 |
| Image created by Dr. Michael J. Miller |
Molecular diagnostics company, LexaGene, announced that it has initiated a program that uses the rapid configurability of the MiQLab™ system to investigate novel variants of SARS-CoV-2, the pathogen that causes COVID-19.
SARS-CoV-2 is a pathogen that mutates quickly. New variants were recently identified in the United Kingdom (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. Also, some scientists are concerned that the South African strain may not be a good match for developed vaccines and antibody-based therapeutics.
Dr. Jack Regan, LexaGene’s CEO and Founder states, “It is hard to estimate the impact of a new variant that can re-infect those who have already been infected or vaccinated. It is critical that we have the capability to not only detect whether the patient is COVID-19 positive, but also whether they are, in fact, infected with a new variant. We need to be able to more quickly and accurately identify new strains at the point-of-care, as this potentially could have helped better contain SARS-CoV-2 at the start of the outbreak.”
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 and South African variants. Given the suspected higher rate of transmissibility of these variants, it is of clinical importance to be able to distinguish these new variants from the original strain. LexaGene’s MiQLab can be easily 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.
Dr. Regan continues, “We founded LexaGene to fill a critical technology gap in our defenses against new pathogens. LexaGene’s MiQLab is designed to be a point-of-care system that is open-access in nature. Once a pathogen emerges or mutates, the MiQLab system is designed to quickly onboard new tests to detect a desired target, which would speed up timelines for point-of-care testing. Detecting these variants quickly inside hospitals, clinics, and other testing locations maximizes the chances of successfully containing these new threats.”
To date, there is no FDA approved device that is designed for point-of-care usage and is open-access.
LexaGene has designed and ordered components for tests to distinguish the UK and South African strains from the traditional coronavirus strain and will confirm these work as expected on the MiQLab system
At this time, LexaGene has no plans to incorporate these new tests into the FDA studies for Emergency Use Authorization (EUA) for COVID-19 testing, which began late last month.
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.