Agilent Launches CE-IVD TapeStationDx Systems for Clinical NGS Quality Control

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Agilent Technologies Inc. announced the launch of the Agilent 4150 TapeStationDx system, the Agilent 4200 TapeStationDx system and Agilent TapeStationDx software, extending its automated electrophoresis portfolio into regulated clinical laboratory environments. The new CE-IVD-labeled systems and software are designed to support standardized and traceable quality control of DNA and RNA samples used in clinical next-generation sequencing workflows, and Agilent said it is among the first providers to offer CE-IVD-labeled automated electrophoresis solutions for clinical NGS sample quality control in the launch regions. The 4150 TapeStationDx system supports lower-throughput laboratories with the flexibility to analyze 1 to 16 samples using tube strips, while the 4200 TapeStationDx system provides scalable throughput from 1 to 96 samples using either tube strips or 96-well plates at a constant cost per sample, with both systems delivering automated sample quality control in approximately 1 to 2 minutes per sample. The accompanying TapeStationDx software controls data acquisition and analysis and includes reporting and data export capabilities, with data integrity features such as audit trails and electronic signatures to help laboratories support compliance with regulations including 21 CFR Part 11 and EU Annex 11. The systems and software are available in the United States, Canada and select European markets including Austria, Belgium, Luxembourg, Switzerland, Germany, Denmark, Spain, Finland, France, the United Kingdom, Ireland, Italy, the Netherlands and Sweden, and Agilent will showcase the portfolio at the Italian Society of Human Genetics National Congress, the American Society of Human Genetics Annual Meeting and the Association for Molecular Pathology Annual Meeting.

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