Clinical Laboratory Molecular Diagnostics Test using InvivoScribe Reagents Kit
NATIONAL INSTITUTES OF HEALTH
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The National Institutes of Health (NIH), Office of Acquisition and Logistics Management, is intending to negotiate a sole source contract for InvivoScribe molecular diagnostics test reagents and kits. The Molecular Diagnostics Laboratory of the Laboratory of Pathology uses these kits to perform molecular testing for the diagnosis of various cancers. These tests assist in pathologic diagnosis, predict prognosis, and identify potential targets for personalized therapies. The laboratory is CLIA and College of American Pathology approved for molecular oncology testing on NIH patients. The InvivoScribe IgH +IgK B-cell clonality Assays are used for the identification of clonal immunoglobulin gene rearrangements, useful in detecting B-cell malignancies, determining leukemia and lymphoma lineage, and monitoring disease recurrence. The Specimen Size Control Ladder is used to determine the quality of patient DNA samples by identifying amplifiable fragmented DNA. This acquisition is being conducted under Simplified Acquisition Procedures (FAR Part 13) and is not expected to exceed the simplified acquisition threshold. The NAICS code for this procurement is 541990, with a size standard of $19,500,000.
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