Thermo Fisher Scientific introduces IVDR-compliant capillary electrophoresis system
Thermo Fisher Scientific has launched the Applied Biosystems SeqStudio Flex Dx Genetic Analyzer, a new IVDR-compliant capillary electrophoresis system designed to support clinical laboratories with enhanced workflow efficiency, regulatory compliance, and scheduling flexibility for both Sanger sequencing and fragment analysis applications.
Addressing clinical laboratory challenges
The SeqStudio Flex Dx arrives at a time when clinical and hospital laboratories face mounting pressure to deliver accurate results with accelerated turnaround times. The system addresses these challenges by offering three distinct operating modes – In Vitro Diagnostic Use (IVD), Investigational Use Only (IUO), and Research Use Only (RUO) –allowing laboratories to seamlessly transition between development, validation, and diagnostic testing workflows.
“Clinical or hospital laboratories commonly struggle with time-sensitive demands which include the need for accurate results, faster time-to-answer workflows, and the training required to use diagnostic instruments,” notes Thermo Fisher in its announcement.
Technical specifications enhance throughput
Available in both 8- and 24-capillary configurations, the system features a four-plate capacity design that permits continuous plate loading with auto-spectral calibration. Notably, the platform allows for urgent sample reprioritisation, providing laboratories with unprecedented scheduling flexibility.
The instrument’s intuitive design incorporates easy capillary array installation and streamlined one-button startup procedures, significantly reducing training requirements in multi-user environments.
Enhanced connectivity and data management
Laboratory integration has been prioritised with compatibility forlaboratory information management systems (LIMS), which the company states “increases data quality.” Additionally, the Thermo Fisher Connect Platform enables remote instrument monitoring and data access, facilitating collaboration across distributed teams.
“The SeqStudio Flex Dx brings a deeper level of workflow integration and ease-of-use to Thermo Fisher’s trusted CE platform, delivering schedule flexibility, improved connectivity and data quality, and updated integration with regulated workflows,” the company explains.
European regulatory compliance
The system has been designed with IVDR compliance as a cornerstone feature, enabling seamless clinical workflows with validated IVD consumables. Currently, the platform is available across multiple European markets including the UK, Germany, France, Italy, Spain, Austria, Czech Republic, Belgium, Sweden, Norway, Denmark, Poland, Ireland, Netherlands, Luxembourg, and Oman.
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For more information, visit:
https://www.thermofisher.com/us/en/home/life-science/sequencing/sanger-sequencing/genetic-analyzers/models/seqstudio-flex-dx.html
