LexaGene is a molecular diagnostics company based in Beverly MA. Their signature product, MiQLab, is an automated pathogen detection system. The system is designed to work in point of care scenarios (think Doctor's office, vet clinics, etc) where non scientists are able to collect samples, insert them into the machine and receive results in less than 1 hr. Traditionally this is done by collecting samples at a doctors office, vet clinic, etc and shipping them out to a lab to be analysed, which can be a 3-5 day process or performing a PCR test manually which requires highly skilled labor.
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The technology applies a proprietary RT-qPCR based method (Gold Standard in testing) to analyse each sample's contents for up to 27 different pathogens which will not only allow doctors or other professionals to rapidly determine the cause of infection but also identify whether the infection is resistant to commonly prescribed antibiotics, within just one hour. (AMR). There will be more details provided below on LexaGene, its ability to detect AMR and the bigger push behind these efforts from the US Federal Government.
The company was founded in 2016 and went public on the TSX venture exchange in order to raise funds. Dr. Jack Regan founded the company following the work he did at Lawrence Livermore National Laboratory. The government used the technology he helped to develop after a decade and $20m+ of R&D resources to test for bio-threats (anthrax, plague, small pox, etc). MiQLab is the next generation of this technology where Dr. Regan licensed the underlying IP from Livermore National Laboratory.
As of January 8th, 2021, LexaGene has 35+ employees, and $11.3m in treasury.
For the background story on Livermore National Laboratory and Lexagene see this article:
Livermore Lab and LexaGene's LX6: A Rapid and Sensitive Pathogen Detection System | Federal Labs
The company was founded to initially tackle the veterinary diagnostics space due to the limited amount of hurdles required to sell into here (ie, no FDA approval needed). However, in March following COVID, they started to work on applying for the FDA's EUA (Emergency Use Authorisation) which fast-tracked FDA approvals for technology/solutions that can help fight/maintain COVID. LexaGene viewed this as a unique opportunity to accelerate their entrance into the human diagnostics space. They started their FDA EUA study in December 2020.
MiQLab is a system that has the ability to screen for 27 pathogens at once while also providing higher confidence in results. These results are typically completed in ~1hr, and are designed for point of care use where non technical-operators can perform the tests.
Polymerase Chain Reaction (PCR), is considered to be the gold standard in pathogen detection and pathogen diagnostics. LexaGene automated the PCR process and moved it to the point of care (POC) while providing quicker results. The automation of PCR could increase the effectiveness and speed of the detection of new pathogens like COVID-19. Also, as PCR is currently done manually, the automation process would erase the need for highly trained personnel to perform tests and would steer clear of any inefficiencies due to human error. The company has claimed that unskilled workers can be trained in as little as one hour to operate the MiQLab, and that there is no complex work involved like pipetting of fluids.