LexaGene Intends to Pursue Full Panel Pathogen Testing through the FDA
LexaGene Holdings, Inc. (OTCQB: LXXGF) announced plans to pursue 510k clearance and CLIA-waiver from the FDA for its MiQLab System™, designed for syndromic testing at the point of care. The MiQLab allows simultaneous testing for multiple pathogens and antimicrobial resistance, addressing the global threat of drug-resistant infections. The company has opted to discontinue its EUA application for COVID-19 testing to focus on broader pathogen testing instead. With ongoing sales in veterinary and research markets, LexaGene aims to fulfill FDA requirements for human clinical diagnostics.
- Pursuing both 510k clearance and CLIA-waiver could enhance product accessibility and market reach.
- MiQLab System targets multiple pathogens and antimicrobial resistance, addressing critical healthcare needs.
- Transitioning from COVID-19 EUA to broader pathogen testing aligns with long-term strategic goals.
- Current operations are limited to Research Use Only until FDA authorization is obtained.
- Discontinuation of COVID-19 testing may impact revenue streams.
BEVERLY, Mass., Nov. 24, 2021 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing, today announced it intends to pursue both 510k clearance and CLIA-waiver from the FDA to utilize the full potential of the MiQLab System™ for syndromic testing at the point of care.
Syndromic testing allows medical providers to simultaneously test patient specimens for multiple pathogens that produce overlapping signs and symptoms. MiQLab’s broad multiplexing provides this capability and also allows for testing other clinically important markers such as antimicrobial resistance genes. Antimicrobial resistance is widely considered to be the next global pandemic.1 Scientists estimate that drug resistant pathogens will kill ~10 million people per year by the year 2050.2
Dr. Jack Regan, LexaGene’s Founder and CEO stated, “One of the hardest challenges in medicine is to rapidly identify, at the point-of-care, the exact cause of complex and difficult to treat infections.3 We’ve developed the MiQLab to tackle this challenging problem. It is capable of processing sample types that traditionally inhibit PCR (e.g., urine and fecal samples) and screens for up to 27 targets including drug resistance markers so it can be used in the fight against superbugs. We believe the MiQLab will be on the forefront of helping clinicians accurately diagnose and treat their patients at the point of care so that a pandemic caused by antimicrobial resistant pathogens can be avoided. Similarly, syndromic panels like respiratory or gastrointestinal panels will enable clinicians to more rapidly and conveniently diagnose infectious diseases, enabling earlier treatment and prevention.”
The Company has been steadily working to meet FDA requirements for human clinical diagnostics. The progress we have made during the pursuit of EUA for COVID-19 testing has brought the Company closer toward meeting the more extensive requirements of the traditional premarket review pathway, which will be required for the Company to offer broad panel pathogen testing at the point of care. The FDA recently provided industry-wide guidance4 and based on this guidance and direct communications with the agency, the Company has decided it will no longer pursue an EUA application for COVID-19, but instead pursue 510k and CLIA-waiver for broad-panel pathogen testing, thereby allowing the Company to focus on providing the MiQLab technology for its intended use of syndromic testing at the point of care.
LexaGene’s MiQLab system is unique in that it is a flow-through PCR system. To LexaGene’s knowledge, the FDA has never received an application for a flow-through PCR system for use in human clinical diagnostics. Until the FDA grants LexaGene’s system authorization for human clinical diagnostics, all work using LexaGene instruments is classified as Research Use Only.
The Company continues to sell its technology into veterinary hospitals, bio-pharmaceutical manufacturers, and other open-access markets.
To learn more about LexaGene and the MiQLab System or subscribe to company updates, visit www.lexagene.com, or follow us on Twitter or LinkedIn.
On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman
Corporate & Media Contact:
Gail Winslow
Director, Marketing
gwinslow@lexagene.com
978.482.6237
Investors:
ir@lexagene.com
800.215.1824
About LexaGene Holdings Inc.
LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing, and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go’. The MiQLab™ system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately two hours. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.
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.nature.com/articles/s41591-020-01201-9#:~:text=Antibiotic%20resistance%20(AR)%20is%20widely,much%20less%20likely%20to%20succeed.
2] https://www.chemistryworld.com/features/the-antibiotic-countdown/3008544.article
3] https://www.cdc.gov/drugresistance/biggest-threats.html
4] https://www.fda.gov/media/135659/download
FAQ
What is LexaGene's plan for the MiQLab System?
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Why did LexaGene discontinue its EUA application for COVID-19 testing?
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