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  • In vitro diagnostic tests intended to determine the sequence of nucleotides comprising the protein-coding portion of the human genome (i.e., the exome) of an individual or individuals, which encompasses approximately 1.5% of the genome. These tests consist of a series of steps including fragmentation of the genomic DNA to be sequenced; library creation consisting of amplification of fragmented DNA and capture of exomic targets (typically by array-based or in-solution hybridization); sequence generation; and computational analysis (i.e., mapping, alignment, and variant calling).
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