LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF)

LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF) is a molecular diagnostics company that develops genetic analyzers for rapid detection of pathogens at the point-of-need.

Based in the greater-Boston, Massachusetts area, the company's fully automated genetic analyzer for pathogen detection, the MiQLab™, is designed to deliver reference-quality data with ease of use. MiQLab's technology screens samples for up to 27 different targets at once—looking for pathogens and antimicrobial resistance factors—and returns results in approximately one hour. It is designed to be operated at the site of sample collection to avoid the delay associated with shipping and manually processing samples. This technology is designed for use in multiple markets, including human and veterinary diagnostics, as well as food safety testing ($12.9B, $2.2B, and $23.4B markets, respectively).

Portfolio Benefits

Rapid, automated pathogen detection

LexaGene's MiQLab pathogen detection system offers rapid and sensitive testing to markets in need of better vigilance against pathogens that could endanger health and harm public safety and the bottom line. The company's disruptive technology is on-demand and offers results in approximately an hour.

End users collect a sample, load it onto the MiQLab genetic analyzer with a sample preparation cartridge, enter a sample ID and press 'go'.

MiQLab is open-access, which allows users to easily customize their own tests, in addition to running the company's own validated tests. No comparable technology exists on the market today for automating customized testing. The open-access market is over $20 billion in value and includes industries like pharma and biotech that currently need an automated method of performing PCR testing in a cost-efficient way.

Improved COVID-19 Testing

As the COVID-19 pandemic continues to pose a threat to global safety, the need for improved testing procedures has been well established. LexaGene's technology is automated and designed to be used at the point-of-need, thereby avoiding the 12- to 24-hour shipping time. Plus, it performs sample preparation and the gold standard RT-PCR chemistry for exceptional data quality in about one hour.

Because LexaGene's open-access instrument can be rapidly configured to detect novel pathogens, it is ideally suited to prevent pandemic spread with its easily deployed testing that facilitates rapid quarantine-related decision making.

This speed is in stark contrast to competitor point-of-care technologies that have reagents pre-embedded into complex and expensive cartridges that are only manufactured at specialized production sites – making it impossible to rapidly meet a swift increase in demand.

According to Dr. Jack Regan, LexaGene's CEO and founder, 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 pandemic, the lack of such technology forced the majority of testing to occur in distant reference laboratories, making rapid decisions on quarantine impossible and making the likelihood of successful containment remote.

Regan explained in a press release (http://nnw.fm/Vz5Ju), "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."

Market Potential

LexaGene's technology has a wide range of applications across many other markets, including biotech and pharma testing, water quality monitoring, agricultural testing, biodefense, and use at point-of-need at border crossings, military bases, aircraft carriers and cruise ships.

Markets for customized testing solutions are poised for significant growth. Industry analysts forecast considerable expansion of many of LexaGene's potential target markets in the coming years, including:

• The genotyping sector, forecast to reach a valuation of $31.9 billion by 2023;
• PCR assays, expected to make up a $7 billion market opportunity by 2026;
• The sample prep market, forecast to eclipse $9.3 billion by 2025;
• Water quality monitoring, set to grow to $1.59 billion by 2022; and
• Agricultural testing, anticipated to reach $6.29 billion by 2022.

LexaGene's patented microfluidic system was invented by company CEO Regan, a leading scientist who developed a bio-warfare surveillance instrument that has been adopted by the Department of Homeland Security. Regan is also known for developing an instrument that detects respiratory pathogens from nasal swab samples. The development of these instruments was supported by $20 million in government funding.

Management Team

LexaGene's experienced leadership team drives company growth with a focus on innovation, pursuing unique market opportunities and providing shareholder value.

Dr. Jack Regan, Chief Executive Officer & Director, is the inventor of the company's flagship automated pathogen detection technology, the MiQLab. Before founding LexaGene, he led a team of scientists at Bio-Rad Laboratories (NYSE: BIO) in developing tests for detecting pathogens, cancer and neurological disorders using droplet digital PCR. Prior to Bio-Rad, Regan helped QuantaLife, a startup company, bring its product from concept to commercialization, where it was subsequently acquired by Bio-Rad. He has also worked at Applied Biosystems/Life Technologies on automated sample preparation and did his post-doctoral training at Lawrence Livermore National Laboratory. His doctoral training at the University of California San Francisco focused on influenza viral replication.

Daryl Rebeck, President, has over 20 years of capital market experience with an established international financial network. Rebeck was a vice president and senior investment advisor with Canada's largest independent investment bank, Canaccord Genuity, where he was responsible for raising significant risk capital for growth companies, with a particular focus on natural resources and medical technology. He has since worked to provide management expertise and grow shareholder value. He served as senior VP of corporate finance of Auryn Resources (NYSE: AUG), a $250 million market cap mining exploration company.

Jeffrey Mitchell, CFO, boasts over two decades of financial and SEC experience. Before joining LexaGene, he served as controller and director of finance, overseeing areas such as public company financial reporting, audits, and financial planning and analysis for Palomar Medical Technologies Inc. In addition to his many years at Palomar, Mitchell has served in numerous financial and strategic advisory roles for medical device, imaging and diagnostic companies.