RMH clonoSEQ® Assay

{
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      "title": "RMH clonoSEQ\u00ae Assay",
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      "identifier": {
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        "scheme": "GB-PPON"
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      "name": "Central London Community Healthcare NHS Trust",
      "roleDetails": "CLCH host a collaborative, outsourced procurement service - North West London Procurement Services.",
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    {
      "address": {
        "country": "US",
        "countryName": "United States",
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        "streetAddress": "1165 Eastlake Ave E, Seattle, United States"
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      "contactPoint": {
        "email": "dgalezowski@adaptivebiotech.com"
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  "tender": {
    "description": "The procurement of a next-generation sequencing (NGS)\u2013based 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).\nThe required goods and services include:\n\u2022 Provision of assay kits and reagents suitable for the intended patient population.\n\u2022 Use of a software platform for analysis and reporting of results.\n\u2022 Training and technical support for laboratory and clinical staff to ensure accurate sample processing, data interpretation, and integration into clinical workflows.\n\u2022 Ongoing technical support, maintenance, and updates for both hardware (if applicable) and software components.\n\u2022 Delivery of consumables and reagents on a schedule that aligns with clinical demand, ensuring continuity of patient testing.\n\u2022 Compliance with all relevant regulatory standards (e.g., CE-IVD, UKCA marking) and data protection requirements for patient information.\n\u2022 Optional: Integration with existing laboratory information management systems (LIMS) and electronic health records (EHR), if required.\n\u2022 MRD sensitivity threshold of 10-5 or lower\n\u2022 Must work on DNA\n\u2022 Performance data must be supported by evidence generated in relevant disease specific Clinical Trials\n\u2022 Recognised technology included in clinical guidelines\n\u2022 Ability to track clonal evolution",
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    "procurementMethod": "direct",
    "procurementMethodDetails": "Direct award",
    "procurementMethodRationale": "The supplier owns the IP for this assay. The unique factors are detailed below:\nUnique Capabilities:\n\u2022     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.\n\u2022     Standardization: clonoSEQ is a sole-source test. All reagents, materials, and equipment are needed to perform the assay.\n\u2022     FDA Approval: clonoSEQ is the first and only FDA-cleared assay for MRD detection ALL, CLL or MM.\n\u2022     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.\n\u2022     Clinical Guidelines: NGS MRD assessment is included in clinical guidelines for ALL, CLL, DLBCL, and multiple myeloma.\nMonitoring 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.",
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    "riskDetails": "Delayed supply",
    "status": "complete",
    "title": "RMH clonoSEQ\u00ae Assay"
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}