RMH clonoSEQ® Assay

Location

Description

The procurement of a next-generation sequencing (NGS)–based test assay designed for the detection and monitoring of minimal residual disease (MRD) in patients with certain haematologic malignancies, such as multiple myeloma, acute lymphoblastic leukaemia (ALL), and chronic lymphocytic leukaemia (CLL). The required goods and services include: • Provision of assay kits and reagents suitable for the intended patient population. • Use of a software platform for analysis and reporting of results. • Training and technical support for laboratory and clinical staff to ensure accurate sample processing, data interpretation, and integration into clinical workflows. • Ongoing technical support, maintenance, and updates for both hardware (if applicable) and software components. • Delivery of consumables and reagents on a schedule that aligns with clinical demand, ensuring continuity of patient testing. • Compliance with all relevant regulatory standards (e.g., CE-IVD, UKCA marking) and data protection requirements for patient information. • Optional: Integration with existing laboratory information management systems (LIMS) and electronic health records (EHR), if required. • MRD sensitivity threshold of 10-5 or lower • Must work on DNA • Performance data must be supported by evidence generated in relevant disease specific Clinical Trials • Recognised technology included in clinical guidelines • Ability to track clonal evolution

Award Detail

CPV Codes

• None found

Legal Justification

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.

Other Information

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