Breakthroughs and Advancements in Pathogen Detection Offer Hope as Virus Cases Surge

NEW YORK, July 21, 2020 /PRNewswire/ -- Effective pandemic response relies first and foremost on fast and accurate testing to buy time and save lives while therapeutics and vaccines are developed. Coronavirus cases continued to surge in the US this month, showing no signs of slowing since lockdowns lifted. 3 million confirmed cases in the US, with scientific estimates of 10 times more. Citizens of all stripes have sounded a clarion call for collective action and common sense. There is desperate demand for rapid and reliable tests, buying time and subduing the beast, until effective therapeutics and novel vaccines are developed. As the public waits in line for hours to get tested and then days for results, glitches are commonplace with reagent shortages, false negatives, and laboratory backups. From tests to vaccines, there has been a scramble for solutions from the best minds on the planet. Setting a new standard in testing, LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF) (LXG Profile) has developed a unique pathogen detection instrument—a fully automated genetic analyzer used to rapidly identify multiple pathogens, bacteria, and viruses including COVID-19. LexaGene's breakthrough technology is highly accurate, designed to be used at sample collection sites, and can deliver test results on 27 pathogens and/or antimicrobial resistance factors at once in about an hour. LexaGene is already working with the FDA on its submission plan for Emergency Use Authorization (EUA) for COVID-19 testing. Similarly, Roche Holdings (OTCQX: RHHBY) is ramping up production of its antibody tests to meet the ever-growing demand. Medical technology company Hologic, Inc. (NASDAQ: HOLX), primarily focused on women's health, has shifted focus to battle COVID and has created tests that detect genetic material from SARS-CoV-2. Vaxart, Inc. (NASDAQ: VXRT) is working on a potential vaccine, while Gilead Sciences Inc. (NASDAQ: GILD) is focused on therapeutics to shorten recovery time for severely ill COVID-19 patients. From every angle, the entire planet is focused on beating this disease and finding a way back to some semblance of normalcy. 

Click here to view the custom infographic of the LexaGene Holdings Inc. (TSXV: LXG) (OTCQB: LXXGF) editorial.

Test, Test, Test

Testing is the first and foremost tool in the fight against the coronavirus. But with cases in the US and around the world skyrocketing, the need for faster, more accurate tests is urgent. Public health experts across the globe agree that early detection is paramount to controlling the spread of the disease. Fast, accurate testing allows for contact tracing and isolating infections to stop rampant spread, but the country is falling short on testing as demand for tests far outstrips supply and availability. Sad and dramatic evidence of urgency could be found in Phoenix recently – people witnessed an 8-hour wait for testing followed by 10 business days to get results as hospital ICU beds reached capacity. There's little evidence that the near future will prove any better without improved testing.

A New Paradigm in Testing

Massachusetts-based LexaGene (TSXV: LXG) (OTCQB: LXXGF) (LXG Profile) is establishing a new paradigm in pathogen detection. From inception, LexaGene has focused on developing a fully automated genetic analyzer that rapidly screens for multiple pathogens at once—namely COVID-19, influenza, RSV, adenovirus, metapneumovirus, and seasonal coronavirus, and performs gold-standard chemistry for exceptional data quality. LexaGene's unique open-access pathogen detection instrument is designed to quickly detect multiple pathogens simultaneously with sensitivity and specificity; to be compact, portable, and easily used at sample collection sites; and to efficiently return results in about one hour.

Using microfluidic technology, LexaGene's flagship MiQLab(TM) analyzer (previously named LX Analyzer) can screen samples for up to 27 different pathogens and/or antimicrobial resistance factors at once and produces results in about one hour. The MiQLab analyzer offers a set of features not currently available in the market today. The technology's open-access feature allows researchers in biotech, pharma, and academic laboratories to customize their testing, whether it is to detect rare infectious diseases, screen for cancer, or perform mRNA expression profiling. Researchers and scientists who currently spend hours manually performing polymerase chain reaction (PCR) because they have custom testing needs, are now able to run those same tests in a fully automated fashion. What's more, LexaGene's technology can be configured to process large volume samples, for extreme sensitivity. The open-access feature makes the system uniquely poised to become a critical part of preventing the spread of emerging strains of new infectious diseases to help avert future pandemics like COVID-19.

Efficacy Imperative

Perhaps nowhere is efficacy so urgent as in the current quest against coronavirus. In a testament to efficacy, LexaGene recently placed a pre-commercial instrument for COVID-19 testing in a major US hospital laboratory. Just over a month ago LexaGene announced it had placed an instrument that tests for COVID-19 and other respiratory pathogens at the Dartmouth-Hitchcock Medical Center's Laboratory for Clinical Genomics and Advanced Technology (CGAT) in Hanover, New Hampshire.

"Our standard test for SARS-CoV-2, the pathogen that causes COVID-19, takes about 7.5 hours. Given the highly contagious nature of this virus, this is a long time to wait," stated professor and Vice Chair for Research Director at CGAT Dr. Gregory Tsongalis, PhD, HCLD, CC. "We want the ability to get results much faster and to be able to screen for more pathogens at once since respiratory symptoms can be caused by numerous other viruses."

"We are excited to be able to contribute to the fight against COVID-19 and illustrate our applications in the human clinical space," commented LexaGene founder and CEO Dr. Jack Regan. "Unlike many of the near-patient testing solutions used today that only look for COVID-19 and have a significant false negative rate, the instrument we have placed at Dartmouth-Hitchcock screens for many pathogens at once, namely COVID-19, influenza, RSV, adenovirus, metapneumovirus, and seasonal coronavirus, and it performs gold-standard chemistry for exceptional data quality. Our breadth of detection allows users of our technology to generate informative data for the vast majority of people with respiratory symptoms. This is particularly important as healthcare providers are increasingly questioning negative results from COVID-19 only tests, wondering if the test result is a false negative or the person is sick from another pathogen."

LexaGene recently provided an update on COVID-19 testing at CGAT. "From the samples tested to date, we have detected numerous positive COVID-19 samples as well as negative samples which are equally important," Regan added. "In contrast to many technologies that only provide a 'yes' or 'no' answer as to whether the virus was detected, LexaGene's technology provides quantitative data on how much virus is detected."

"By quantifying the amount of virus present, we can help clinicians determine if a patient is possibly early in the infection cycle, late in the infection cycle, or if their immune system successfully contained the growth of the virus. In the hospital study, we have detected COVID-19 positive samples that are more than 25,000-fold different in the amount of detected virus. Quickly identifying individuals with such high viral loads is especially important for disease containment," he concluded.

Announced in the same release, LexaGene has received comments back from the FDA on its submitted plan for Emergency Use Authorization (EUA) for COVID-19 testing. Since submitting the application, the FDA updated its template for manufacturers, changing some requirements. LexaGene has amended its plan and is now waiting for further communication from the FDA, which it anticipates soon. Per industry standards, until proposed studies are completed, and the FDA grants LexaGene's instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as "Research Use Only." 

Savvy investors can easily intuit what will happen to LexaGene if EUA approval is granted. Given the efficacy, accuracy, ease of use, and critical global demand – it's hard to imagine that LexaGene's breakthrough testing technology won't gain approval in the midst of this unprecedented crisis.

In the Fight

Fear is the only thing spreading faster than this disease, and the entire planet is focused on combating it. 

Roche Holdings (OTCQX: RHHBY) is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology, and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, a frontrunner in diabetes management and is ramping up production of its antibody tests to meet ever-growing demand.

Hologic, Inc. (NASDAQ: HOLX) is an innovative medical technology company focused on improving women's health through early detection and treatment. Like many others, the company shifted focus to battle COVID and has created tests that detect genetic material from SARS-CoV-2. Hologic recently received Emergency Use Authorization from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

Vaxart, Inc. (NASDAQ: VXRT) is a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection. The company just announced that its oral COVID-19 vaccine has been selected to participate in a non-human primate challenge study, organized and funded by Operation Warp Speed.

Gilead Sciences Inc (NASDAQ: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead is working closely with global health authorities to respond to the novel coronavirus outbreak through the appropriate use of the therapeutic drug remdesivir.

For further information on LexaGene (TSXV: LXG) (OTCQB: LXXGF) please visit LexaGene.

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