Fluxergy announces $30M to expand manufacturing capacity of diagnostic testing system
Fluxergy plans to continue making its testing platform available as a Research Use Only system during COVID-19
IRVINE, Calif. – 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 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 started additional validation studies at various health systems and plans to continue making its testing platform available as a Research Use Only (RUO) system for partners during COVID-19.
“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 Ali Tinazli, chief commercial officer of Fluxergy, in a prepared statement.
Fluxergy 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.