DNAe

DNAe is a molecular diagnostics company focused on applying semiconductor sequencing technology to healthcare challenges where rapid, point-of-need results are critical.

The company was established in 2003 as a spin-out from Imperial College London by Professor Chris Toumazou. Toumazou, a distinguished biomedical engineer, invented a method of using a standard silicon chip to detect the ions released during DNA synthesis, enabling a purely electronic, optics-free approach to sequencing. This foundational technology was motivated by a personal drive to apply semiconductor solutions to healthcare, a field in which he holds over 50 patents. DNAe's journey began with a focus on R&D and licensing, with its semiconductor sequencing technology being licensed to Thermo Fisher and forming the core of the Ion Torrent™ Next Generation Sequencing (NGS) systems. The firm has since evolved into a product-focused company, backed by investors including Malaysian-based global investor Genting Berhad.

DNAe is developing the LiDia-SEQ™ platform, a compact, user-friendly diagnostic system designed to perform genomic analysis on a microchip directly from a raw patient sample. The entire process, from sample insertion to an actionable report, is automated within a single-use cartridge, making it suitable for use by non-specialists in various hospital environments like STAT labs and clinics. The system aims to bridge the gap between the speed of conventional assays and the rich data of traditional, more complex NGS methods. The business generates revenue through the eventual sale of these diagnostic platforms and the associated test cartridges. A significant milestone was the award of a contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) in 2016, worth up to $51.9 million, to develop this platform for antimicrobial resistant infections. The company also received FDA Breakthrough Device Designation for the LiDia-SEQ platform and its first assay.

The company's primary product is the LiDia-SEQ™ system, which is currently for research use only and not for use in diagnostic procedures. Its initial test is focused on identifying bloodstream infections (BSI) and antimicrobial resistance (AMR) markers, which are precursors to sepsis. This test can deliver results from a whole blood sample in approximately 3-4 hours, a significant reduction from the 2-6 days required for traditional blood cultures. This rapid turnaround enables clinicians to make timely, informed decisions on targeted antibiotic treatments. Beyond sepsis, DNAe is actively developing a pipeline of other tests for its platform, including diagnostics for other infectious diseases and applications in cancer testing and monitoring.

Keywords: point-of-need diagnostics, semiconductor sequencing, molecular diagnostics, next-generation sequencing, infectious disease diagnostics, sepsis testing, antimicrobial resistance, LiDia-SEQ, genomic analysis, microchip DNA sequencing, direct-from-specimen, blood-to-result platform, Chris Toumazou, medical diagnostics, biotech, rapid diagnostics, bloodstream infections, cancer monitoring, clinical diagnostics, point-of-care testing