New leadership brings experience achieving FDA clearance and launching products
BEVERLY, Mass., March 24, 2020 (GLOBE NEWSWIRE) -- LexaGene Holdings, Inc., (OTCQB: LXXGF; TSX-V: LXG) (the “Company”), a biotechnology company that develops genetic analyzers for rapid pathogen detection and other molecular markers, today announced the appointment of Mr. Steven Armstrong to the role of Senior Director of Operations to oversee the Company’s submission for FDA Emergency Use Authorization of its commercial technology and other regulatory approvals, as well as to institute quality systems for manufacturing.
Dr. Jack Regan, LexaGene’s CEO and Founder states, “I’m thrilled that Mr. Armstrong has joined the team to guide us during this next phase of commercial manufacturing. 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.”
Mr. Armstrong has spent his career leading numerous teams in the commercialization of complex medical devices, directly overseeing global operations including design, development, manufacturing and service operations in eight countries. Throughout his career he has been responsible for obtaining FDA and global regulatory approvals in over 100 countries, for more than fifty devices with hundreds of indications, implementing best-in-class quality managements systems, and ensuring worldwide compliance. Mr. Armstrong started his career involved with the development and launch of LASIK technology and has brought new laser and light-based technologies to a variety of medical specialties over the past twenty-five years for organizations including Palomar Medical Technologies until its sale in 2013 for approximately USD $300M and IPG Medical in both clinical and veterinary technologies.
Dr. Regan continues, “The current COVID-19 diagnostic crisis has prevented effective mitigation and treatment measures to date. 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.”
About LexaGene Holdings Inc.
LexaGene is a biotechnology company that develops genetic analyzers for pathogen detection and 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 LX Analyzer delivers excellent sensitivity, specificity, and breadth of detection and can return results in about 1 hour. 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.
Director of Corporate Marketing, LexaGene
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Vice President of Capital Markets, LexaGene
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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.