LexaGene Holdings Inc (CVE:LXG) (OTCMKTS:LXXGF) said it is adding additional strength to its team as it continues to work towards commercializing its genetic analyzer for pathogen detection.
The Beverly, Massachusetts-based company is bringing on medical device expert Steven Armstrong as senior director of operations, it announced Tuesday.
Armstrong will play a key role in helping the firm prepare its submission to a US Food & Drug Administration (FDA) Emergency Use Authorization of its commercial technology and other regulatory approvals.
“I’m thrilled that Mr Armstrong has joined the team to guide us during this next phase of commercial manufacturing,” LexaGene CEO Jack Regan said in a statement.
“We are taking every measure to hasten our readiness for FDA approval, not only for our commercial analyzer, but also for the test chemistry of our diagnostic panels. Mr. Armstrong has an enormous amount of experience in navigating the regulatory clearance landscape, as well as launching innovative medical devices, and I look forward to the leadership he will provide LexaGene in getting to the commercial finish line faster.”
Throughout his career, Armstrong has overseen the global operations of complex medical devices and obtained FDA and regulatory approvals for over 50 devices in 10 countries. He was directly involved in the development and launch of LASIK technology and has vast experience with laser and light-based technologies.
LexaGene has revealed that it will soon start manufacturing its flagship LX Genetic Analyzer for rapid pathogen detection, with an anticipated commercial launch in 2020.
The firm recently revealed that it is accelerating the submission of its LX Analyzer to the FDA as the coronavirus (COVID-19) outbreak expands.
In response so far, the FDA has encouraged labs and manufacturers to submit applications for Emergency Use Authorization to help address the lack of quality diagnostics to fight this disease.
“The current COVID-19 diagnostic crisis has prevented effective mitigation and treatment measures to date,” CEO Regan told shareholders.
“At LexaGene, we have rapidly turned our attention to this problem and have dedicated resources towards setting up a quality system that is required for FDA diagnostic devices and pushing forward manufacturing as quickly as possible. Laying this groundwork is necessary so that we can contribute to solving this crisis by providing a solution for rapid point-of-need diagnostics that can easily be configured for new tests as needed.”
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