New CE-IVD-labeled systems and software bring established TapeStation technology to regulated clinical laboratory workflows
SANTA CLARA, Calif.–(BUSINESS WIRE)–Agilent Technologies Inc. (NYSE: A) today announced the launch of the Agilent 4150 TapeStationDx system, Agilent 4200 TapeStationDx system and Agilent TapeStationDx software, extending the company’s 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 (NGS) workflows.
Agilent is among the first providers to offer CE-IVD-labeled automated electrophoresis solutions for clinical NGS sample quality control in the launch regions, at a time when clinical NGS is expanding rapidly and laboratories face increasing regulatory expectations, including the In Vitro Diagnostic Regulation (IVDR) in Europe.
Clinical laboratories often work with valuable, limited human specimens, where poor DNA and RNA sample quality can delay downstream sequencing, require repeat analysis, and prolong the wait for patient results. TapeStationDx systems help laboratories assess sample quality through automated workflows designed to reduce manual errors, support consistent operation, and enable informed sample decisions before sequencing.
“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.”
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. Both systems deliver fast, 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. Its data integrity features, including audit trails and electronic signatures, help laboratories support compliance with regulations such as 21 CFR Part 11 and EU Annex 11.
The Agilent TapeStationDx 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.
Agilent will showcase the TapeStationDx portfolio at upcoming industry events, including the Italian Society of Human Genetics (SIGU) National Congress (Oct. 7-9, 2026, Rimini), the American Society of Human Genetics (ASHG) Annual Meeting (Oct. 20-24, 2026, Montreal) and the Association for Molecular Pathology (AMP) Annual Meeting (Nov. 10-14, 2026, Seattle).
For In Vitro Diagnostic Use Only.
About Agilent Technologies
Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers’ most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.
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