— Thermo Fisher Scientific, the world leader in serving science, has announced the launch of the Applied Biosystems™ SeqStudio™ Flex Dx Genetic Analyzer, an advanced IVDR-compliant capillary electrophoresis (CE) system engineered to meet the rigorous demands of modern clinical laboratories. The system is designed to deliver flexible workflows, superior ease of use, and seamless regulatory compliance across both diagnostic and research applications.

With a rapidly evolving healthcare landscape, clinical and hospital laboratories are under increasing pressure to deliver accurate and timely genomic testing results while navigating stringent regulatory standards. The SeqStudio Flex Dx offers a solution to these challenges with built-in workflow versatility, integrated smart connectivity, and intuitive operation that reduces training time and increases diagnostic efficiency.

Clinical laboratories are facing growing demands to accelerate turnaround times while ensuring compliance. The SeqStudio Flex Dx addresses these needs head-on, enabling labs to confidently transition between research and diagnostic workflows with a single, reliable platform.

Key Features and Benefits:

• IVDR Compliance: Supports validated IVD consumables and SAE, streamlining regulatory compliance for clinical workflows across Europe and select global markets.

• Three Operating Modes: Offers In Vitro Diagnostic (IVD), Investigational Use Only (IUO), and Research Use Only (RUO) modes to accommodate assay development, investigational studies, and clinical testing—all within a single instrument.

• Flexible Throughput Options: Available in 8- and 24-capillary configurations, with four-plate capacity, urgent sample reprioritization, and continuous plate loading to maximize operational efficiency.

• Smart Connectivity: Seamless integration with Laboratory Information Management Systems (LIMS) and Thermo Fisher Connect Platform enables remote monitoring and enhanced collaboration across teams.

• User-Centric Design: One-button startup, easy capillary array installation, and an onboard learning center offer simplified training and usability in both single- and multi-user settings.

The SeqStudio Flex Dx empowers a broad range of users—from clinical labs and reference centers to assay developers and research institutions—by supporting targeted genomic testing for Sanger sequencing and fragment analysis.

Available Regions:

The system is currently available in Italy, France, Germany, Spain, UK, Austria, Czech Republic, Belgium, Sweden, Norway, Denmark, Poland, Ireland, Netherlands, Luxembourg, and Oman.