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Ion Torrent Reporter Software Aneuploidy Dx Workflows Receive CE-IVD (IVDD) Mark


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As part of its commitment to making next-generation sequencing (NGS) solutions available for clinical use, Thermo Fisher Scientific has received a CE-IVD (IVDD) Mark for its Ion Torrent Reporter Software Aneuploidy Dx Workflows.* The workflows are registered for detection of aneuploidies, including trisomy 21 under Annex II List B of the In Vitro Diagnostic Medical Devices Directive (IVDD). 


The Ion Torrent Reporter Software Aneuploidy Dx Workflows provide qualitative determination of aneuploidies, including trisomy status of chromosome 21, in genomic DNA derived from human cells using NGS. The detection of aneuploidies is intended for screening embryos to improve in vitro fertilization (IVF) outcomes.


The CE-IVD (IVDD) mark covers two workflows: low-pass whole-genome aneuploidy Dx w1.0 and low-pass whole-genome aneuploidy Mosaic Dx 1.0. The Aneuploidy Dx Workflows are to be used in combination with ancillary general lab products (non-IVD) including the Ion Torrent GeneStudio S5 system, Ion Chef System, Ion ReproSeq PGS reagents and consumables, Torrent Suite Software, Ion Reporter Software and server. 


Key Applications: 


Genetic testing labs, IVF clinics and hospital systems conducting pre-implantation genetic testing. 


Features/Benefits: 

  • Scalable: enable simple, end to end runs for the detection of aneuploidies across all 24 chromosomes.  
  • Robust detection: Low pass whole-genome amplification with option for intermediate chromosome copy number (mosaicism) detection.  
  • Rapid, cost-effective results: Returns results within a day. 
  • Intuitive Software: Simple interpretation of aneuploidies and mosaicism.  

*For In Vitro Diagnostic Use. Not available in all countries including the United States.  

  

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