RMH clonoSEQ® Assay

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