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Adaptive Biotechnologies Launches Assay Enhancements to Increase clonoSEQ® Sensitivity for Clinical MRD Detection in Diffuse Large B-Cell Lymphoma
Enhanced assay granted approval by New York State’s Clinical Lab Evaluation Program (CLEP)...
About this update from Adaptogenics Health Corp.
[{"type":"text","content":"Adaptive Biotechnologies Launches Assay Enhancements to Increase clonoSEQ® Sensitivity for Clinical MRD Detection in Diffuse Large B-Cell Lymphoma\n\n\n\n\n Enhanced assay granted approval by New York State’s Clinical Lab Evaluation Program (CLEP) for patients with DLBCL\n \n\n\n\n clonoSEQ is the only DLBCL MRD assay available for clinical use and covered by Medicare\n \n\n\n SEATTLE, March 11, 2025 (GLOBE NEWSWIRE) --  Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that it has launched an upgraded version of its clonoSEQ assay for measurable residual disease (MRD) detection in diffuse large B-cell lymphoma (DLBCL) using circulating tumor DNA (ctDNA).\n \n\n The enhanced clonoSEQ assay, which incorporates an optimized DNA extraction methodology and maximizes sample input, delivers a 7-fold increase in sensitivity. The assay leverages the same powerful technology as prior versions, detecting MRD by reading the full immune receptor sequence of the malignant B cells rather than relying on individual point mutations. Maintaining this proprietary approach enables improvements in sensitivity while preserving the exquisite specificity that minimizes risk of overtreatment due to false positives.\n \n\n The enhanced assay was previously made available for research use in November 2023 and is already being incorporated into both biopharma-sponsored and investigator-initiated prospective trials. Data generated using this assay and presented at ASH 2024 by Bond and colleagues demonstrated that in patients for which MRD was assessed by clonoSEQ, MRD negativity post-cycle six was highly prognostic of progression-free survival.\n \n\n “The enhancements to our clonoSEQ ctDNA-based DLBCL test offering strengthen the assay’s already-deep clinical sensitivity without compromising our unparalleled specificity,” said Susan Bobulsky, chief commercial officer, MRD, Adaptive Biotechnologies. “The assay’s strong performance on both fronts makes it possible to deliver accurate, actionable insights in the clinic and empowers drug developers to precisely target treatment intensification strategies for patients who remain MRD...