Irvine, California-based Fluxergy LLC, a diagnostic test company, is making a $30 million investment to expand its capability to scale production of the Fluxergy Analyzer diagnostic testing system in response to the COVID-19 pandemic.
The Fluxergy system, utilizing state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in one hour in studies conducted by the company, and by physician-scientists at the University of California San Diego. Fluxergy has started additional validation studies at world-leading health systems and plans to continue making its testing platform available as a Research Use Only (RUO) system for suitable partners during the current public health emergency.
“We anticipate that our significant investment to step up our manufacturing capability will enable Fluxergy to deliver as many as one million tests per month by the end of 2020, reflecting our confidence in our technology as an innovative solution to COVID-19 testing shortages,” said Dr. Ali Tinazli, Chief Commercial Officer of Fluxergy.
Fluxergy recently filed a request for an Emergency Use Authorization (EUA) with the U.S. Food and Drug Administration (FDA) to permit medical sites with CLIA-certified high complexity laboratories to begin using the company’s high-speed test system for COVID-19 in accordance with the scope of FDA’s authorization.
Fluxergy, launched in 2013 with funding support of principal investor and Kingston Technology co-founder John Tu, seeks to provide a portable, easy to use sample-to-answer POC platform that enables clinicians to cost-effectively conduct a wide range of multiplex and multimodal in vitro diagnostic tests (different types of tests all at once, up to 30 targets). Visit fluxergy.com for more information.