LexaGene Holdings moves toward FDA emergency use authorization of its MiQLab diagnostic system

LexaGene Holdings Inc (OTCQB:LXXGF) (CVE:LXG) (FRA:5XS2) told investors that it continues to systematically advance its MiQLab System to meet the US Food and Drug Administration’s (FDA) criteria for Emergency Use Authorization (EUA), including passing electrical safety testing and ship testing.  The FDA EUA process requires novel diagnostic devices to undergo a substantial amount of complex design control and testing, the company said, and all functions for critical system operation must be validated and submitted as part of the process.  “The MiQLab systems we’ve sold into veterinary diagnostics and the biologics manufacturing market are in the field and working as designed,” CEO Jack Regan said in a statement. “Part of our strategy is to use these systems in real-world settings, processing complex samples, to ensure our technology is ready to pass the stringent FDA requirements. The intent of the FDA requirements is to ensure vendors take the necessary steps to get the highest quality product possible out of their specific technology.” READ: LexaGene sells its MiQLab diagnostic testing system to Meridian Veterinary Capital in Dallas “Over the last few months, LexaGene has made great progress and completed many of these requirements,” Regan continued. “Namely, we have passed electrical safety testing, passed ship testing, finalized our master mix and carrier fluid formulation, finalized our test assays and their configuration, finalized our internal amplification control and internal process control, and completed our user manual to a state acceptable for an EUA submission.” COO Steve Armstrong laid out what remains to be done. “We are making great strides on the remaining requirements,” Armstrong said. “Namely, we are in the process of verifying our longer reagent shelf-life (ie, stability of our onboard reagents). We are also working on completing system software validation, including error handling. We’ve also been working on verifying an automated microfluidic scheduler as well as further refining our standard scripts for automated sample preparation and assay assembly.”  “We continue work required to verify our thermal and optical parameters for optimal PCR amplification. Likewise, we are working on validating our signal processing algorithm and ensuring our reports are consistently accurate. Finally, we are making process improvements so we can scale manufacturing. Once the company fully completes these necessary steps, the MiQLab will be fully optimized and ready for analytical and point-of-care clinical validation for EUA submission.” Veterinarians using MiQLab for in-clinic testing have increased confidence in prescribing the most appropriate antibiotic and keeping pet owners at ease knowing their loved ones are receiving the best possible care, the company said. In addition to its veterinary applications, the MiQLab System also has potential in the field of coronavirus (COVID-19) diagnostics. MiQLab can test for 27 pathogens and returns results in about one hour versus 1-3 days at a lab. “Coronavirus continues to present a real danger in the United States and internationally,” Armstrong added. “The MiQLab is perfectly positioned to address this large and critically important market. LexaGene is eager to complete the FDA requirements as quickly as possible. To date, no novel fully integrated sample-to-answer, multiplex technology has made it through the EUA application process. LexaGene’s MiQLab may be the first.” “For our EUA application, we are taking a very methodical approach to this work. We look forward to the day when the MiQLab is being used as a valuable asset in the fight against COVID-19 and its deadly variants.” Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com Follow him on Twitter @andrew_kessel