The FDA has granted the breakthrough device designation for LiDia-SEQ along with its first assay, which is an advanced direct-from-specimen test
FDA grants breakthrough device designation to DNAe’s sequencing diagnostic. (Credit: Pixabay/Gerd Altmann)
DNA Electronics (DNAe), an advanced sequencing firm developing novel diagnostics, has secured the US Food and Drug Administration (FDA) Breakthrough Device designation for its LiDia-SEQ platform and a first assay.
The company has developed LiDia-SEQ as compact sequencing device, which can be operable by non-specialist users, enabling genomic analysis to address urgent medical needs.
DNAe president Samuel Reed said: “We are proud that the FDA has decided to grant Breakthrough Device designation to our LiDia-SEQ sequencing system and BSI/AMR test.
“This is testament to the growing recognition of the profound benefit our technology can offer to clinicians and patients. We look forward to working with the FDA and expediting development of our diagnostic to market.”
LiDia-SEQ will support cost-effective tests and diagnostics for infection control
The FDA has granted the breakthrough device designation for LiDia-SEQ along with its first assay, which is an advanced direct-from-specimen test for bloodstream infections (BSI) and antimicrobial resistance (AMR), to detect and identify infections.
The platform has been designed to rapidly detect and identify infectious agents and AMR markers directly from whole blood specimens, to enable faster treatment with targeted therapeutics.
The company said that its new platform has been built on advanced semiconductor sequencing, leveraging a silicon chip to detect ions released in the step-by-step construction of nucleic acids, including DNA.
The solution automates the entire process, from raw sample to actionable report, in a cartridge-contained, hands-free format, which can be used in diverse environments.
The device supports a range of quick and cost-effective tests, including for infectious disease diagnostics, cancer, infection control, and preparedness and response for pandemics.
DNAe has secured the Biomedical Advanced Research and Development Authority (BARDA) contract, worth up to $51.9m in 2016, to support the development of rapid diagnosis platform for antimicrobial resistant infections.
DNAe executive chairman and founder Christofer Toumazou said: “At a time when health systems are under acute pressure to deliver a rapid response to infectious agents, the vital need for improved diagnostic technologies is self-evident.
“DNAe’s direct-from-specimen sequencing technology can quickly identify infectious agents and AMR, providing insightful and actionable information to clinicians. By enabling the right treatment at the right time, we can help to save patient’s lives.”