13 May 2020 - - UK- and US-based sequencing company DNAe, which is developing novel diagnostics for use at the point-of-need, is reporting positive results from internal tests using its LiDia-SEQ sequencing technology to identify SARS-CoV-2.

The SARS-CoV-2 coronavirus is the cause of the COVID-19 pandemic currently causing extensive mortality, morbidity and disruption globally.

DNAe's LiDia-SEQ prototypes have been used to analyze synthesized samples (nucleic acids) representing SARS-CoV-2, including both automated preparation and sequencing of the samples.

Fragments were successfully amplified in disposable cartridges, in a self-contained and fully automated process. Samples were also sequenced and identified as matching SARS-CoV-2.

The ability to sequence samples in a rapid and self-contained format will be unprecedented.

And by utilising sequencing data, LiDia-SEQ will be able to provide more accurate and detailed information on the virus than conventional tests, including determining the strain.

LiDia-SEQ, the world's first rapid and direct-from-specimen diagnostic sequencing platform, is in development for multiple applications including diagnostics for infectious diseases and cancer, with the support of major investor Genting Berhad and BARDA.

BARDA has awarded DNAe a contract worth up to USD 51.9m if all options are awarded, to support development of the system, initially for antimicrobial-resistant infections, and this platform and assay were recently granted Breakthrough Device designation by the USA Food and Drug Administration.

DNAe is commercialising its semiconductor sequencing technology for healthcare applications where rapid point-of-need diagnostics are of critical need, including infectious disease and cancer testing and monitoring.

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 and antimicrobial resistance, 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 is 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 in the US Department of Health and Human Services, awarded DNAe a contract worth up to USD 51.9m, 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's major shareholder is Genting Berhad, a Malaysian-based global investor with a growing portfolio of investments in cutting-edge life sciences companies.