Adaptive Biotechnologies Launches Assay Enhancements to Increase clonoSEQ® Sensitivity for Clinical MRD Detection in Diffuse Large B-Cell Lymphoma

Core Viewpoint - Adaptive Biotechnologies has launched an enhanced version of its clonoSEQ assay for measurable residual disease (MRD) detection in diffuse large B-cell lymphoma (DLBCL), which is now approved for clinical use in New York State and covered by Medicare [1][4]. Group 1: Product Enhancements - The enhanced clonoSEQ assay features an optimized DNA extraction methodology and maximizes sample input, resulting in a 7-fold increase in sensitivity [2]. - The assay maintains its proprietary approach by reading the full immune receptor sequence of malignant B cells, which improves sensitivity while preserving specificity, thus minimizing the risk of overtreatment due to false positives [2][4]. Group 2: Clinical Impact - The enhanced assay was previously available for research use and is being incorporated into biopharma-sponsored and investigator-initiated trials, with data indicating that MRD negativity post-cycle six is highly prognostic of progression-free survival [3][6]. - The assay has been used to manage and inform patient care for over 2,800 DLBCL patients, with more than 640 providers utilizing it in 2024 alone [4]. Group 3: Market Context - DLBCL is the most common form of non-Hodgkin lymphoma in the U.S., accounting for about 1 in 3 NHL patients, with over 18,000 new diagnoses each year [5]. - Approximately 30-40% of DLBCL patients experience relapse, primarily within the first two years, highlighting the importance of MRD testing for assessing treatment response and adjusting treatment plans [5][6]. Group 4: Regulatory and Clinical Guidelines - The New York State Department of Health has approved the enhanced clonoSEQ ctDNA assay for MRD detection in DLBCL, aligning with updated National Comprehensive Cancer Network (NCCN) guidelines recommending ctDNA testing for MRD assessment in PET-positive DLBCL patients [4].