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

NetworkNewsWire Editorial Coverage

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.

About NetworkNewsWire 

NetworkNewsWire ("NNW") is a financial news and content distribution company, one of 40+ brands within the InvestorBrandNetwork ("IBN"), that provides: (1) access to a network of wire solutions via NetworkWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) social media distribution via IBN millions of social media followers; and (5) a full array of corporate communications solutions. As a multifaceted organization with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience comprising investors, consumers, journalists and the general public. By cutting through the overload of information in today's market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.  

To receive SMS text alerts from NetworkNewsWire, text "STOCKS" to 77948 (U.S. Mobile Phones Only) 

For more information, please visit: https://www.NetworkNewsWire.com 

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer 

NetworkNewsWire is part of the InvestorBrandNetwork 

DISCLAIMER: NetworkNewsWire (NNW) is the source of the Article and content set forth above. References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. FN Media Group (FNM) is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated with NNW or any company mentioned herein. The commentary, views and opinions expressed in this release by NNW are solely those of NNW and are not shared by and do not reflect in any manner the views or opinions of FNM. Readers of this Article and content agree that they cannot and will not seek to hold liable NNW and FNM for any investment decisions by their readers or subscribers. NNW and FNM and their respective affiliated companies are a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security. 

The Article and content related to the profiled company represent the personal and subjective views of the Author, and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author has not independently verified or otherwise investigated all such information. None of the Author, NNW, FNM, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer's filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer's securities, including, but not limited to, the complete loss of your investment. 

NNW & FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE. 

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements.  The forward-looking statements in this release are made as of the date hereof and NNW and FNM undertake no obligation to update such statements. 

Corporate Communications Contact: 

NetworkNewsWire (NNW) 
New York, New York 
www.NetworkNewsWire.com  
212.418.1217 Office 
Editor@NetworkNewsWire.com  

Media Contact: 

FN Media Group, LLC 
NNW@FinancialNewsMedia.com  
+1-(954)345-0611