Tender: NGS Sample-to-Report Solution for CLL Stratification, MRD and AML Testing

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The Coordinating Entity is seeking a supplier for a Next Generation Sequencing (NGS)-based sample-to-report product that meets or exceeds the stated requirements. The solution must provide an all-in-one NGS assay for chronic lymphocytic leukemia (CLL) analysis and stratification including identification of IGH rearrangements, IGH clonality and IGHV somatic hypermutation; detection of single nucleotide variants (SNVs), insertions/deletions (indels) and copy number variants (CNVs) for multiple genes including BCL2, NOTCH1, SF3B1 and TP53; and identification of cytogenetic alterations including del17p, del11q and trisomy 12. The product must also provide a solution for minimal residual disease (MRD) testing and a solution for acute myeloid leukemia (AML) testing, and comply with all additional specifications set out in Section 4 – Product / Services.