LexaGene Verifies CDC Monkeypox Assay Works on MiQLab System and Readies Company Should an EUA be Declared
LexaGene Holdings (OTCQB: LXXGF) announced that its MiQLab® System can perform the CDC Monkeypox real-time PCR test. Following the WHO's declaration of Monkeypox as a public health emergency on July 23, 2022, and subsequent U.S. emergency declaration on August 4, the system aims to address potential infection spikes during back-to-school activities. The MiQLab System, designed for rapid pathogen detection, positions LexaGene to pursue FDA EUA once declared, although no claims of curing or containing Monkeypox have been made.
- MiQLab System can conduct CDC Monkeypox PCR tests, enhancing its utility during public health emergencies.
- Positioned to pursue FDA EUA for Monkeypox testing, which could expand market opportunities.
- Currently no FDA EUA granted, which limits immediate market impact.
BEVERLY, Mass., Aug. 29, 2022 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), an innovative, molecular diagnostics company that has commercialized the MiQLab® System for automated, genetic testing, announces the System can perform the Centers for Disease Control and Prevention (CDC) Monkeypox real-time PCR test.1
On July 23rd, the World Health Organization declared Monkeypox a public health emergency of international concern,2 and on August 4th, the United States government declared the epidemic a public health emergency.3 There is concern that back-to-school activities could result in a spike in infections.
Monkeypox is a viral disease for which there is no known cure. Symptoms include fever, swollen lymph nodes, and a rash that forms blisters. Symptoms can be severe, particularly in children, pregnant women and immunocompromised individuals. Occasionally, Monkeypox can be deadly. There is also evidence this virus can be spread from humans to dogs,4 prompting interest from the veterinary community in diagnosing this disease.
Dr. Jack Regan, LexaGene’s Founder and CEO stated, “During the COVID-19 pandemic, we advanced our Company and our technology. The FDA has not yet declared an EUA for this epidemic, but should one be declared, LexaGene is in position to pursue such an authorization. The MiQLab System is a platform that can be quickly configured to detect any new pathogen and for this reason we continue to advance it as a solution for rapidly detecting newly emergent pathogens at the point-of-care.”
The company is not making any expressed or implied claims that its product has ability to eliminate, cure or contain Monkeypox at this time. Should an EUA be declared for Monkeypox, LexaGene’s management will take many factors into consideration when deciding whether to pursue such an authorization.
For more information about LexaGene and the MiQLab System, please visit www.lexagene.com or follow us on Twitter or LinkedIn.
About LexaGene Holdings Inc.
LexaGene is a molecular diagnostics company that has commercialized the MiQLab System for fast and easy detection of pathogens and other molecular markers. The System is designed for on-site usage and uses real-time PCR chemistry. Our customers include veterinary hospitals and reference laboratories – as well as contract biologic manufacturers. The MiQLab System delivers excellent sensitivity, specificity, and breadth of detection.
The TSX Venture Exchange Inc. has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
This news release 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, and licensing issues -- 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 of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
1 https://www.cdc.gov/poxvirus/monkeypox/pdf/PCR-Diagnostic-Protocol-508.pdf
2 https://www.who.int/europe/news/item/23-07-2022-who-director-general-declares-the-ongoing-monkeypox-outbreak-a-public-health-event-of-international-concern
3 https://www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html
4 https://www.msn.com/en-in/news/other/first-known-human-to-dog-monkeypox-transmission-reported-in-france/ar-AA10Qblo#:~:text=The%20first%20known%20human-to-dog%20transmission%20of%20monkeypox%20involving,for%20isolation%20from%20pets%20and%20proper%20waste%20management
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