LexaGene CEO Discusses COVID-19 Testing, Commercialization Strategy -- SECFilings.com

4/16, 3:00 PM (Source: Newsfile Corp)

Redondo Beach, California--(Newsfile Corp. - April 16, 2020) - SECFilings.com, a leading financial news and information portal offering free real time public company filing alerts, announces the publication of an interview with Dr. Jack Regan, CEO and Founder of LexaGene Holdings Inc. (OTCQB: LXXGF) (TSX-V: LXG), discussing the company's development of genetic analyzers capable of quickly and accurately detecting pathogens, including COVID-19.

Dr. Regan has an extensive background in virology, and particularly respiratory pathogens and bio-threat agents. In the interview, Dr. Regan covers the unique capabilities of the LexaGene Genetic Analyzer, and the company's evolving commercialization strategy in light of the current pandemic and the FDA's Emergency Use Authorization program to get COVID-19 related products into the marketplace more quickly.

Q. Let's get right to the most topical point. LexaGene's LX Analyzer is capable of detecting coronavirus RNA and returning results in one hour. Can you talk a bit about your LX Analyzer's capabilities as compared to some of the testing and detection solutions that are currently available?

A. The limitations of current testing that we've been seeing for COVID-19 can be boiled down to three different factors: accuracy, time-to-result, and breadth of detection, all of which LexaGene has solved. Here is some more detail on these three critical factors.

Simply put, accuracy is a measure of how often your test returns the correct answer. The type of chemistry used in detecting pathogens affects accuracy. To achieve high accuracy - certified clinical testing reference laboratories have highly skilled technicians perform a gold standard chemistry called PCR. Another type of chemistry, called isothermal amplification is sometimes used, but multiple peer reviewed journal articles have shown that it does not have the same level of accuracy as PCR tests. As such, it is important to evaluate how harmful a false result is for the ability to contain a new virus from spreading to others.

For diagnostics, the shorter the time-to-result the better for rapid decision-making. Standard time-to-result is >24 hours, as the vast majority of tests are performed using PCR in reference laboratories, where samples can spend hours in transit and manual steps in the lab. By automating the chemistry so that testing can occur at the point-of-need, it is possible to drastically improve the time-to-result. At first glance, super-fast point-of-care tests (e.g. < 20 min) performed inside the hospital by healthcare workers seem fantastic, but these tests (isothermal and antibody-based) are much more likely to return a false negative result due to inferior chemistry, which can have dire consequences. PCR, by contrast is highly accurate.

As far as breadth of detection is concerned, the more pathogens a test screens for - the more likely it is to return a result that is valuable to the healthcare provider. For COVID-19 testing, the vast majority of tests performed today are singleplex tests - which means they only test for COVID-19, which leaves physicians in the dark when the test comes back negative (which happens most of the time).

LexaGene has solved these three problems. It brings together all of the features that are the most important for infectious disease testing. Namely, gold-standard accuracy, fast time-to-result, and screening for multiple pathogens at once. LexaGene's commercial product is designed to be used inside hospitals and other point-of-need places, where it will return exceptionally accurate results in about 1-hour (or less) and each test screens for up to 27 pathogens at once, thereby generating usable data for healthcare providers.

LexaGene's value is that it brings reference lab-quality test results to the point-of-need, where the technology is designed to be run by non-technical workers. Another benefit is that LexaGene's technology is 'open-access' which means tests can be customized to detect any genetic target of interest. This has great appeal for many markets outside of human clinical diagnostics (e.g. pharmaceutical companies, academic laboratories, government laboratories, border crossing applications, water quality testing, aquaculture pathogen surveillance, etc.). It is also extremely valuable for detecting a novel pathogen just days after its sequence has been determined. This makes LexaGene's technology an ideal solution for pandemic prevention.

Q. You mention multiplex testing. What are the advantages of multiplex testing over single tests like the ones we are seeing for COVID-19?

A. We are developing a multi-virus diagnostic panel that will screen for many pathogens, including SARS-CoV-2, the pathogen that causes COVID-19. Doctors using this panel are much more likely to return a positive answer than if they use a single-plex test that only looks for one pathogen. When healthcare professionals get a negative result on a COVID-19-only test, they are left wondering whether it is a false-negative result or the patient is sick with another pathogen (e.g. influenza) for which a specific therapy could be prescribed. LexaGene has developed specific tests in its test panel for the major pathogens that cause respiratory illness including SARS-CoV-2, influenza A & B, RSV, human metapneumovirus, etc. LexaGene's technology is extremely easy to use. After a sample is collected from the patient, the healthcare provider would load the sample into a sample preparation cartridge that is inserted into the instrument, enter patient sample ID, then press 'go' and walk away. No micro-pipetting or other steps are required. Upon run initiation, LexaGene's Genetic Analyzer purifies the genetic material in the sample and splits it into distinct tests looking for many different pathogens and returns results in about one hour.

Q. How has the pandemic changed LexaGene's commercialization plan? Originally slated for Q3 2020 introduction to the veterinary markets, there is now talk of utilizing the FDA's Emergency Use Authorization to explore commercialization for human pathogen testing on a priority timeline compared to your earlier plans for the human medical market. What can you tell us about this?

A. Originally, we planned on entering the human clinical in-vitro diagnostics (IVD) market after success in markets where the regulatory hurdles are lower (e.g. veterinary diagnostics and food safety). The COVID-19 pandemic has provided LexaGene a fantastic opportunity to enter the human IVD market much earlier than anticipated, since the FDA has requested vendors to submit for Emergency Use Authorization for COVID-19 testing. This will very likely allow LexaGene to start selling into this market as soon as the company starts selling instruments. Having entered this market, it will be easier for the company to then pursue FDA 501K clearance, which is the typical regulatory path in the absence of a declared public health emergency. In short, we haven't pivoted our strategy entirely; we've simply expanded our strategy to include human diagnostics and COVID-19 testing in an advanced timeline.

Q. You are a virologist with a deep background in pathogen detection, even specializing in respiratory pathogens at one point. Seems like a perfect match with the issues surrounding the COVID-19 pandemic. Can you give us an overview of how your experience led to the development of the LX Analyzer? More specifically, how has your background prepared you to lead the company as it responds to address the detection of COVID-19?

A. I did my doctoral training focused on influenza viral replication. In my career, I've developed automated instruments to detect respiratory pathogens and bio-threat agents for the US government's Department of Homeland Security BioWatch program. I've also previously worked at QuantaLife, a startup company, where I helped the team commercialize ddPCR technology and get acquired by Bio-Rad Laboratories for $162M. I then founded LexaGene with my partner Daryl Rebeck to help bring open-access pathogen detection to markets in need of true diagnostic innovation.

LexaGene has long been talking about the dangers of emerging infectious disease and pandemics. The current COVID-19 pandemic has brought the world's attention to the importance of containing a novel pathogen quickly and has highlighted a need in the diagnostic space for the kind of technology LexaGene is building. We are working hard to address this current crisis. Unfortunately, COVID-19 is likely going to become a seasonal pathogen - and LexaGene will be selling instruments this fall to help healthcare providers more accurately detect this pathogen and do the necessary contact tracing that will be required to curb its spread. The availability of LexaGene's technology in the fall will mean the world will be better equipped to better contain the next novel pathogen.

Q. With the current emergency dictating some of your strategy, it's important to not lose sight of LexaGene's bigger picture plans and addressable markets. Prior to coronavirus, the most immediate areas of focus were on the veterinary and food safety markets. What is the potential for the LX Analyzer in those industry sectors?

A. The market opportunity and demand in these industries remain high and we will continue to focus our strategy on penetrating veterinary diagnostics and food safety testing. The competition and regulatory barriers are lower in these industries and we have significant advantages - namely ease of use and cost competitiveness - that make us attractive to these markets.

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