LexaGene Holdings Inc. (OTCMKTS:LXXGF) stock is trading slightly higher in Friday’s trading session. The stock has fallen 21% over the past 6-month.
Market Action
As of 10:39, LXXGF stock is up by 0.50% to $0.5427 with more than 470k shares, compared to its average volume of 344K shares. The stock has moved within a range of $ 0.5250 – 0.5700 after opening the trade at $0.55.
Major Trigger:
LexaGene Advances Towards FDA Emergency Use Authorization
Key Highlights:
- LexaGene Holdings announced it continues to systematically advance the MiQLab™ System to meet the Food and Drug Administration (FDA) criteria for Emergency Use Authorization (EUA). The MiQLab System is a first of its kind, point of care diagnostic testing technology.
- The FDA EUA process requires novel diagnostic devices to undergo a substantial amount of complex design control and testing. All functions for critical system operation must be validated and submitted as part of the process.
Key Quote:
Dr. Jack Regan, LexaGene’s Founder and CEO, stated, “The MiQLab systems we’ve sold into veterinary diagnostics and the biologics manufacturing market are in the field and working as designed. 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. Over the last few months, LexaGene has made great progress and completed many of these requirements. 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.”
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