NEW YORK – From its beginning as a diagnostic company with a focus on veterinary medicine, LexaGene has taken the path of many other firms since the pandemic began – transitioning technology and resources to detecting COVID-19 in humans.
With its MiQLab sample-to-answer RT-PCR system, the firm is seeking to differentiate itself from competitors with a platform that facilitates the use of customizable syndromic panels that can look for 27 targets.
According to LexaGene CEO Jack Regan, the MiQLab is fully automated and can be adapted to different communities and demands during the coronavirus pandemic.
"Most companies … fully control every aspect of the solution," Regan said. But LexaGene split up the single-use cartridge from the chemistry, allowing the chemistry to be quickly configured to whichever test is needed and helping users get around manufacturing bottlenecks, Regan said. If they want, users can add their own assays to the vials that go into LexaGene's cartridges and broaden their targets to search for whatever they want.
"The end user has flexibility and the freedom to modify the system to detect what they're interested in," Regan said. The open-access nature of the platform makes it easily modifiable and LexaGene sells its own validating components for the system, but end users have the option to customize if they choose, he added.
The firm used the primers and probes from the US Centers for Disease Control and Prevention to develop its SARS-CoV-2 assay, which uses nasopharyngeal swabs that are placed in a vial with transport media and requires a transfer bulb pipette to move the fluid from the vial to LexaGene's cartridge. The sample is lysed in a chamber of the cartridge and then transferred to another chamber where a silica membrane is used to purify the sample. The cartridge is then slid into LexaGene's analyzer where the reagents and flow-through thermocycler are located for amplification and analysis.
The only real hands-on requirement for a user is the pipetting. "It's as user-friendly as you can imagine," Regan said. "If you can collect a sample and do a bulb transfer pipette, you can run the instrument."
Results are returned in under two hours, a slightly longer turnaround time than other point-of-care PCR tests, such as Cepheid's GeneXpert, which returns results in less than an hour, but its capability to look for 27 different targets makes it unique, Regan said. "We're higher than we want to be" in terms of the time to result, "but we're in the ballpark," he added.
Depending on the menu of tests that LexaGene develops for the MiQLab, the system could eventually compete against systems from Becton Dickinson, OpGen, and Qiagen. Other firms offering syndromic panels include Meridian Bioscience, T2 Biosystems, and Quidel.
Nathan Ledeboer, the medical director of the clinical microbiology and molecular diagnostics laboratories at the Medical College of Wisconsin, said LexaGene's instrument would also likely compete with BioFire FirmArray, since they both have tests that are CLIA-waivable as well as tests that are considered CLIA moderate, and the sample prep, instrument size, and turnaround time are comparable.
In terms of customizable syndromic panels, Thermo Fisher Scientific offers its real-time PCR OpenArray technology, which the company said has a full range of solutions to "address its customers' entire workflow from sample to answer with partial automation."
Ledeboer noted that "including an open channel on a syndromic panel test would be pretty complicated as you would need to ensure the new target that the lab added did not alter performance of the other targets." He added that "While some labs may find this useful, I would guess that the vast majority of labs would not be likely to use the open channel due to the challenges in developing an additional target and the necessary regulatory steps that would be required."
In developing its SARS-CoV-2 capabilities, LexaGene picked the CDC components because they've already been vetted by the US Food and Drug Administration, Regan said. It is planning to submit its platform and SARS-CoV-2 test to the FDA for Emergency Use Authorization, then add tests for influenza or respiratory syncytial virus once it has received EUA.
The choice is strategic, Regan said, because it will be easier to get through the FDA with just the coronavirus test, since the company is also submitting its full platform with this application. Once the platform is cleared, Lexagene can expand its chemistry offerings and submit only those to the agency, lessening its hurdles.
The company also intends to sell a collection kit with its platform and SARS-CoV-2 test, Regan said.
One of the future capabilities LexaGene is examining would indicate the specific strain of SARS-CoV-2, in addition to detecting the presence of the virus itself, Regan said. As concern over the transmissibility of new variants of SARS-CoV-2 continues to mount, Regan said he's seen many people say the solution is to modify the vaccine, which could take months. But he thinks the better solution is to develop faster diagnostics that can detect those variants and take other steps to stop the spread.
Currently, LexaGene is designing assays against the genomic fingerprints of the SARS-CoV-2 mutations and verifying their work with the MiQLab, Regan said. The firm announced earlier this month that it has verified the MiQLab can detect mutations associated with the UK and South African variants and has developed tests to detect those variants.
Regan added that the COVID-19 test Lexagene is submitting to the FDA targets "a very conserved region of the SARS-CoV-2 genome" and is designed to pick up all SARS-CoV-2, but not to identify strains. However, he said if the FDA was interested in the platform doing strain identification, it would be easy to add, since the COVID-19 test currently only uses two of the 27 test slots it has.
The initial system it is submitting to the FDA will be "locked" for the COVID-19 application only, but once the firm has received EUA it will "propose to the FDA a manner by which we think we can unlock the software to allow for end-user medication in the event of the need for rapid configuration to detect a new threat," Regan said. This will be called "activating the pandemic mode of the instrument," he added, and the company will work with the FDA to "make sure they are comfortable with how we do this."
MiQLabs used in non-clinical settings won't be locked and can be used as people see fit, but would be classified as research-use-only instruments, he said.
Once the firm has its application for EUA ready, Regan said it will also submit the system to Health Canada for possible initial clearance there. There's a need for SARS-CoV-2 testing globally, but right now the company is focused on North America, although it does expect to eventually aim for CE marking as well.
LexaGene isn't publishing its data until its EUA application is finished, which will likely be in April, but Regan said the platform returns results that are 98 percent concordant with reference laboratory data.
Ledeboer said the system and its 27 targets would be best suited for mid-sized syndromic panels, such as a respiratory panel, a SARS-CoV-2 genotyping panel, or any other syndromic panel. He added that adoption of the technology at the point of care would be dependent on cost of instrumentation, panel cost, and the needs of a practice and said he sees it more commonly being used in a central or clinical laboratory.
The MiQLab is not limited to SARS-CoV-2 testing, Regan emphasized. The platform's "real value proposition" is syndromic testing with multiple targets at once to determine what is causing an illness, he said. LexaGene has already developed a panel for urinary tract infections and has plans to develop panels for gastrointestinal infections, he said.
More importantly, the platform can be used for antibiotic resistance testing, which Regan says has fallen by the wayside during the pandemic. "Superbugs are on the rise, and people were concerned about superbugs before coronavirus hit, but then coronavirus hit and people forgot about superbugs, but they're actually still out here causing a lot of problems and actually getting worse," he said, and the MiQLab can identify the pathogens causing infections or illnesses.
Users can order their own tests from any vendor, formulate them to the right concentration, and put them into the cartridge's vials, making the test they need. This allows users to avoid manufacturing bottlenecks, since they're not limited to purchasing components and tests from one manufacturer, Regan said.
LexaGene sold its first system in the non-veterinary market in December and is working on manufacturing up to 10 systems per week at its facility, Regan said. Once demand increases, he said the firm would contract out the manufacturing.
Last year, the company said it would launch a multiplex viral diagnostic assay for SARS-CoV-2 by the third quarter of 2020, but that didn't come to pass. The original precursors of the MiQLab were its LX6 and LX2 analyzers, and when asked why it took the firm so long to get to this point, Regan emphasized the company's small size of about 37 employees. "We would've loved to be on the market a year ago," Regan said. "We are where we are, and so our job is to try to convince the industry that the technology is needed."
The cost for the platform varies, Regan said, from $25,000 for use in the vet space to around $40,000 for contract drug manufacturing organizations, and the cost per test is between $40 and $120 depending on how many targets are being looked for. "Each industry has a different anticipated average selling price based … on cost sensitivity," Regan said. While the instrument is the same, the tests run are different, with different pathogen targets. Some of the sample matrices may have different sample preparation protocols completed by the MiQLab, he said.
Regan noted that LexaGene plans to make the system smaller, cheaper, and faster through value engineering. But, he said, the goal as a small company was to get it onto the market as fast as possible.
As the SARS-CoV-2 variants continue to spread and the vaccine rollout faces challenges, Regan emphasized the need for more kinds of testing than the US currently has.
"People don't like to admit the fact that we've failed, but we are failing – this virus is winning, and until we revamp and improve our diagnostics to allow for open-access, point-of-care testing … we're going to continue to fail," he continued. The pandemic is far from over, Regan noted, and said there's a need for "better testing technology" in the field to avoid another pandemic in the future. "There's a lot of threats that are out there and there's a lot of room for improving our detection capabilities," he said.