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Second Wave Concerns Create Urgent Need For Fast, Accurate Tests and Plausible Vaccines


News provided by

Microsmallcap.com

29 May, 2020, 12:45 GMT

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- FN Media Group Presents Microsmallcap.com Market Commentary

NEW YORK, May 29, 2020 /PRNewswire/ -- As countries around the globe begin to lift stay-at-home orders and return to work, the World Health Organization (WHO) is warning that lifting public health restrictions too early could result in an "immediate second peak". Testing is being viewed as the key to containing the spread of the pandemic and re-opening the economy until a safe vaccine is developed. At the same time, getting the world back to where it was pre-virus will require either herd immunity or a widely available vaccine. The potential second wave of COVID-19 has spurred an increased interest in biotechnology companies like Co-Diagnostics, Inc. (NASDAQ:CODX), and LexaGene Holdings, Inc. (TSX-V:LXG) (OTCQB:LXXGF), who are creating rapid, accurate tests. The urgency, however, is causing concern over thepotential inaccuracy of current tests on the market, particularly the one created by Abbott Labs (NYSE:ABT). On the vaccine front, companies like Moderna (NASDAQ:MRNA) and Sorrento Therapeutics, Inc. (NASDAQ:SRNE) are continuing to move through the necessary phases to bring a vaccine to market as soon as safely possible.

Although the renewed sense of panic comes from the potential of a second virus wave, a top health expert warns that we haven't even made it through the first yet. "Right now, we're not in the second wave. We're right in the middle of the first wave globally," said Dr. Mike Ryan, the executive director at WHO. "We're still very much in a phase where the disease is actually on the way up."

Regardless if we are still in the midst of the first wave or headed into the second, officials have made it clear that mass testing is essential to keeping the virus under control.

Fast, Accurate Testing Needed to Safely Reopen

At the beginning of the pandemic, many countries lagged behind in their testing efforts due to a lack of resources. There just simply weren't enough tests available to meet their needs. What's more, the tests available took days to show results, creating a barrier within itself.

Luckily, biotech company LexaGene Holdings, Inc. (LXG.V) (LXXGF.QB) has developed a genetic analyzer that is capable of quickly and accurately detecting a number of pathogens, including the presence of the SARS-CoV-2 N-gene RNA in contrived respiratory samples. Unlike most of the testing solutions being used today, which only look for signs of the current virus and have a significant false-negative rate, LexeGene's analyzer screens for multiple pathogens at once, including COVID-19, influenza, RSV, adenovirus, metapneumovirus, and seasonal coronavirus.

LexaGene Holdings, Inc.  genetic analyzer allows users to generate data for the vast majority of people with respiratory symptoms, which is particularly important at a time when healthcare providers are increasingly questioning negative results from coronavirus-specific tests, wondering if the test result is a false negative or the person is sick from another pathogen.

On May 28, LexaGene Holdings, Inc. (LXG.V) (LXXGF.QB) announced the placing of its pre-commercial instrument at the Dartmouth-Hitchcock Medical Center (DHMC) into their Laboratory for Clinical Genomics and Advanced Technology (CGAT) of the Dartmouth-Hitchcock Medical Center (DHMC), in New Hampshire.

According to DHMC, the addition of LexaGene's LX Analyzer will allow the facility to obtain test results much faster and provide them with the ability to screen for more pathogens at once since respiratory symptoms can be caused by numerous other viruses.

Molecular diagnostics company Co-Diagnostics, Inc. (NASDAQ:CODX) has also developed an in vitro diagnostic COVID-19 test kit. The company was granted FDA Emergency Use Authorization and has manufactured more than six million tests to date.

Meanwhile, Abbott Labs (NYSE:ABT) has shipped more than 2 million ID NOW rapid molecular tests across the country since gaining FDA Emergency Use Authorization in March. Demand for the test has continued to surge after new data from an urgent care clinic study reveals the ID NOW test performance of ≥94.7% positive agreement (sensitivity) and ≥98.6% negative agreement (specificity).  The Everett Clinic study showed a 91.3% positive agreement and 100% negative agreement.

Vaccines Inch Closer to Becoming a Reality, But Could Still Be Far Off

World leaders in several countries have pledged billions for research into a vaccine against the new virus and said that life won't return to "fully normal" until there is a vaccine. According to those same officials, that could take 12-18 months, but some medical experts consider that timeline to be "ridiculously optimistic." In fact, the typical vaccine takes between eight and 10 years to develop.

Luckily, the FDA is helping some companies fast track the process to make the 18-month timeline more feasible. The FDA's fast track is a "process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need."

On May 12, Moderna's (NASDAQ:MRNA) mRNA vaccine candidate (mRNA-1273) was granted Fast Track designation from the FDA and given the green light to proceed to a Phase 2 study.

Moderna expects to begin Phase 2 shortly and is already finalizing the protocol for a Phase 3 study, which is expected to begin in early summer 2020.

Meanwhile, clinical-stage biopharmaceutical company Sorrento Therapeutics, Inc. (NASDAQ:SRNE) is also making headway with its anti-SARS-CoV-2 antibody, STI-1499.

On May 15, the company announced that STI-1499 demonstrated 100% inhibition of the virus infection in an in vitro virus infection experiment at a very low antibody concentration, revealing "exceptional therapeutic potential that could potentially save lives following receipt of necessary regulatory approvals."

Whether a vaccine or treatment will come to market in the next year and a half remains to be seen, however, it's encouraging to see Moderna's (MRNA) and Sorrento Therapeutics, Inc. (SRNE) advancing their efforts. In the meantime, governments will continue to seek out rapid tests from companies like LexaGene Holdings, Inc. (LXG.V) (LXXGF.QB) to help curb the spread as people cautiously return to a semi-normal life.

For more information on LexaGene Holdings, Inc. (TSXV:LXG) (OTCQB:LXXGF), please click here.

The information set forth above contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, licensing issues, ability for its product to detect SARS-CoV-2 N gene RNA and obtaining FDA approval of its products — that could cause actual results to differ materially from the Company's expectations as disclosed in the Company's documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date herein.

Readers are cautioned that the information contained is not making any express or implied claims that LexaGene or technology has the ability to eliminate the SARS-CoV-2 virus at this time. We further caution that LexaGene's technology has yet to receive FDA authorization, as the company is currently pursuing this distinction.

Disclaimer:  Microsmallcap.com (MSC) 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 MSC or any company mentioned herein. The commentary, views and opinions expressed in this release by MSC are solely those of MSC 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 MSC and FNM for any investment decisions by their readers or subscribers. MSC 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 (MSC), 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 (MSC) has not independently verified or otherwise investigated all such information. None of the Author, MSC, 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. FNM was not compensated by any public company mentioned herein to disseminate this press release but was compensated twenty five hundred dollars by MSC, a non-affiliated third party to distribute this release on behalf of LexaGene Holdings, Inc. 

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 MSC and FNM undertake no obligation to update such statements.

Media Contact:
FN Media Group, LLC
info@financialnewsmedia.com
+1(561)325-8757

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