Fluxergy Submits Request for FDA Emergency Use Authorization (EUA) for One-Hour COVID-19 Test at POC

IRVINE, CA., March 30, 2020 – Fluxergy, a research and medical diagnostic test company based in Irvine California, has submitted an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) Center For Devices and Radiological Health, seeking an authorization that would permit medical professionals to begin using the company’s high-speed Research Use Only (RUO) test system as a COVID-19 diagnostic at the point-of-care (POC).

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 tests performed by the company and in follow-up validation tests with patient samples completed this week by researchers at University of California San Diego (UC San Diego). The UC San Diego physician-scientist research team that conducted the validation, completed on March 27, 2020, has been led by Dr. Davey Smith, Professor of Medicine and Head of the UCSD Division of Infectious Diseases and Global Public Health. Dr. Smith is a member of the Fluxergy Medical Advisory Board.

Advanced rapid point-of-care PCR tests for COVID-19 like the Fluxergy Analyzer system may have the potential to save significant time compared to standard lab tests that must be shipped to centralized laboratories for processing. Fluxergy’s on-site sample-to-answer test for COVID-19 requires a very small sample, typically a nasal swab. This swab is mixed with a reagent solution, loaded onto the Fluxergy card and inserted into the Fluxergy Analyzer in a convenient two-step procedure.

“The worldwide shortage and inaccessibility of COVID-19 tests have been major impediments to containing the pandemic in the U.S. and globally,” said Dr. Ali Tinazli, Chief Commercial Officer at Fluxergy. “We are gratified to be progressing toward the next important milestone in the development of our point-of-care diagnostic technology.”

About Fluxergy

Fluxergy, launched in 2013 with funding support of investor John Tu, co-founder of Kingston Technologies, seeks to provide a portable, highly sophisticated and 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). Fluxergy’s solution is a portable testing platform based on three core elements: the single-use consumable Fluxergy Card, the Fluxergy Analyzer, and its user interface Fluxergy Works. The Fluxergy Analyzer and the single-use consumable Fluxergy Cards (lab-on-chip) are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. Leveraging Fluxergy Works Software, as many as 256 Fluxergy Analyzers can be managed with one local server and linked to the Cloud to provide powerful access to help manage patient data. Please visit fluxergy.com for more information.

BUSINESS CONTACT: Dr. Ali Tinazli, +1 (310) 467-1112, atinazli@fluxergy.com

EUROPE AND AFRICA CONTACT: Dr. Randolph Seidler, +49 (151) 52255787, rseidler@fluxergy.com

 

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*Only Fluxergy Test Kit COVID-19 has been approved for CE-IVD and is available for any markets that accept CE marking as the valid regulatory approval.

All other products or any other markets are For Research Use Only (RUO) and are not for use in diagnostic procedures.

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