Beverly, Mass.-based Lexagene Holdings Inc. has developed a genetic analyzer with multiplex testing capability that would enable it to determine whether a patient has COVID-19, influenza or another respiratory infection with one sample. The Lx Analyzer uses a proprietary quantitative reverse transcription polymerase chain reaction (RT-qPCR) method to automatically test for up to 27 pathogens simultaneously, all in about one hour.

The company has submitted an application for an emergency use authorization and hopes to sell its first instrument in September, Lexagene co-founder and CEO Jack Regan told BioWorld.

The approximately 13” x 17” x 20” device could be used at the point of care. The analyzer minimizes the burden for testers and requires no training. Testers load a sample and a cartridge into the analyzer, and press “go.” The device can process two samples at a time.

“It’s very simple,” said Regan. “The analyzer automatically performs one to nine reactions. Each reaction can do four different tests, one for an internal positive control and the other three for targets of interest.”

The system uses microfluidics to pull reagents from bulk reservoirs in the device. That design minimizes the use of reagents and the reduces the cost of cartridges.

The device offers quick turnaround that could facilitate the increase in testing and contact tracing advocated by the NIH and CDC.

With analyzers placed in communities, “a contact tracer can take a sample, place it in an instrument within half an hour and get results within two hours” of taking a swab, Regan said. Knowing quickly who is positive for SARS-CoV-2 would allow tracers to go back to the contact right away, before they spread the disease to more people.

Managing the next wave and the next pathogen

“Right now, we’re focused only on COVID-19 testing [as a country]. That’s appropriate because other influenza-like illnesses are rare in summertime,” Regan noted. “However, that changes in the fall and winter.”

Being able to evaluate a sample for up to 27 different targets at once both facilitates disease tracking and eliminates the mystery of a negative result. “Is it a false negative? Is it parainfluenza or RSV? We don’t know,” he added.

Testing patients in respiratory distress for a range of common respiratory viruses could identify that the patient had adenovirus, instead. That positive identification would reassure both the physician and patient that they were looking at a few days of congestion and fatigue rather than potential hospitalization.

“The analyzer’s multiplex testing capability is an important part of future testing needs, especially if the anticipated second wave of COVID-19 testing in the fall occurs with the added burden of a new flu season. The Lx Analyzer is capable of testing for COVID-19, as well as flu and other common respiratory pathogens such as adenovirus and RSV at the point-of-need in clinics, hospitals, or elsewhere in the field,” said Regan. “Hospitals have told us what they need, and we are working with partners on the research of this deadly virus with the hope of being the testing provider they choose.”

The company has a precommercial unit of its Lx Analyzer at a major U.S. hospital laboratory for testing COVID-19.

The utility is clear in an emerging pandemic. Multiplex testing for COVID-19, had it been available, as well as influenza might have detected the spread of the novel coronavirus across the U.S. earlier this year.

The CDC’s weekly flu reports show an increase in visits for influenza-like illnesses from the end of February to late March, even though the number of positive influenza tests dropped continuously from the end of January. Deaths from pneumonia and influenza also spiked during that period.

The pandemic illustrates “what we need to understand. If people are coming in for a test, and we don’t know why they are sick, especially if they start dying, we need to know whether a new test is needed or a new virus has emerged,” Regan explained. “In the absence of syndromic testing, we simply can’t tell.”

The open-access feature of the Lx Genetic Analyzer allows users to run their own assays for customized testing or to use Lexagene’s range of validated assays. Its plug-and-play capability enables rapid reconfiguration to detect novel pathogens, Regan noted.

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