Lexagene Holdings Inc. started a series of studies for submission to the U.S. FDA for emergency use authorization (EUA) for its point-of-care system and adaptable COVID-19 assay. The open-access technology enables rapid configuration for new COVID-19 variants such as the U.K. strain now rapidly spreading around the world. The portable system requires minimal hands-on time and produces PCR test results in about an hour.

“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 U.K. variant,” said Lexagene CEO and Founder Jack Regan. “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 company initially planned to complete the studies for COVID-19 testing authorization in moderate and high complexity reference labs, which would be the standard path for reagent-only chemistry tests used by laboratory professionals. Because the turn-around time from these labs takes at least a day and at several points during the pandemic has lagged by two weeks or more in hard-hit regions, the FDA has prioritized submissions for point-of-care (POC) devices that can produce results quickly onsite.

“Given our system is really designed for POC testing, we have decided to pursue the more rigorous studies to get this category of regulatory approval,” Regan told BioWorld. The POC path requires more studies than a chemistry-only test would as it includes evaluation of the hardware, software, firmware, system security, and consumables involved in the test process as well as analysis of the assay’s performance and reagent stability in a variety of situations.

The FDA also assesses the ability for individuals not trained as laboratory professionals to use the technology with a low risk of error, the technology’s sensitivity to user and operational condition variability, and its performance compared to both reference lab and other point-of-care technology. Reliability of results will be particularly important for Beverly, Mass.-based Lexagene as the company expects that the Miqlab system will be used by large employers and educational institutions as well as clinics.

With the study just beginning and so many variables, the company hopes to complete testing, submit results, and obtain authorization as soon as possible, but the timeline remains unclear. “Some of the work we need to complete is dependent on third parties, who are currently over-burdened by the pandemic,” Regan noted. “It is impossible to estimate the challenges the pandemic may present, so at this time, we feel uncomfortable making predictions on how long these studies will take. We will use every resource possible to get through the FDA as quickly as we can.”

The system is currently available in the U.S. and Canada for research use only, though the company plans to offer the technology worldwide as it obtains regulatory approvals.

Classic COVID first

Miqlab offers a fully automated testing process that requires just a minute of hands-on time. Users load a patient sample into a single-use cartridge, fill tiny vials with the chemistry, and assign a patient code. The system takes it from there. The cartridge concentrates and lyses microbes, purifies the sample and removes any inhibitors, and then pulls the purified genomic material into the system’s microfluidics. The device performs a series of PCR reactions, including internal process controls, amplifies highly multiplex qPCR reactions, and analyzes the results. The system produces a report in approximately one hour that can be delivered to a mobile device, computer, or other tracking system.

Miqlab is designed to detect up to 27 pathogens simultaneously, so it could screen for different strains of the coronavirus or for a mix of coronaviruses and other common respiratory pathogens. Its open access technology makes adding strain-specific assays to the multiplex a straightforward process, but doing so upfront would complicate the process at the FDA.

“The Miqlab is arguably the only system designed to work at the point-of-care where strain identification could be rapidly deployed. This might become particularly important if a strain emerges that is a poor match for the vaccines. Lexagene must first get its technology through the FDA for simply detecting the presence of SARS-CoV-2,” Regan explained. “Only once our Miqlab system and the initial SARS-CoV-2 test is authorized, will we approach the FDA for adding a test for strain identification. If we were to bundle strain identification in during the first submission, it would probably at least double the length of time to get through the FDA, whereas broaching this topic after getting the system cleared, will hopefully lead to a faster time to implementation in the field.”

Currently, the plan is for the Miqlab to be paired with a kit for standard COVID-19 testing that includes 25 sample preparation cartridges and enough assays and buffers to process 25 samples.