BEVERLY, Mass. USA – October 25, 2021 – LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (“LexaGene” or the “Company”), a molecular diagnostics company that has commercialized an instrument for automated multiplex PCR testing for veterinary diagnostics and biopharmaceutical manufacturing, today announced it has completed its analytical studies required by the FDA for an Emergency Use Authorization (EUA) application for COVID-19 diagnostics.
LexaGene is in the process of completing the necessary work to have the FDA rule on authorizing the MiQLab™ for COVID-19 testing. The 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 is comprised of hardware, firmware, software, and chemistry, for evaluation by the FDA, is considerably more complex than if it were simply submitting only a COVID-19 PCR test chemistry for FDA authorization.
Dr. Jack Regan, LexaGene’s CEO and Founder stated, “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. 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: Limit of Detection (LoD)
- Analytical Specificity: Cross-Reactivity
- Endogenous Interference Substances Studies
- Carry-over/Cross-Contamination Study
- Sample Stability
Dr. Regan continued, “This milestone should be viewed as having much broader implications than COVID-19 testing only. Our goal is to get our technology through the FDA so that we 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. 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. To LexaGene’s 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, there is no guarantee the FDA will deem the data to be satisfactory for authorization of the system for human clinical diagnostics. Prior to the FDA’s ruling, all data and communications with the FDA are deemed private. 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.
An interview with Dr. Regan can be viewed HERE.
On Behalf of the Board of Directors
Dr. Jack Regan
Chief Executive Officer & Chairman
Corporate & Media Contact:
Director of Marketing
About LexaGene Holdings Inc.
LexaGene is a molecular diagnostics company that develops molecular diagnostic systems for pathogen detection and genetic testing for other molecular markers for on-site rapid testing in veterinary diagnostics, food safety and for use in open-access markets such as clinical research, agricultural testing, and biodefense. End-users simply need to collect a sample, load it onto the instrument with a sample preparation cartridge, enter sample ID and press ‘go’. The MiQLab™ system delivers excellent sensitivity, specificity, and breadth of detection and can return results in approximately two hours. The unique open-access feature is designed for custom testing so that end-users can load their own real-time PCR assays onto the instrument to target any genetic target of interest.
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This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Important factors — including the availability of funds, the results of financing efforts, the success of technology development efforts, the cost to procure critical parts, performance of the instrument, market acceptance of the technology, regulatory acceptance, and licensing issues — that could cause actual results to differ materially from the Company’s expectations as disclosed in the Company’s documents filed from time to time on SEDAR (see www.sedar.com). Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.