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.
Display your AMR Technology, Product and Service
Suppliers and Users of Technologies, Products and Services benefit from CAPI.
CAPI (Continuous AMR Partnering Initiative) unites Suppliers and Users worldwide with the aim to add to the curbing of AMR.