Agilent launches CE-IVD-labeled systems for clinical NGS quality control

Agilent Technologies (NYSE: A) has launched two new automated electrophoresis systems and accompanying software designed for clinical next-generation sequencing (NGS) sample quality control in regulated laboratory environments, according to a company statement.

The Agilent 4150 TapeStationDx and 4200 TapeStationDx systems, along with TapeStationDx software, carry CE-IVD labeling, which is required under the European In Vitro Diagnostic Regulation (IVDR). The products are available in the United States, Canada and select European markets.

The 4150 system supports analysis of 1 to 16 samples using tube strips, while the 4200 system scales from 1 to 96 samples using tube strips or 96-well plates. Both systems process samples in approximately one to two minutes each. The TapeStationDx software includes audit trails and electronic signatures intended to support compliance with regulations such as 21 CFR Part 11 and EU Annex 11.

"Clinical laboratories are increasingly relying on genomic information to support patient care decisions," said Knut Wintergerst, vice president and general manager of the Life Sciences and Diagnostics Group at Agilent. "TapeStationDx extends our established TapeStation technology into regulated clinical environments, helping laboratories implement standardized quality control workflows with the consistency and traceability required for clinical NGS."

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 company plans to showcase the TapeStationDx portfolio at the American Society of Human Genetics Annual Meeting in Montreal in October 2026 and the Association for Molecular Pathology Annual Meeting in Seattle in November 2026.

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