- LexaGene (LXG) has completed the analytical studies required by the FDA for emergency use authorization (EUA) of its MiQLab for COVID-19 testing
- MiQLab is a flow-through PCR system that delivers fast and reliable results in a short amount of time
- Once the FDA approves MiQLab for COVID-19 testing, LexaGene expects that it will be classified as a class II medical device
- LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing
- LexaGene Holdings Inc. (LXG) is up 10 per cent, trading at $0.55 per share
LexaGene (LXG) has completed the analytical studies required by the FDA for emergency use authorization (EUA) of its MiQLab for COVID-19 testing.
MiQLab is a flow-through PCR system that delivers fast and reliable results in a short amount of time. Once the FDA approves MiQLab for COVID-19 testing, LexaGene expects that it will be classified as a Class II medical device.
As such, the process of preparing its point-of-care (POC) fully-automated PCR system for evaluation by the FDA is considerably more complex than if it were simply submitting only a COVID-19 PCR test chemistry for FDA authorization.
Dr. Jack Regan, CEO and founder of LexaGene, is optimistic that the company will receive FDA approval once testing is complete.
“Our next step,” he said, “is to have a third party conduct a COVID-19 clinical evaluation using the MiQLab System at both a POC testing facility and a clinical laboratory, and then the analytical and clinical data will be compiled and submitted to the FDA for authorization.”
“This milestone should be viewed as having much broader implications than COVID-19 testing only,” added Dr. Regan. “If we are successful in being authorized for COVID-19 testing, we will follow this work with studies to support 510(k) applications for complex diseases in human clinical medicine.”
Until the FDA grants LexaGene’s system EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing.
LexaGene Holdings Inc. (LXG) is up 10 per cent, trading at $0.55 per share as of 10:59 am ET.