Irvine, California-based Fluxergy, a diagnostic test company, is making a $30 million investment to rapidly expand its capability to scale production of the Fluxergy Analyzer diagnostic testing system in response to the COVID-19 pandemic.
The Fluxergy Analyzer system, which utilizes state-of-the-art PCR and microfluidics technology, has been shown to accurately identify the SARS-CoV-2 virus in under one hour in bench lab validation studies conducted by the company, and with patient samples by physician-scientists at the University of California San Diego. Fluxergy also announced that it has started additional validation studies at other world health systems and plans to continue making its innovative 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, and reflects our confidence in our technology as an important and innovative solution in expanding COVID-19 testing capability,” 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) Center For Devices and Radiological Health, which, if granted, would permit medical sites with CLIA-certified high complexity laboratories to begin using the company’s high-speed test system as a COVID-19 diagnostic tool in accordance with the scope of FDA’s authorization.
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