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The Sentosa SQ HCV Genotyping Assay (VELA Diagnostics GmbH, Hamburg, Germany) is a novel deep sequencing-based in vitro diagnostic test comprising a customized version of the epMotion 5075 robotic liquid handling system for RNA extraction and sequence library preparation (Sentosa SX101), a customized version of an Ion One Touch device for template preparation including emulsion PCR (Sentosa ST401), the Ion Torrent technology for deep sequencing (Sentosa SQ301), and software for data analysis and reporting (Sentosa Link and Sentosa Reporter, respectively)

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When the 503B rule is finalized, whenever that happens, nothing about our patients' supply changes

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