Agilent Launches TapeStationDx Systems for Clinical NGS Sample Quality Control

Agilent Technologies is extending its automated electrophoresis portfolio into regulated clinical laboratories with the launch of its CE-IVD-marked TapeStationDx systems and software. These new instruments are designed to support Next-Generation Sequencing (NGS) workflows in regulated environments, providing standardized and traceable quality control for DNA and RNA samples.

Agilent is among the first providers to offer CE-IVD-marked automated electrophoresis solutions for clinical NGS sample quality control in its launch regions. This launch addresses the rapid expansion of clinical NGS diagnostics and the increasing demand for compliance with regulatory expectations, such as the European Union's In Vitro Diagnostic Regulation (IVDR).

Clinical laboratories often handle valuable and limited human specimens. Poor sample quality can lead to delayed sequencing, necessitate repeat analyses, and prolong the time it takes to receive patient results. The TapeStationDx systems help assess sample quality through automated workflows designed to reduce manual errors, ensure consistent operation, and enable informed 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 Agilent's Life Sciences and Diagnostics Group. "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, analyzing 1 to 16 samples. The 4200 TapeStationDx system offers scalable throughput for 1 to 96 samples. Both systems provide fast, automated sample quality control in approximately 1 to 2 minutes per sample. The accompanying software supports data integrity and regulatory compliance, including audit trail and electronic signature features to aid adherence to regulations such as 21 CFR Part 11 and EU Annex 11.