transform the post-surgical landscape of colorectal cancer treatment. The FDA's designation underscores the increasing reliance on ctDNA-based MRD tests in monitoring residual or recurrent cancer in solid tumors, indicating a shift towards more precise and personalized patient care.
Launched as a clinical laboratory-developed test in late 2024, the Haystack MRD test is now poised for broader adoption among oncologists and pharmaceutical collaborators. Dan Edelstein, Vice President and General Manager of Haystack Oncology at Quest, highlights the company's dedication to refining this test in partnership with the FDA and research institutions. This collaboration aims to validate the Haystack MRD test's efficacy across a range of solid tumors, ultimately enabling tailored monitoring of treatment responses. As evidence mounts regarding the effectiveness of ctDNA MRD tests in detecting early signs of cancer recurrence, the Haystack MRD test stands to enhance clinical decision-making significantly.
Research supporting the Haystack MRD test reveals its potential to detect tumor-derived DNA in the bloodstream, offering insights into cancer recurrence long before conventional imaging techniques can. A recent Harris Poll survey reinforces this perspective, with 96% of oncologists acknowledging that MRD testing can facilitate earlier identification of recurrences compared to existing methodologies. The development of the Haystack MRD test, backed by a team of experts in cancer genomics and liquid biopsy, aims to deliver a highly sensitive and specific tool for assessing patients' cancer status, thereby allowing healthcare professionals to make more informed treatment adjustments and improve patient outcomes.
In addition to its groundbreaking MRD test, Quest Diagnostics continues to expand its portfolio of diagnostic services to enhance patient care across various medical fields. The company's ongoing commitment to innovation in diagnostic technology positions it as a leader in providing critical information that informs treatment decisions and improves healthcare delivery.
As the healthcare landscape evolves, Quest Diagnostics remains at the forefront of integrating advanced diagnostics into clinical practice. The Haystack MRD test exemplifies the potential for personalized medicine in oncology, reflecting a broader trend towards more precise, data-driven treatment strategies in the fight against cancer.