GREAT NEWS. They're going for the whole enchilada!
LexaGene Intends to Pursue Full Panel Pathogen Testing through the FDA
November 24, 2021 16:00 ET | Source: LexaGene Holdings Inc
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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.
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