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SECAUCUS, N.J. - Quest Diagnostics (NYSE:DGX), a prominent $20.15 billion healthcare services provider generating over $10.5 billion in annual revenue, announced Monday that the U.S. Food and Drug Administration has granted Breakthrough Device Designation for its Haystack MRD test for identifying minimal residual disease in stage II colorectal cancer patients.
The designation applies specifically to identifying MRD-positive patients following surgical treatment who may benefit from adjuvant therapy in accordance with therapeutic product labeling. According to InvestingPro analysis, Quest maintains a strong market position in the Healthcare Providers & Services industry, with consistently profitable operations and healthy financial metrics.
The Breakthrough Devices Program is designed to accelerate development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions.
Quest introduced a clinical laboratory-developed version of Haystack MRD in late 2024 and is expanding access for oncologists and pharmaceutical partners.
"We are committed to working with the FDA and our research partners to validate the use of Haystack MRD in a variety of solid tumors," said Dan Edelstein, Vice President and General Manager, Haystack Oncology.
The test works by detecting circulating tumor DNA (ctDNA) in a patient’s bloodstream, which can reveal molecular evidence of disease recurrence months before it becomes apparent through conventional monitoring methods. According to a recent Harris Poll for Quest Diagnostics, 96% of oncologists surveyed believe MRD testing has potential to identify cancer recurrence earlier than current methods.
The test is currently used in multiple clinical trials and research studies with institutions in the U.S., Canada, and Australia, as well as by clinicians at over 75 cancer centers, academic centers, and health systems.
The information in this article is based on a press release statement from Quest Diagnostics.
In other recent news, Quest Diagnostics reported strong financial results for the second quarter of 2025. The company achieved adjusted earnings per share of $2.62, surpassing the projected $2.57. Additionally, Quest Diagnostics exceeded revenue expectations, bringing in $2.76 billion compared to the forecasted $2.73 billion. In another development, Baird downgraded Quest Diagnostics from Outperform to Neutral. The research firm cited a balanced risk/reward profile as the reason for this change, maintaining a price target of $194.00. Furthermore, Quest Diagnostics’ subsidiary, Haystack Oncology, announced a research collaboration with Mass General Brigham. This partnership will explore the use of liquid biopsy technology to guide post-surgical treatment decisions for cancer patients. The clinical trials will focus on specific types of skin and head and neck cancers.
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