Quest Diagnostics Launches Noninvasive Blood Test for Multiple Myeloma Residual Disease Monitoring
核心洞察
Quest Diagnostics has launched the Quest Flow Cytometry MRD for Myeloma (搜索) test, a noninvasive blood-based alternative to traditional bone marrow biopsies for monitoring residual disease in multiple myeloma (搜索) patients.
The test provides sensitivity comparable to next-generation sequencing methods while offering improved specimen stability of five days compared to conventional flow cytometry's three-day window.
The launch aligns with FDA draft guidance issued in January 2026 that supports using measurable residual disease as a primary endpoint in clinical trials for multiple myeloma (搜索) treatments.
Quest Diagnostics has launched a novel blood test that enables noninvasive monitoring of measurable residual disease (MRD) in multiple myeloma (搜索) patients across the United States. The Quest Flow Cytometry MRD for Myeloma (搜索) test uses advanced flow cytometry technology to detect small amounts of cancer cells that may remain in the body during or after treatment, offering a less invasive alternative to traditional bone marrow biopsies.
Technical Performance and Advantages
The new test provides sensitivity comparable to next-generation sequencing (NGS) methods in detecting residual myeloma, historically the standard for high-sensitivity detection that offers a tenfold improvement over conventional flow cytometry. However, NGS typically comes with a higher price point and requires a baseline aspirate sample taken before treatment to serve as a reference.
Quest's test achieves this high level of detection using noninvasive blood specimens instead of bone marrow aspirates and can be used in clinical situations where a baseline sample is not available. The test demonstrates improved specimen stability, remaining stable for five days compared to conventional flow cytometry that typically requires processing within three days or less. This extended window is designed to support testing access for patients even when specimen transport to a laboratory takes several days.
Clinical Context and Market Impact
Multiple myeloma (搜索) affects plasma cells (搜索), a type of white blood cell, and leads to the production of abnormal antibodies that impact the blood and bones. In the United States, approximately 36,000 new cases are diagnosed annually, and nearly 11,000 patients die from the disease each year. Monitoring MRD is essential for guiding personalized treatments, such as chemotherapy, as physicians manage the condition over the long term.
The launch comes at a strategically important time, as the Food and Drug Administration issued draft guidance in January 2026 regarding the use of MRD as a primary endpoint in clinical trials for multiple myeloma (搜索) treatments. This guidance suggests that MRD data can be used to support accelerated approval for new drug and biological products.
Development and Validation
The development and performance of the Quest Flow Cytometry MRD for Myeloma (搜索) test were presented at a recent American Society of Hematology (搜索) (ASH) Annual Meeting and Exposition, where medical community members were educated on how the assay could improve the treatment paradigm for patients with cancer. Beyond its role in routine clinical care, the test is expected to be utilized as a tool for monitoring patient response within clinical trials.
Access and Implementation
Quest Diagnostics operates approximately 7,000 phlebotomy sites across the United States, allowing patients with cancer to access the test in a variety of clinical settings. The company serves one in three adult Americans and half of the physicians and hospitals in the country. This infrastructure supports the safe collection and transport of specimens, ensuring that diagnostic insights are delivered to healthcare providers.
The noninvasive nature of the test addresses a significant clinical need, as traditionally assessing measurable residual disease requires a bone marrow aspirate, which is a type of biopsy. By utilizing advanced flow cytometry on blood specimens, this test provides a less invasive option for patients who require regular monitoring as they manage myeloma as a chronic condition.
This new offering complements Quest's broad portfolio of hematopathology and molecular oncology services, including the Haystack MRD test (搜索) for solid tumor cancers, positioning the company to support the growing demand for precision oncology monitoring tools.