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Vela Diagnostics Lists NGS System as Class II Medical Device with FDA

NEW YORK (GenomeWeb) – Vela Diagnostics said today that it has completed the listing of its next-generation sequencing system with the US Food and Drug Administration as a class II medical device.

The diagnostic system includes the Sentosa ST401 instrument for automated template preparation and enrichment, the Sentosa SQ301 sequencer and server, and the Sentosa SQ Reporter for data analysis and report generation.

"Due to a lack of automation and sample traceability, as well as the generation of large amounts of data, which require advanced molecular biology and informatics skills, NGS technology has so far been perceived to be of limited use in the routine laboratory, " Vela Diagnostics CEO Michael Tillmann said in a statement. "Vela Diagnostics provides the answer to these challenges by offering an automated workflow."

The SQ301 sequencer is based on Thermo Fisher's Ion Torrent semiconductor sequencing technology. Thermo Fisher manufactures the instrument, but does so according to specifications by VelaDx. Previously, VelaDx said it intended to launch CE-IVD marked clinical assays on the system.