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Coronavirus Highlights Need for Rapid Testing of Pathogens -- SECFilings.com

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Seattle, Washington--(Newsfile Corp. - March 9, 2020) - SECFilings.com, a leading financial news and information portal offering free real time public company filing alerts, announces the publication of an article discussing how LexaGene Holdings Inc. (OTCQB: LXXGF) (TSXV: LXG) is focused on making testing for pathogens quicker and easier than ever before.

A California woman was identified, on February 26, 2020, as the first U.S. resident to contract the coronavirus (COVID-19) from an unknown source. All other cases to that point had been traced to international travel or close contact with an infected individual. That is concerning, but the timing of the patient's treatment, testing, and diagnosis is potentially even more concerning. She initially checked into a hospital on February 15, was transferred to a larger hospital on February 19, was tested by the U.S. Centers for Disease Control (CDC) on February 23, and was diagnosed from test results on February 26. During those 11 days, and potentially prior, the patient was communicable and possibly infecting other people.

In a press conference on Thursday, February 27, California Governor Gavin Newsom indicated the state had 200 coronavirus test kits at its disposal. With more test kits expected to arrive in the coming days, the state remains woefully under-supplied in spite of its current focus on expanding testing for the disease. "We are currently in deep partnership with the [Centers for Disease Control and Prevention] on one overriding protocol that drives our principal focus right now, and that's testing," Newsom said, calling expanded testing "our top priority, not just in the state of California but, I imagine, across the United States."

One company, Beverly, MA-based LexaGene Holdings Inc. (OTCQB: LXXGF) (TSX-V: LXG), has developed a genetic analyzer capable of detecting a wide variety of pathogens and returning results on-site within an hour or so. The company's technology is an open-access platform, meaning the LX Analyzer can easily adapt to analyzing new tests developed by other sources and quickly configured to detect novel (new) pathogens that emerge. In the case of coronavirus, the company announced on February 20 that it had successfully detected the coronavirus RNA using its analyzer. LexaGene adapted the CDC Coronavirus Diagnostic Panel, released on February 4 under an Emergency Use Authorization issued by the U.S. Food and Drug Administration (FDA).



(LX2 Genetic Analyzer)

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Many experts believe the COVID-19 outbreak will slow down during the summer months and resurface in the fall, similar to the pattern of the 1918 influenza pandemic that killed 20 - 50 million. The availability of technologies like LexaGene's Analyzer, which is anticipated to go on sale in Q3, will be ideally used by many to help avoid a similar fate.

LX Analyzer - Fast and Adaptable

LexaGene's LX Analyzer has been developed over the last several years as a compact, easy to use, fast, adaptable genetic analyzer capable of detecting multiple pathogens and returning results in about an hour. The LX Analyzer offers distinct advantages over existing systems.

Perhaps the most important differentiator is that the LX Analyzer is an open-access platform. Many other genetic testing systems are closed platforms, meaning they can only run tests that have been developed by the manufacturer. In the realm of viral pathogens, as demonstrated by the rapid rise of COVID-19, timeliness is of the essence. Scientists across the world dive headlong into the task of identifying, characterizing, and testing for new viral strains. There is no guarantee that any one company is going to master a new pathogen test quickly, or more quickly than any other team across the globe. As a result, an effective testing platform should be adaptable to newly developed assays on a very short timetable so that healthcare providers have a better chance to contain the outbreak in the early stages when only a few are infected. That is the LX Analyzer advantage, in a nutshell.

The LX Analyzer also returns results onsite in an hour. This is a distinct advantage over shipping samples to laboratories that take days to return results. The LX Analyzer is a fairly small machine that can fit on a countertop, making it practical for onsite analysis in medical clinics and other types of facilities like airports and cruise ships. The system is also technically easy to run, removing the need for highly skilled technicians to conduct the test. Users can just load a raw sample and press 'Go'.

LexaGene will provide single-use testing cartridges to process samples for a razorblade-like recurring revenue business model. These cartridges are used to purify the genetic material within each sample. LexaGene will also sell its own validated assays for high-value pathogen targets (e.g. coronavirus) in various market verticals from human and veterinary diagnostics to food safety testing. An added benefit of the open platform is that it allows customers with unique testing needs to run their own tests on the LX Analyzer (e.g. pharmaceutical, academic, and government laboratories). In such cases, LexaGene still generates revenue from every sample processed, as these customers are still required to purchase single-use testing cartridges to process each sample.

Skilled Product Team

Dr. Jack Regan is the CEO and Founder of LexaGene. He invented the LX Analyzer technology as an automated solution for pathogen detection in response to years of experience in the area that includes developing instruments at Lawrence Livermore National Lab (LLNL) for biothreat detection. In fact, LexaGene has secured an exclusive license from LLNL to market the microfluidic technology that comprises the foundation of the LX Analyzer platform. Predecessor instruments were funded and/or used by the National Institutes of Health, the U.S. Department of Homeland Security, and the DHS' Biowatch Program.

Prior to founding LexaGene, Dr. Regan managed a team of scientists at Bio-Rad Laboratories that developed genetic testing systems for detecting pathogens, cancer, and neurological disorders. Before that, he played a key role in developing and commercializing QuantaLife's digital polymerase chain reaction (PCR) testing system. QuantLife was acquired by Bio-Rad in 2011. He combines the innovative approach of a scientific inventor with the business acumen required to bring a product to market.

Greg Dale is LexaGene's VP of Product Development and Manufacturing. He has a long history of developing and manufacturing products, and is listed as an inventor on 28 issued U.S. patents on PCR and microfluidics devices. He has small company experience to pair with his large company background with Qiagen, where he headed the Next-Generation Sequencing Engineering team. His engineering and manufacturing background are crucial to the success of the LX Analyzer device as the team prepares for commercialization.

Deeper on the LexaGene bench, Dr. Nathan Walsh is the VP of Applications - Bioinformatics. Dr. Walsh has a deep background in navigating the intersection of biology and information systems, with a focus in genetic sequencing, cancer detection, and pathway identification. Dr. Manoj Nair is a Senior Staff Scientist with more than 7 years of experience leading teams in the development of molecular diagnostic and pathogen identification assays. He is a trained veterinarian who also has a background in food safety testing, which are target markets for LexaGene's commercialization phase.

President Daryl Rebeck brings over 15 years of capital markets experience to the team, having developed a network of contacts and years of experience raising capital as VP and Senior Investment Advisor with Canaccord Genuity.

The Upshot

LexaGene has developed a pathogen detection system with characteristics crucial to the successful and timely diagnosis of novel diseases. The LX Analyzer, planned to reach commercial stage in Q3 2020, also has applications that reach far beyond viral pathogen detection for emerging outbreaks. The company views the veterinary market as a near term target, with far fewer regulatory hurdles than the human medical market. Food safety is another large market opportunity for the company. We will explore these in more detail in future articles. For now, keep an eye on LexaGene as it advances the fast, adaptable LX Analyzer to commercialization over the coming months.

Please follow the link to read the full article: http://bit.ly/2PWkWJ0

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