- LexaGene Holdings Inc. (LXG) is continuing to advance its MiQLab System to meet the FDA’s criteria for Emergency Use Authorization
- The FDA Emergency Use Authorization (EUA) process requires novel diagnostic devices to undergo complex design control and testing
- The MiQLab System has already been deployed in multiple real-world settings, including veterinary diagnostics and biologics manufacturing
- The company hopes to utilize the MiQLab System to combat COVID-19 once it has gained FDA approval
- LexaGene Holdings Inc. (LXG) is holding steady, trading at $0.68 per share
LexaGene Holdings Inc. (LXG) is advancing its MiQLab System to meet FDA criteria for Emergency Use Authorization.
The MiQLab System, a first-of-its-kind point of care diagnostic testing technology, has already been deployed in multiple real-world settings.
Dr. Jack Regan, LexaGene 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,” he added, “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 FDA Emergency Use Authorization (EUA) process requires novel diagnostic devices to undergo complex design control and testing.
“We are making great strides on the remaining requirements,” remarked Steve Armstrong, LexaGene COO. “Namely, we are in the process of verifying our longer reagent shelf-life.”
He added that the company is working on the following steps to ensure a successful EUA submission:
- Completing system software validation, including error handling
- Verifying an automated scheduler and refining standard scripts for automation
- Verifying thermal and optical parameters for optimal PCR amplification
- Validating the signal processing algorithm and ensuring reports are consistently accurate
- Making process improvements in order to scale manufacturing
The company hopes to utilize the MiQLab System to combat COVID-19 once it has gained FDA approval.
“Coronavirus continues to present a real danger in the United States and internationally,” added Mr. Armstrong. “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.”
LexaGene is a molecular diagnostics company that develops molecular diagnostic systems.
The company develops systems for on-site rapid testing in veterinary diagnostics, food safety, and in markets such as clinical research, agricultural testing, and biodefense.
LexaGene Holdings Inc. (LXG) is holding steady, trading at $0.68 per share as of 1:21 pm ET.