NEW YORK, June 1, 2020 /PRNewswire/ -- As the first wave of COVID-19 begins to wane, and the second wave threatens to extend the pandemic well into the latter half of 2020, the medical community remains focused largely on two areas: detecting the virus, and treating the virus. By advancing these goals, health experts will not only be able to limit the spread of the disease, they would also be empowered to potentially end the pandemic once and for all. Though no organization can lay claim to these goals yet, among the many companies working on pathogen detection or treatment initiatives, a few stand out from the crowd for the speed, accuracy, and or broad applicability of their solutions. Through their offerings, these companies—namely, LexaGene Holdings Inc. (TSX-V:LXG) (OTCQB:LXXGF), Medmira (TSXV:MIR), Gilead Sciences, Inc. (NASDAQ:GILD), Novartis AG (NYSE:NVS), and Novavax Inc. (NASDAQ:NVAX) — can assist in reducing the impact of the novel coronavirus in terms of both economic and societal damage.
LexaGene's Open-Access, Multiplex Molecular Diagnostic Analyzer
The goal of LexaGene Holdings Inc (LXG.V) (LXXGF.QB) is to develop genetic analyzers for the rapid detection of pathogens, as well as other molecular markers. This makes it uniquely suited to deliver solutions that address COVID-19.
Beginning on January 27, long before the viral outbreak was labelled a pandemic by the World Health Organization, LexaGene addressed how its flagship offering, the LX Analyzer, can be used to detect and to ultimately help the public respond to the virus. The instrument is capable of detecting pathogens at the point-of-need in just one hour. This eliminates long wait times and the need to transport the sample from sick individuals to laboratories for manual processing.
However, the two most notable aspects of the LX Analyzer are that it is both an "open-access" and "multiplex" molecular diagnosis instrument.
Its open-access feature allows users to quickly introduce newly developed assays into the platform for fully automated and rapid detection of pathogens, even novel ones like COVID. This is how LexaGene Holdings Inc (LXG.V) (LXXGF.QB) scientists were able to detect the virus behind the current pandemic by quickly adapting the Center for Disease Control's diagnostics panel to the LX Analyzer.
What's more, the platform's ability to screen for multiple pathogens at once represents a remarkable improvement over competing, "singleplex" diagnostic tools. The LX Analyzer can screen for up to 27 different pathogens in a single sample, greatly reducing the time necessary to identify the presence of antibiotic resistance and thereby detect the pathogen in a patient's body.
In addition to faster results, the multiplex component of the LX Analyzer allows the instrument to return more accurate results. Singleplex tests are more likely to return a false positive or false negative result, where the instrument detected the presence of pathogens similar to the ones being screened for. This is especially a problem with the SARS and MERS viruses. By contrast, the LX Analyzer can rule out the presence of other infectious diseases, leading to a more accurate result.
LexaGene Holdings Inc has already filed a patent application to the US Patent and Trademark Office to protect the expanded testing capabilities of the LX Analyzer as it applies to COVID-19 and plans to launch the instrument in the third quarter of 2020. In addition, the company has also submitted its plan to the FDA for Emergency Use Authorization (EUA) for detecting the virus. The company expects to complete the necessary studies for this milestone in the near future.
Concurrent Pathogen Detection Instruments and Vaccine Candidates
Joining LexaGene Holdings Inc (LXG.V) (LXXGF.QB) in its effort to quickly and accurately detect COVID-19, and thus limit the harm it can do, is Medmira (TSXV:MIR). To this end, Medmira recently signed a deal with Webb Diagnostic Technologies for that company to distribute its "Reveal" Antibody Test. This test detects antibodies to SARS-CoV-2 in serum and plasma, as well as whole blood. It also detects all human immunoglobulins, as opposed to just IgM/IgG, which most competing tests screen for, meaning it can identify previous and present infections in patients.
However, if detecting the virus is the first step to combating the outbreak, the final step is developing a treatment. Several companies are currently advancing potential vaccines that could be commercially available within the next year.
For example, Gilead Sciences, Inc. (NASDAQ:GILD) is developing Remdesivir as an investigational antiviral treatment. Remdesivir has been identified as having the potential to impact SARS-CoV-2 in lab results, though considerably more testing is needed to determine if it is both safe and effective. Nevertheless, Gilead recently signed a licensing agreement with five generic drugmakers to make Remdesivir for 127 countries.
Likewise, Novartis AG (NYSE:NVS) has partnered with Massachusetts General Hospital to develop a SARS-CoV-2 vaccine candidate. The company's subsidiary—AveXis, a gene therapy unit—will work towards advancing a potential vaccine based on a previous treatment called Zolgensma, which it developed for spinal muscular atrophy. Clinical trials are scheduled to begin in the second half of 2020.
Finally, Novavax Inc. (NASDAQ:NVAX) has begun enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX‑CoV2373. This candidate is a stable, prefusion protein made using its proprietary nanoparticle technology. To hasten the development of NVX, the Coalition for Epidemic Preparedness Innovations (CEPI) has provided Novavax with up to $388 million in funding.
Too Early to Predict Outcome, But Rapid Detection Instruments and Vaccine Candidate Advancements Provide Hope
While LexaGene Holdings Inc (LXG.V) (LXXGF.QB) and Medmira (MIR.V) are readying to bring next-gen pathogen detection instruments to market, Gilead Sciences, Inc. (GILD), Novartis AG (NVS), and Novavax Inc. (NVAX) are racing to offer a potential treatment for COVID-19.
No reliable timeline for a return to normal can be established without both accurate detection and a scientifically supported indication of a cure. In the meantime, the companies listed here can do their part to curb the ongoing outbreak as the first wave gives way to the very real threat of a second wave.
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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