LexaGene Holdings Inc. (TSX-V:LXG, OTCQB:LXXGF) has completed its analytical studies required by the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) application for coronavirus (COVID-19) diagnostics.
The company said it is in the process of completing the necessary work to have the FDA rule on authorizing the MiQLab for COVID-19 testing.
LexaGene noted that FDA is expected to classify the MiQLab as a class II medical device. As such, the process of preparing its point-of-care (POC) fully-automated PCR system, which comprises hardware, firmware, software, and chemistry for FDA evaluation, is considerably more complex than if it were simply submitting only a COVID-19 PCR test chemistry for authorization.
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“Successfully completing these studies is a big step for LexaGene, as these data could only be collected after we have sufficiently met a number of requirements for system/software verification, electrical safety testing, manufacturing process qualification, quality control, and the associated documentation,” said LexaGene CEO Dr. Jack Regan in a statement.
“It is our belief that the quality of our data will meet FDA expectations. Our next step is to have a third party conduct a COVID-19 clinical evaluation using the MiQLab System at both a POC testing facility and a clinical laboratory, and then the analytical and clinical data will be compiled and submitted to the FDA for authorization.”
The following analytical studies were completed using multiple MiQLab Systems:
- External Quality Control Validation
- Analytical Sensitivity of Limit of Detection (LoD)
- Analytical Specificity of Cross-Reactivity
- Endogenous Interference Substances Studies
- Carry-over/Cross-Contamination Study
- Sample Stability
Dr Regan said the company’s goal is to get its technology through the FDA so that it can leverage the system’s high-quality sample preparation followed by broad-multiplex PCR analysis, which is a combination of features that many currently authorized COVID-19-only testing devices do not have.
“These features make the MiQLab ideally suited for syndromic testing of complex diseases that can be caused by 10 or more pathogens, such as respiratory diseases (e.g., COVID-19, influenza A & B, RSV, adenovirus, metapneumovirus, etc.), gastro-intestinal diseases, urinary tract diseases, and skin and soft tissue diseases,” he said.
“Preparing our technology to be able to successfully collect the analytical COVID-19 data is arguably the hardest step in the EUA process. If we are successful in being authorized for COVID-19 testing, we will follow this work with studies to support 510(k) applications for complex diseases in human clinical medicine.”
LexaGene’s MiQLab system is unique in that it is a flow-through PCR system. The company said that, to its knowledge, the FDA has never received an application for a flow-through PCR system for use in human clinical diagnostics. It is possible the FDA will require additional studies prior to passing final judgement.
Once the required studies are complete, LexaGene said there is no guarantee the FDA will deem the data to be satisfactory for authorization of the system for human clinical diagnostics.
Until the FDA grants LexaGene’s system EUA for COVID-19 testing, all work using LexaGene instruments is classified as Research Use Only and cannot be used for human clinical diagnostics.
Contact the author: patrick@proactiveinvestors.com
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