Internal Testing Underway of the LiDia-SEQ™ Technology for SARS-CoV-2

London, UK and Carlsbad, CA, USA – 9 April 2020 – DNAe, the next generation sequencing company developing novel diagnostics for use at the point-of-need, today provides an update on its response to the COVID-19 pandemic and announces that internal testing is underway to evaluate use of the LiDia-SEQ™ sequencing technology for the current SARS-CoV-2 pandemic and to help in containing future outbreaks.

Samuel Reed, President of DNAe commented: “We are dedicated to doing whatever we can to keep our employees and the public safe from this and future outbreaks, and that includes leveraging our technology which is uniquely suited for pandemic preparedness. We’ve always known that sequencing technology has this powerful ability to detect pathogens and accurately identify them, even particular strains. Now DNAe is developing a unique sequencing platform that is rapid, user-friendly and cartridge-based, running direct from sample – enabling it to be used in these urgent scenarios and a range of environments, where sequencing is badly needed but hasn’t been possible before.”

Internal testing to evaluate use of the LiDia-SEQ™ Platform to diagnose SARS-CoV-2 Infection

LiDia-SEQ™, DNAe’s rapid and easy-to-use diagnostic sequencing platform, was recently granted Breakthrough Device designation by the Food and Drug Administration in the USA. It is currently in development for infectious disease, including bloodstream infections/antimicrobial resistance with the support of BARDA*, as well as for oncology and other applications.  Now, system components are being evaluated for SARS-CoV-2. Due to the versatility of the technology, this leverages much of the research and development (R&D) to date and the technology would have unique impact during a global public health emergency, such as the one we are currently facing with COVID-19.

The unique potential benefits are:

  • Providing a highly accurate test (sensitive and specific), by using next generation sequencing (NGS) to identify the pathogen
  • Provide rapid (~hours vs. current days) and cost-effective results allowing for quick triaging: potentially including: isolating infected people, clearing patients from isolation who turn out to have a different illness, and potentially allowing non-infected frontline workers to return to work
  • Fast turnaround time allowing for increased testing throughput
  • Closed cartridge format will ensure minimal operator interaction – simply insert sample
  • DNAe’s benchtop platform will be easily deployable to temporary hospitals and potentially other environments to support triage
  • Easy-to-use allowing new operators to be rapidly trained on how to perform the test
  • The approach of viral sequencing would have the unique advantage of being for dual use: testing for routine diseases while being prepared for new outbreaks. This means that the system could be in widespread deployment, while aiding to earlier detect and contain any emerging or newly concerning strains. Currently systems depend on rapidly developing, vetting, and deploying new tests on a case by case basis, leading to logistical challenges and, in some cases, performance challenges.

*This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600017C.

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Contact Details

DNAe

Samuel Reed, President, DNAe Group

Please contact me via Instinctif (see below)

Instinctif Partners (media relations)

Ashley Tapp / Katie Duffell

Tel: +44 (0) 7792 472 293

Email: DNAe@instinctif.com

About DNAewww.dnae.com

DNAe is commercializing its pioneering semiconductor sequencing technology for healthcare applications where rapid point-of-need diagnostics are of critical need. It is developing LiDia-SEQ™, a user-friendly, direct-from-specimen platform that performs genomic analysis on a microchip, to provide actionable information to clinicians.

DNAe’s initial focus is on infectious disease diagnostics, where speed and DNA-specific 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. This will provide clinicians with actionable information to help select the appropriate antibiotics to treat the disease. A pipeline of follow-on tests are in development for viruses and cancer testing and monitoring.

The Biomedical Advanced Research and Development Authority (BARDA), a division of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), awarded DNAe a contract worth up to $51.9 million, if all options are awarded, to develop its diagnostic platform, initially for antimicrobial-resistant infections.

A private company, with facilities in London, UK and Carlsbad, CA, USA, DNAe has strong financial backing from its investors, including major shareholder Genting Berhad, a Malaysian-based global investor with a growing portfolio of cutting-edge life sciences companies.