World's First NGS-Based Diagnostic Platform Fully Automates Sample-To-Result Process Within Single Device

Now, a direct-from-specimen platform that performs genomic analysis on a microchip could provide comprehensive, actionable information to clinicians in a matter of hours, versus days.

DNAe’s (London, UK) next-generation sequencing (NGS)-based diagnostic platform – LiDia-SEQ – is the world's first system to fully automate the sample-to-result process within a single device. Until now, clinicians have had to trade off the speed and relative ease of use of conventional assays against the information richness, complexity, and unwieldiness of NGS. DNAe’s semiconductor sequencing-based diagnostic platform bridges this gap by enabling analysis and read-out on a single silicon chip, and running directly from the specimen in a rapid, easy-to-use format.

There is no need to measure optical signals or use lasers and microscopes. The LiDia-SEQ can perform a range of genomic analyses to deliver fast, accurate, and insightful diagnoses. Offering a low limit of detection and dramatically faster time-to-result than current lab-based blood culture testing, this rapid, point-of-need diagnostic platform will deliver near-patient NGS testing capabilities to medical teams working across hospitals, STAT labs, and clinics.

DNAe's initial focus is on infectious disease diagnostics, starting with a groundbreaking test for bloodstream infections (BSI) and antimicrobial resistance (AMR), which uses whole blood specimens to directly detect and identify infections that lead to sepsis. The BSI/AMR test can identify target microorganisms at very low concentrations of ≤3 CFU/mL and associated AMRs directly from a whole blood sample. The initial test is expected to offer a comprehensive testing menu of ~7,200 bacteria, with ~ 30 associated AMRs, and ~750 fungi.

This breakthrough test will be the first to be commercially launched and is intended for use in patients suspected of having bloodstream infections/sepsis. This will provide clinicians with actionable information to help select the appropriate antibiotics to treat the disease. A pipeline of follow-on tests is in development for viruses and cancer testing and monitoring.

By detecting bacterial pathogens (and associated AMR profile) plus fungal pathogens directly from whole blood samples – at the point-of-need and within hours versus days – DNAe's technology is set to facilitate rapid and accurate testing of patients suspected of serious infections and unlock game-changing testing capabilities in infectious diseases, cancer detection, and beyond.

"Our focus now is on completing the development of our flagship BSI/AMR test on the LiDia-SEQ platform – a highly sensitive, fully automated test from whole blood samples that will enable rapid detection and identification of life-threatening infections, bringing unprecedented insights to clinicians when every minute matters," said Samuel Reed, CEO of DNAe.

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