LexaGene's LX Analyzer Successfully Detects Coronavirus RNA using the CDC's Tests

BEVERLY, Mass., Feb. 20, 2020 (GLOBE NEWSWIRE) -- LexaGene Holdings Inc. LXXGFLXG ("LexaGene" or the "Company"), a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers, announced today the successful adaptation of the Centers for Disease Control and Prevention (CDC) Coronavirus Diagnostic Panel¹ to their LX technology platform.

The COVID-19 outbreak (formally called 2019-nCoV) is the most lethal coronavirus outbreak so far, surpassing the 2002 SARS² and 2012 MERS³ outbreaks. As of February 19, 2020, more than 75,000 cases and 2,000 deaths were reported worldwide.⁴ This illness has been reported in 25 countries and been declared by the World Health Organization as a "public health emergency of international concern."⁵

Dr. Jack Regan, LexaGene's CEO and Founder, states, "The world needs easy-to-use fully automated pathogen detection instruments operating at points-of-need that can be equipped with tests to detect a novel pathogen within a week of knowing its genetic sequence. For this outbreak – the lack of such technology forced all testing to occur in distant reference laboratories, making rapid decisions on quarantine impossible and making the likelihood of successful containment remote. This shortcoming has arguably cost hundreds of lives to date. LexaGene expects to be the first company to commercialize an automated open-access microfluidic technology designed for use at the point-of-need that can be configured to detect a novel pathogen in just a week's time of its emergence – for use on-site to return results in one hour – and improve our chances of successful containment."

One of the hallmarks of LexaGene's LX Analyzer technology is its open-access feature that allows users to very quickly introduce newly developed assays into the platform for fully automated and rapid detection of novel pathogens. To demonstrate this, LexaGene's scientists adapted the CDC Coronavirus Diagnostic Panel to the LX Analyzer platform. The CDC panel is comprised of three tests for SARS-CoV-2, the pathogen that causes COVID-19. This CDC panel has been granted Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA).⁶

Using LexaGene's automated LX Analyzer equipped with the adapted CDC Coronavirus Diagnostic Panel, the Company successfully detected the presence of the SARS-CoV-2 N-gene RNA in contrived respiratory samples, whereas the severe acute respiratory syndrome (SARS) coronavirus RNA and Middle East respiratory syndrome (MERS) coronavirus RNA tested negative, as expected. In addition, the virions of the unrelated seasonal common cold virus, the human coronavirus OC43 (ZeptoMetrix⁷) was successfully detected by a specific assay, but tested negative with the CDC Panel, as expected.

Dr. Jack Regan continued, "I've spent my career working on improving infectious disease diagnostics. LexaGene's rapid pathogen detection instrument is needed in our fight against the COVID-19 epidemic. Our successful adaptation of the COVID-19 Diagnostic Panel onto the LX platform, not only demonstrates the platform's open-access capability, but also signifies our expansion into including respiratory pathogens as part of our menu as we prepare for commercial launch later this year."

In addition, on February 19, the board of directors and compensation committee approved inducement grants in accordance with the Company's Omnibus Incentive Plan for insiders totaling 1,285,000 restricted share units ("RSUs") and 320,000 Options. Each Option is exercisable into one common share of the Company ("Share") at a price of $0.72 per Share, for a period of ten years from the date of grant. The RSUs and options will vest 25% starting on 02/19/2022 and then 25% every four months thereafter. The RSUs will have an expiry date of 02/19/2023. 

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¹ https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-panel-primer-probes.html
² https://www.who.int/csr/sars/country/table2004_04_21/en/
³ https://www.who.int/emergencies/mers-cov/en/
⁴ https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200219-sitrep-30-covid-19.pdf?sfvrsn=6e50645_2
⁵ https://www.bbc.com/news/world-51318246
⁶ https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov
⁷ https://www.zeptometrix.com/products/coronavirus-strain-oc43-culture-fluid-1-ml

About LexaGene Holdings Inc.
LexaGene is a biotechnology company that develops genetic analyzers for pathogen detection and other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go'. The LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can return results in about 1 hour. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.

Media Contacts
Nicole Ridgedale
Director of Corporate Marketing, LexaGene
800.215.1824 ext 206
nridgedale@lexagene.com

Investor Relations
Jay Adelaar
Vice President of Capital Markets, LexaGene
800.215.1824 ext 207
jadelaar@lexagene.com

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This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors -- including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues -- that could cause actual results to differ materially from the Company's expectations as disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.