LexaGene Holdings Inc (CVE:LXG) (OTCQB:LXXGF) has launched an early access program for its MiQLab pathogen detection system aimed at the veterinary and open-access markets, the company announced Monday.
In a general corporate update, the company said that it is rebounding from supply chain challenges imposed by the coronavirus (COVID-19) pandemic, has US$11.3 million in its treasury and has begun testing MiQLab.
“Our MiQLab pathogen detection system has 230 unique components,’ CEO Jack Regan said in a statement. “Over the summer, the coronavirus pandemic caused some supply chain issues for several key components that delayed the manufacturing, optimization and testing of these systems. Just recently, these supply chain issues were resolved and we are now testing and optimizing our MiQLabs.”
That’s where the early access program comes in. The idea is to target opinion leaders in the veterinary and open-access sectors in order to support future sales efforts. LexaGene said it expects to ship the first units for the program by the middle of the fourth quarter.
LexaGene’s MiQLab is also capable of purifying genetic material from a complex nasal or saliva sample, assembling and performing a multiplexed SARS-CoV-2 ( the virus that causes COVID-19) PCR test, and reporting results in an automated fashion.
The company said it is working to become the first company to put an open-access, fully automated, sample-to-answer coronavirus testing system system through the FDA’s Emergency Use Authorization (EUA) process.
This is a unique challenge, the company said, compared to other companies that are simply looking to clear a PCR chemistry test through the FDA that can only be used in certified laboratories. LexaGene’s plan is to put forth not only a PCR test but also an automated system simple enough to be used in near-patient settings.
If it works, automating the test in near patient settings could reduce the time it takes to get a coronavirus test result down from days to only one hour.
LexaGene is preparing for a clinical study of its system later this year, and the company announced that it has signed a clinical evaluation study agreement with the Dartmouth Hitchcock Medical Center, which will conduct the study in its laboratory.
Until the proposed studies are completed and the FDA grants LexaGene’s MiQLab EUA for COVID-19 testing, LexaGene’s system and the associated tests cannot be used for clinical diagnostics, the company said.
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