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Thermo Fisher Scientific Receives CE-IVD Mark for NGS Aneuploidy Diagnostic Software Workflows

NEW YORK – Thermo Fisher Scientific said on Wednesday that it has received CE-IVD marking for its Ion Torrent Reporter Software Aneuploidy Dx Workflows.

The CE-IVD Mark covers two workflows: low-pass whole-genome aneuploidy Dx w1.0 and low-pass whole-genome aneuploidy Mosaic Dx 1.0. These workflows are to be used in combination with general, non-in vitro diagnostic products, including the Ion Torrent GeneStudio S5 sequencing system and the Ion Chef system, among others. The workflows are registered for detection of aneuploidies, including trisomy 21.

"The CE-IVD mark obtained by Thermo Fisher is another step towards expanding the use of next-generation sequencing in clinical settings to offer non-invasive methods for screening embryos to improve in vitro fertilization outcomes," a Thermo Fisher spokesperson said in an email.

This is the latest sequencing-related regulatory approval for Carlsbad, California-based Thermo Fisher. In March, the firm obtained CE-IVD marking for the Ion Torrent Genexus Dx Integrated Sequencer.

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