The Challenge
INFECTIOUS DISEASE AND ANTIMICROBIAL RESISTANCE
There is a growing urgency to tackle the alarming rise of antimicrobial resistance (AMR). AMR is one of the top global public health and development threats. contributing to 4.95 million deaths1. New forecasts indicate AMR will cause 39 million deaths between 2025 and 2050 – which equates to three deaths every minute. Studies project this will rise steadily in the coming decades, increasing 70% annually by 20502.
Testing plays a key role in reducing AMR by improving diagnosis of infections to prevent unwarranted use of antibiotics to treat blood stream infections (BSI) such as sepsis and to rapidly detect and contain resistant infections. The misuse of antibiotics can allow drug resistance to develop, therefore a timely diagnostic helps confirm the cause of an infection and guide patient management, reducing the instances of unwarranted antibiotic use. Rapid diagnosis of infections like sepsis are an urgent need as mortality increases 7.6% for every hour after onset of hypotension3.
Diagnostic solutions using fast and powerful genomic analyses
Capable of rapidly diagnosing infections and associated AMR at the point-of-need, our platform technology is uniquely positioned to respond to the AMR challenge.
The LiDia-SEQ™ system is a direct-from-specimen diagnostic platform that performs DNA sequencing on a microchip, to provide rapid, actionable information to clinicians. The user-friendly system can operate in a variety of environments at the point-of-need.
Our initial focus is on infectious disease diagnostics, where speed and microbial DNA sequence information can make the difference between life and death. This includes a range of tests, starting with a groundbreaking test for bloodstream infections (BSI) and antimicrobial resistance (AMR), which uses whole blood specimens to detect and identify infections that lead to sepsis. To follow this, we have a growing pipeline of tests for other healthcare applications where rapid point-of-need diagnostics are of critical need, including cancer testing and monitoring, and beyond.
IDENTIFY THE INFECTION FASTER
It can take 2-6 days to diagnose bloodstream infections using a blood culture test. Using our LiDia-SEQ™ sequencing system and BSI/AMR test, this can be achieved within hours, directly from raw whole blood specimens.
DNAe was awarded a contract worth up to $51.9M by the Biomedical Advanced Research and Development Authority (BARDA)*, to develop its semiconductor sequencing diagnostic platform initially for antimicrobial resistant infections in September 2016. The development program is on track with the Company achieving pivotal key milestones in 2024, with continued support in part from the company’s ongoing contract with BARDA. The data gathered demonstrates its potential as a game-changer in the BSI and sepsis field, as the first truly sample-to-result sequencing platform in the world, and the first solution to deliver the combination of a comprehensive clinically-actionable report directly from whole blood within a work shift. The company is in the latter stages of development and preparing for commercialization.
DNAe received “Breakthrough Device” designation from the US Food and Drug Administration (FDA) in 2020 for its pioneering platform and first test.
For Research Use Only. Not for use in diagnostic procedures. For illustrative purposes only.
