viewLexaGene Holdings Inc.

LexaGene advances its pathogen-detection technology in battle against coronavirus


The company has configured its MiQLab system to investigate novel variants of SARS-CoV-2 and is pursuing US Food & Drug Administration (FDA) emergency use authorization (EUA)


Quick facts: LexaGene Holdings Inc.

Price: 1.12 CAD

Market: TSX-V
Market Cap: $128.08 m
  • Transforming traditional pathogen detection through its patented platform
  • Targeting vast and underserved multi-billion-dollar markets
  • Automated MiQLab system can test for 27 pathogens including coronavirus with results in an hour

What LexaGene does:

LexaGene Holdings Inc (CVE:LXG) (OTCMKTS:LXXGF) is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety as well as for use in open-access markets such as clinical research, agricultural testing, and biodefense. 

The Beverly, Massachusetts-based company says 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 MiQLab system delivers excellent sensitivity, specificity, and breadth of detection, can test for 27 pathogens and return results in about one hour versus 1-3 days at a lab. 

The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR (polymerase chain reaction) assays onto the instrument to target any genetic target of interest. The system’s predecessor was LX2 Genetic Analyzer.

Moreover, the technology is suited for rapid pathogen detection and can be used across a variety of markets, including the detection of the 2019-novel coronavirus (COVID-19) and its variants.

The company has claimed that unskilled workers can be trained in as little as one hour to operate the MiQLab, and that there is no complex work involved like pipetting of fluids. And the test can be performed anywhere - from stadiums to airports and from cruise ships to schools.

CEO Jack Regan developed LexaGene’s patented microfluidic system. He was also a lead scientist in developing another instrument designed for bio-warfare surveillance used by the US Department of Homeland Security, and a device for detecting respiratory pathogens from nasal swab samples.

How is it doing:

LexaGene launched into 2021 by initiating a program that uses the rapid configurability of its MiQLab system to investigate novel variants of SARS-CoV-2, the pathogen that causes the COVID-19 disease.

The company noted that SARS-CoV-2 mutates quickly and new variants were recently identified in the UK (B.1.1.7) and South Africa (B.1.351). Both new strains appear to be about 70% more contagious, making containment that much more challenging.

LexaGene maintains that it is critical that medical authorities have the capability to not only detect whether a patient is COVID-19 positive, but also whether he or she is infected with a new variant. 

As a result, the company is now pursuing emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for COVID-19 testing using LexaGene assays that are predicted to detect 99.9% of the strains circulating today based on published sequences, including the UK and South African variants.

And given the suspected higher rate of transmissibility of these variants, it is crucial that researchers distinguish these new variants from the original strain. MiQLab can as easily be configured to run tests for both coronavirus detection and strain identification as it is capable of screening for up to 27 genetic targets at once.

To date, there is no FDA-approved device that is designed for point-of-care (POC) usage and is open-access. But LexaGene has designed and ordered components for tests to distinguish the UK and South African strains from the traditional coronavirus strain and will confirm this work on the MiQLab system.

Meanwhile, LexaGene has no plans to incorporate these new tests into a series of studies - required by the FDA for an emergency use authorization (EUA) for its COVID-19 tests - that began late last month. Under that separate FDA track, the tests will look at the company’s COVID-19 assay in a POC environment using its automated MiQLab system. 

The majority of tests authorized by the FDA for COVID-19 testing are reagent-only chemistry tests that can only be used by trained professionals in the 17,432 high complexity reference US labs. However, results can take days.  

To speed up time-to-result, the FDA has prioritized submissions for POC testing solutions like MiQLab where results can be generated on-site. But since the system is automated, more rigorous FDA studies are mandated.  

LexaGene anticipates submitting its MiQLab system to the FDA for POC-use status. The company notes that there are 193,4744 US locations certified to run POC tests, making for a much larger market opportunity than the high-complexity laboratories alone.

As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using its instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.

Inflection points:

  • Expects FDA EUA to test for novel coronavirus variants circulating today based on published sequences
  • Anticipates submitting FDA EUA application for POC-use status for its MiQLab system
  • Build sales funnel by expanding to veterinarian, food, and open-access markets

What the boss says:

As the world grapples with the coronavirus outbreak, LexaGene’s MiQLab system could emerge as a major instrument in facilitating quick diagnoses, the company's CEO Jack Regan recently said.

“We founded LexaGene to fill a critical technology gap in our defenses against new pathogens. LexaGene’s MiQLab is designed to be a point-of-care system that is open-access in nature," he said.

"Once a pathogen emerges or mutates, the MiQLab system is designed to quickly onboard new tests to detect a desired target, which would speed up timelines for point-of-care testing. Detecting these variants quickly inside hospitals, clinics, and other testing locations maximizes the chances of successfully containing these new threats."

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

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