RMH clonoSEQ® Assay · UK public procurement notice

The supplier owns the IP for this assay. The unique factors are detailed below:

Unique Capabilities:

• Sensitivity: clonoSEQ can detect MRD down to one cancer cell among a million healthy cells, deeper than flow cytometry or PCR. This level of sensitivity is critical for accurately assessing MRD in patients for both depth of response and early relapse detection.
• Standardization: clonoSEQ is a sole-source test. All reagents, materials, and equipment are needed to perform the assay.
• FDA Approval: clonoSEQ is the first and only FDA-cleared assay for MRD detection ALL, CLL or MM.
• Comprehensive Data Analysis: The assay includes sophisticated bioinformatics tools that offer detailed insights into clonal evolution and disease progression, which are not available with other MRD testing methods, resulting in a tracking report of disease burden over time.
• Clinical Guidelines: NGS MRD assessment is included in clinical guidelines for ALL, CLL, DLBCL, and multiple myeloma.

Monitoring MRD is crucial for assessing the treatment effectiveness and early detection of relapse in patients with lymphoid malignancies, including acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and multiple myeloma (MM). Traditional methods, such as flow cytometry and polymerase chain reaction (PCR), lack the sensitivity and standardisation required for consistent and deep MRD detection across different laboratories and clinical settings. The clonoSEQ Assay was developed by Adaptive Biotechnologies in accordance with CLIA/College of American Pathologists (CAP) requirements. Adaptive Biotechnologies is a single-source provider of the clonoSEQ Assay and therefore is uniquely positioned to meet the MRD detection needs for patients.