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  • Reagents intended to generate data for multiple analytes using two or more in vitro diagnostic test types (e.g., DNA sequence analysis, protein expression analysis, RNA expression analysis). These tests typically employ a predetermined analytic algorithm. The algorithm uses the results of the in vitro diagnostic tests as inputs and generates a score as output. Some multimodal assays may also include as algorithm inputs additional data (e.g., patient age, patient menopausal status, previously generated cytology results). Depending on the multimodal assay, the algorithm-generated score may be reported as a binary output (e.g., positive or negative for disease of interest) or as a probability (e.g., likelihood of disease progression/recurrence).
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