DA Grants Breakthrough Device Designation to DNAe’s Sequencing Diagnostic

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-SEQ™ 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 environments. The platform is based on novel, semiconductor sequencing, which uses a silicon chip to detect ions released in the step-by-step construction of nucleic acids, e.g. DNA.

The device will support a pipeline of rapid and cost-effective tests, including for infectious disease diagnostics, cancer, infection control, and preparedness and response for pandemics. In 2016, DNAe was awarded a contract with the Biomedical Advanced Research and Development Authority (BARDA*), worth up to $51.9 million if all options are awarded, to support development of the innovative platform initially for rapid diagnosis of antimicrobial resistant infections.