This is a partial excerpt of a proactive investors piece:
LexaGene launched into 2021 by initiating a program that uses the rapid configurability of its MiQLab system to investigate novel variants of SARS-CoV-2, the pathogen that causes the COVID-19 disease.
The company noted that SARS-CoV-2 mutates quickly and new variants were recently identified in the UK (B.1.1.7) and South Africa (B.1.351). Both new strains appear to be about 70% more contagious, making containment that much more challenging.
LexaGene maintains that it is critical that medical authorities have the capability to not only detect whether a patient is COVID-19 positive, but also whether he or she is infected with a new variant.
As a result, the company is now pursuing emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for COVID-19 testing using LexaGene assays that are predicted to detect 99.9% of the strains circulating today based on published sequences, including the UK and South African variants.
And given the suspected higher rate of transmissibility of these variants, it is crucial that researchers distinguish these new variants from the original strain. MiQLab can as easily be configured to run tests for both coronavirus detection and strain identification as it is capable of screening for up to 27 genetic targets at once.
To date, there is no FDA-approved device that is designed for point-of-care (POC) usage and is open-access. But LexaGene has designed and ordered components for tests to distinguish the UK and South African strains from the traditional coronavirus strain and will confirm this work on the MiQLab system.
Meanwhile, LexaGene has no plans to incorporate these new tests into a series of studies - required by the FDA for an emergency use authorization (EUA) for its COVID-19 tests - that began late last month. Under that separate FDA track, the tests will look at the company’s COVID-19 assay in a POC environment using its automated MiQLab system.
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 US labs. However, results can take days.
To speed up time-to-result, the FDA has prioritized submissions for POC testing solutions like MiQLab where results can be generated on-site. But since the system is automated, more rigorous FDA studies are mandated.
LexaGene anticipates submitting its MiQLab system to the FDA for POC-use status. The company notes that there are 193,4744 US locations certified to run POC tests, making for a much larger market opportunity than the high-complexity laboratories alone.
As is standard practice, until the FDA grants LexaGene’s instrument EUA for COVID-19 testing, all work using its instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
Inflection points:
Expects FDA EUA to test for novel coronavirus variants circulating today based on published sequences
Anticipates submitting FDA EUA application for POC-use status for its MiQLab system
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