MiQLab is a fully automated genetic analyzer designed to deliver reference-quality data at the point-of-need. The technology screens samples for up to 27 different targets at once -- looking for pathogens and/or antimicrobial resistance factors -- and returns results in approximately one hour. It is designed to be operated at the site of sample collection to avoid the delay associated with shipping and manually processing samples.
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LexaGene said the technology can be used in multiple billion-dollar markets, including human and veterinary diagnostics as well as food safety testing.
“We started this company with a vision to create a technology that the world needs, particularly during these difficult times as we struggle to contain the spread of COVID-19,” LexaGene CEO Dr Jack Regan said in a statement.
“We have finished incorporating the feedback from beta testing and have begun manufacturing our commercial instrument, the MiQLab genetic analyzer. It is extremely gratifying to be so close to the start of selling this much-needed technology.”
MiQLab is open-access, which allows users to customize their tests easily. The company said comparable point-of-need instruments that allow for easy assembly and performance of highly multiplexed tests are not commercially available in a market valued at $20 billion.
For example, scientists who have custom testing needs make up the open-access market, and they currently spend hours a day to manually perform PCR testing. These same individuals will now have the opportunity to save hours a day by having MiQLab automate the processing of their own tests, LexaGene noted.
“We are not only manufacturing the device, but also the associated consumables for our razor blade business model,” Regan said. “Our consumables include the single-use disposable cartridge for sample preparation as well as the PCR test chemistry, which MiQLab automates.”
At volume manufacturing, LexaGene said it expects the costs for its consumables to be substantially lower than competing technologies, which will allow the company to maintain healthy profit margins even when selling into cost-sensitive markets.
Offering three sets of chemistries
To start, the company said it anticipates offering three sets of chemistries, namely, a COVID-19 test, a bacterial and antimicrobial panel for veterinary diagnostics that will screen for eight different pathogens (E. coli, Proteus, Klebsiella, Enterobacter, Pseudomonas, Staphylococcus, Streptococcus and Enterococcus) and 12 antibiotic resistance factors including methicillin and vancomycin resistance, and an open-access panel to facilitate customized genetic testing.
LexaGene has submitted a preliminary plan for COVID-19 testing to the US Food and Drug Administration and is still in conversations with the agency regarding the proposed studies for its technology.
As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
The company’s stock recently traded up by 16% to $0.83 a share in New York and rose by 15.3% to C$1.13 a share in Canada.
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