FDA Grants Breakthrough Device Designation to DNAe´s Sequencing Diagnostic
(WorldNews Business)

LONDON & CARLSBAD, Calif.--(BUSINESS WIRE)--Apr 9, 2020-- DNAe, the next generation sequencing company developing novel diagnostics for use at the point-of-need, today announced that the US Food and Drug Administration (FDA) has granted it a `Breakthrough Device` designation for its pioneering platform and first assay. DNAe has reinvented sequencing in order to develop a compact device operable by non-specialist users. LiDia-SEQTM will, for the first time, bring genomic analysis into use at the point-of-need to meet urgent medical needs. The entire process is automated, from raw sample through to actionable report, in a cartridge-contained, hands-free format, and can be used in diverse...