Fluxergy Expands Research and Manufacturing Facility in California
Fluxergy's Irvine campus will encompass over 65,000 sq. ft, as the company seeks to quickly build capacity for producing a high-speed point of care diagnostic testing system to assist in the COVID-19 pandemic response.
July 21, 2020, Irvine, CA -- Fluxergy LLC, has entered into an agreement to establish a new and expanded research and manufacturing center near the Irvine Spectrum to support increased production of its medical diagnostic testing system, which is being developed for point-of-care applications. The new facility, located at 15 Musick, sits across from Fluxergy's current offices in Irvine, CA, and will encompass more than 20,000 square feet of production space, increasing the company's Irvine presence to over 65,000 sq. ft.
"I'm very excited about this significant expansion in our production capability," said Ryan Revilla, Fluxergy Co-Founder and Vice President. "We expect our new facility will enable us to significantly scale our current automated production process, provide space for expanding our multimodal testing capabilities, and ultimately allow us to provide cost-effective, accessible testing to a much larger audience." Fluxergy plans to leverage its expanded capability to partner with innovative companies across multiple industries that want to become early adopters of Fluxergy's rapid multifunction testing platform. Fluxergy is encouraging interested companies to reach out to discuss how they might work together.
The new building in Irvine is a major investment in the growth of Fluxergy, and will support the company's desire to continue to produce all of the primary facets of its innovative diagnostic testing system, including the Fluxergy Analyzer, Fluxergy Test Card, and the supporting reagents, entirely within the United States.
Currently, Fluxergy products are offered for Research Use Only. However, Revilla said that a significant portion of the new production capability will initially be devoted to manufacturing the company's COVID-19 test, for which the Company has filed a request for Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The company's COVID-19 test has been shown in initial studies to identify the SARS-CoV-2 virus, which causes COVID-19, in under one hour. If the EUA is granted, medical sites with CLIA-certified high complexity laboratories would be permitted to use the Fluxergy system as a COVID-19 diagnostic tool in accordance with the FDA's authorization.
Fluxergy announced in May that it received $30 million in capital from its principal investor John Tu, a co-founder of Kingston Technologies, to support the ramp-up of the company's manufacturing capacity. When fully operational, the new manufacturing site is designed to produce up to one million COVID-19 test kits per month.
"Experts have estimated we will need more than 10 million COVID-19 tests per day as a nation to safely reopen," said Dr. Ali Tinazli, Fluxergy' Chief Commercial Officer. "Our goal is to deliver an innovative and high-speed testing solution that can eventually be delivered at the point-of-care, and can help support the growing testing need as the nation continues to battle the COVID-19 pandemic."
Fluxergy launched in 2013 with funding support from principal investor and Kingston Technology co-founder John Tu. The Fluxergy system uses patented microfluidics and a highly integrated sensor system to produce a more flexible and cost-effective testing platform. The Fluxergy Diagnostic Testing System consists of The Fluxergy Card, a single-use "lab-on-chip" consumable test cartridge; the Fluxergy Analyzer, which conducts the testing process, and FluxergyWorks, software used to review and interpret the test data. The Fluxergy Cards are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. FluxergyWorks enables organizations to link together via the Cloud as many as 256 Fluxergy Analyzers for centralized data reporting.
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*Fluxergy's products are for Research Use Only (RUO) and are not for use in diagnostic procedures. Fluxergy's products are not yet cleared by the FDA or USDA for in vitro diagnostic use. None of these statements have been endorsed by the FDA or USDA. Fluxergy does not currently sell products for human or animal use. Although forward-looking statements contained in this document regarding Fluxergy's objectives, plans, goals, strategies, future growth, business prospects and opportunities are based upon what Fluxergy management believes are reasonable assumptions, estimates, and other judgments, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
Dr. Ali Tinazli, Chief Commercial Officer