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New York, NY – May 29, 2020 – 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 the potential 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.
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.
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