Molecular diagnostics company, LexaGene, announce that it has started a series of studies required by the FDA for Emergency Use Authorization (EUA) testing for its COVID-19 assay in a point-of-care (POC) environment using its fully automated MiQLab™ system.
Dr. Jack Regan, LexaGene’s CEO and Founder states, “I’m excited we have progressed to the point where we have started our FDA study. Our open-access technology is unlike any other on the market today, as it could be configured quickly to detect new variants, such as the recent UK variant (aka SARS-CoV-2 VUI 202012/01). Since our system is capable of high multiplexing and is microfluidic in nature, it is easy to add newly developed Polymerase Chain Reaction (PCR)tests to detect variants that are either poor matches to the vaccines or are resistant to any developed therapies, which is critical to help get this pandemic under control.”
The majority of tests authorized by the FDA for COVID-19 testing are reagent-only chemistry tests that can only be used by trained professionals in the 17,432 high complexity reference laboratories in the United States. These laboratories generally take at least a day and sometimes as much as a week or more to return results, which greatly complicates contact tracing. To speed up time-to-result, the FDA has prioritized submissions for POC testing solutions, where results can be generated on-site, soon after collecting the sample. To help address this problem, LexaGene anticipates submitting to the FDA for POC use status for its MiQLab system so that the Company can provide COVID-19 tests to the locations that need it most. There are 193,474 locations certified to run POC tests in the United States, making for a much larger market opportunity than the high complexity laboratories alone.
For vendors submitting to the FDA EUA program, more studies are required for authorization to sell into POC environments than are required for selling into high complexity laboratories. This is because POC PCR tests are automated, and the FDA must evaluate the hardware, software, firmware, consumables, and chemistry associated with the test. Furthermore, they must also evaluate whether the technology is easy enough to use and has a low risk for erroneous results. These added studies make submissions for POC testing considerably more complex than submissions for simple reagent-only chemistry tests that are used in high complexity reference laboratories.
Dr. Regan concludes, “Obtaining FDA authorization for use at a POC setting is a complicated and time-consuming process especially for a novel technology such as LexaGene’s where FDA had no prior opportunity to evaluate the MiQLab System. We are confident that we can demonstrate to FDA the value of the MiQLab system and its COVID-19 assay to combat this pandemic through POC testing. I look forward to having deeper conversations with the FDA and presenting our data to them.”
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.
LexaGene is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time.
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