Core Insights - Quest Diagnostics has received Breakthrough Device Designation from the FDA for its Haystack MRD® test, aimed at identifying MRD-positive patients with stage II colorectal cancer post-surgery who may benefit from adjuvant therapy [1][3] - The Haystack MRD test is supported by a growing body of research indicating its effectiveness in detecting residual or recurrent cancer from solid tumors, enhancing both clinical and pharmaceutical applications [2][4] Company Overview - Quest Diagnostics is a leading provider of diagnostic information services, serving one in three adult Americans and half of the physicians and hospitals in the U.S. [6] - The company emphasizes the importance of diagnostic insights derived from laboratory testing to improve health outcomes and empower healthcare decisions [6] Product Details - Haystack MRD is a liquid biopsy test designed to detect low levels of circulating-tumor DNA (ctDNA) in the bloodstream, which can indicate residual, recurrent, or resistant disease in cancer patients [5] - The test has been utilized in multiple clinical trials and is available for clinical use across over 75 top cancer and academic centers [5] Research and Development - The Breakthrough Devices Program aims to expedite the development and approval of medical devices that provide effective treatment or diagnosis for life-threatening conditions, which aligns with the goals of Quest Diagnostics in advancing the Haystack MRD test [3] - A recent survey indicated that 96% of oncologists believe MRD testing can identify cancer recurrence earlier than current methods, highlighting the test's potential impact on clinical practices [4]