LexaGene Holdings, a molecular diagnostics company that develops fully automated rapid pathogen detection systems, has configured a system to detect mutant sequences unique to the United Kingdom (UK, B.1.1.7) and South African (SA, B.1.351) variants of SARS-CoV-2, the pathogen that causes COVID-19.
The UK variant, known to be more contagious and possibly deadlier, was first detected in the US at the end of December and has now been identified in 33 states. Likewise, both the SA and Brazilian variants were first detected in the US at the end of January, and several cases have now been reported, suggesting more widespread infections.
The UK, SA, and Brazilian variants have now acquired mutations that may likely reduce the efficacy of approved vaccines and therapeutics.
LexaGene's MiQLab is designed for point-of-care use and for simultaneous screening of numerous respiratory pathogens, including COVID-19 strain identification. The system is open-access, which allows for new tests to be easily loaded onto the system. This is a unique feature that is not found in any other system designed for point-of-care use.
LexaGene's MiQLab is designed for point-of-care use and for simultaneous screening of numerous respiratory pathogens
Dr Jack Regan, LexaGene's CEO and Founder said: "Just three weeks ago, we designed assays to detect the UK and SA variants to demonstrate proof-of-principle that these assays could be quickly ported onto the MiQLab. After just two full workdays of having these reagents in-house, we verified our MiQLab could detect mutations associated with these variants. With proper FDA approvals, these tests could quickly be sent to MiQLabs operating at the point-of-care for faster detection, which would likely improve containment efforts for the spread of these new variants."
Regan continued: "The optimism over the increasing availability of COVID-19 vaccines needs to be tempered with the worrisome potential that some of these new variants are not only more contagious but also may render these vaccines less effective."
Regan explains that, generally, getting a new vaccine authorised for use by FDA takes six or more months, so everyone really needs to rely on better diagnostics to stop the spread of these new variants before they become more widespread and nearly impossible to contain.
"MiQLab's open-access design allows the system to be quickly configured to detect new variants at the point-of-care. As such, our technology fills a critical testing gap we have in our defences against these ever-changing pathogens," Regan added.
LexaGene is pursuing FDA EUA for COVID-19 testing using assays that are predicted to detect >99.9% of the strains circulating today based on published sequences, including the UK, SA, and Brazilian variants. At this time, LexaGene has no plans to incorporate the variant-specific tests into the initial FDA studies for Emergency Use Authorization (EUA) for COVID-19 testing.
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. To date, there is no FDA approved device that is designed for point-of-care usage and is open-access.
The company 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.
