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Rob,

This is how they are different:

1. Visby has an EUA for use in moderate complexity labs. This means only labs with trained personnel can run the test. From Visby's press release: "This test has been authorized by FDA under an EUA for use by authorized laboratories". LexaGene is going for point of care (POC) authorization. This is a far more difficult authorization to obtain. If they obtain an EUA for POC this means that anyone can run the test (no training required) in locations as diverse as hospital ER's, doctor's offices, schools, stadiums, border crossings, i.e., at the point of care not at a lab.

2. Visby's test is singleplex. It is testing for 1 pathogen, Covid-19. From Visby's press release: "This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens". Lexagene's is multiplex, testing for 27 different pathogens. The open access capability means one can test for literally any virus, bacterium, or fungus.

3. Visby's test is not quantitative. It just gives a yes or no answer. Lexagene's is quantitative. It tells the exact amount of the pathogen present.

4. Visby's is a simple device used only for Covid-19 testing. Lexagene's MiQLab is a device that can be used in multiple industries: Covid-19 testing, vaccine manufacturing, food safety, veterinary. The use cases are limitless.

Eph97
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