Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains.

“Just three weeks ago, we designed assays to detect the U.K. and [South African] 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,” said Jack Regan, CEO and founder of Beverly, Mass.-based Lexagene. “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.”

Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA. The POC path requires evaluation of the hardware, software, firmware, system security, and consumables involved in the test process in addition to analysis of the assay’s performance, reagent stability and error rate when used by individuals not trained as laboratory professionals.

To keep from delaying authorization, the company does not plan to add the variant specific tests to those studies. The assays submitted are predicted to detect more than 99.9% of strains currently in circulation as indicated by published sequences, including the U.K. (B.1.1.7), South African (B.1.351) and Brazilian (P.1) variants.

Moving from detection to strain identification

Lexagene’s current assay targets very conserved regions of the SARS-CoV-2 genome and can readily determine whether someone is infected with any of the variants. Adding strain-specific assays to the multiplex would enable better tracking of the current variants of concern, which are estimated to be about 50% more contagious than the variant that dominated the world in 2020. Tracking the spread of the variants could inform the development of updated vaccine formulations or booster shots, if required.

“An ideal application of Lexagene’s technology is to rapidly enable strain identification at the point-of-care,” Regan told BioWorld. “The Miqlab is arguably the only system designed to work at the point-of-care where strain identification could be rapidly deployed.”

Recent letters to the New England Journal of Medicine provided topline results of studies showing that the Moderna and Pfizer-Biontech mRNA vaccines produce lower levels of neutralizing titers against the B.1.351 variant, though they are still expected to be protective. The P.1 variant shares many of the same mutations as B.1.351 and many researchers expect that the vaccines will have a lower level of neutralization against it. More concerning, P.1 appears to be able to reinfect individuals who have already had COVID-19.

“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,” Regan said.

Adapting with the virus

The Miqlab uses a completely automated process to detect up to 27 different pathogens in one hour using gold standard real-time PCR chemistry. The point-of-care device offers highly accurate diagnosis without the delays of days or weeks seen for PCR testing sent to centralized laboratories throughout much of the pandemic. For a more infectious variant, detection of new cases in hours could provide vital information for control, potentially before it spreads widely in a community.

“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 defenses against these ever-changing pathogens,” noted Regan.

The open-access tests can be synthesized at scale and shipped a week or two after identification of a new strain of SARS-CoV-2 or a new pathogen. Closed access point-of-care systems with fully embedded consumables may take six to eight weeks to develop and distribute updated assays.

“Once the FDA approves the technology,” Regan added, “we are hopeful the agency will recognize the need for point-of-care strain identification and clear the path for this to happen.”