Thermo Fisher Scientific launches new IVDR-compliant capillary electrophoresis instrument
The new genetic analyzer supports both clinical as well as research for Sanger sequencing and fragment analysis in targeted genomic testing
4 Apr 2025
Designed to meet the needs of clinical laboratories by offering compliance to regulatory mandates, efficiency, ease of use, and run schedule flexibility, Thermo Fisher Scientific is introducing the Applied Biosystems™ SeqStudio™ Flex Dx Genetic Analyzer. SeqStudio Flex Dx is an IVDR-compliant capillary electrophoresis (CE) system that supports both clinical as well as research for Sanger sequencing and fragment analysis in targeted genomic testing.
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. Designed to help laboratories stay compliant amid this fast-paced environment, the SeqStudio Flex Dx offers flexible modes and features, allowing laboratories to streamline their workflows and spend more time focused on diagnostics.
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.
Key Applications:
Clinical labs, reference labs, hospital labs, clinical assay developers, and clinical research labs
Regions:
Italy, France, Germany, Spain, UK, Austria, Czech Republic, Belgium, Sweden, Norway, Denmark, Poland, Ireland, Netherlands, Luxembourg, Oman
Features:
- IVDR compliance: Enables seamless clinical workflow with validated IVD consumables and SAE
- Three operating modes to support various workflows: In Vitro Diagnostic Use (IVD), Investigational Use Only (IUO) and for use in performance evaluation studies, and Research Use Only (RUO) modes allow for development and validation, investigational use, and diagnostic testing to enable regulatory compliance and increase efficiency through ease of use and flexibility
- Intuitive design and time-saving features: Available in both 8- and 24-capillary configurations, the SeqStudio Flex Dx is designed with clinical labs in mind. Four-plate capacity, continuous plate loading with auto-spectral calibration capabilities and urgent sample reprioritization for both mid-throughput capacity and scheduling flexibility translate to extra time savings
- Smart lab connectivity: Compatibility with laboratory information management systems (LIMS) increases data quality while the Thermo Fisher Connect Platform provides enhanced flexibility and simplified collaboration by allowing users to stay connected to their instrument and data, remotely, from nearly anywhere
- Ease of use: Easy capillary array installation, streamlined one-button startup, and an onboard learning center offer users exceptional usability and streamlined training whether they work in a single- or multi-user environment
