GenomeWeb: Fluxergy Nabs CE-IVD Mark for SARS-CoV-2 POC PCR Test

The Irvine, California-based company’s automated, sample-to-answer Fluxergy Diagnostic Testing System has the ability to run multiple different assay types.
Fluxergy, Inc. Receives CE-IVD Marking for a One-Hour COVID-19 RT-PCR Test and Positions for European Market Entry

IRVINE, CA., March 25, 2021 – Fluxergy, Inc., a medical diagnostic testing platform company with a detection technology solution capable of multimodality, announced today that it has obtained CE marking for its one-hour COVID-19 RT-PCR test, to use by healthcare professionals as an in vitro diagnostic (IVD) for the detection of SARS-CoV-2. The CE-mark will allow […]
Fluxergy Featured in SOLIDWORKS 3DEXPERIENCE World 2021

Join President Tej Patel speak at SOLIDWORK’S 3DEXPERIENCE World 2021. Tej shares how Fluxergy leverages SOLIDWORKS to innovate in unprecedented times.
360 DX: Fluxergy Aiming to Provide Low-Cost, Multimodal Testing for SARS-CoV-2, Other Disease Targets

The COVID-19 pandemic has shed light on the need for mass testing, particularly in areas that don’t have access to centralized laboratories or trained technicians.
Fluxergy Expands Research and Manufacturing Facility in Irvine, CA

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 20, 2020, Irvine, CA — Fluxergy LLC, has entered into an agreement to establish a new and expanded research and manufacturing […]
Fluxergy to Collaborate with Mass General Brigham to Conduct Evaluation of One-Hour COVID-19 Test

IRVINE, CA., July 2, 2020 – California-based Fluxergy will work with Mass General Brigham (MGB), a major health system in Massachusetts, to further evaluate Fluxergy’s innovative Research Use Only (RUO) COVID-19 testing platform, designed to deliver accurate PCR test results in under one hour.
Fluxergy, Mass General Brigham Partner to Evaluate Rapid COVID-19 Molecular Testing System

“Fluxergy is proud to work with Mass General Brigham, one of the nation’s most respected healthcare systems, to assist in evaluating the efficacy of the Fluxergy COVID-19 PCR test,” said Dr. Ali Tinazli, Fluxergy’s Chief Commercialization Officer.
John Tu Helped Build OC’s Largest Private Company. Now He’s Funding a Device Maker to Fight the Spread of COVID-19.

John Tu is coming off a standout year at computer memory company Kingston Technology Corp., with record-breaking sales pushing the Fountain Valley maker of flash memory products, gaming equipment and other computer-related memory products to the top spot among Orange County’s largest private companies.
Fluxergy Announces $30 Million to Expand Manufacturing Capacity of its One-Hour Diagnostic System

Fluxergy’s Co-Founder & President Tej Patel (left) and Investor & Co-Founder of Kingston Technologies, John Tu (right) with the Fluxergy Analyzer and Test Card. IRVINE, CA, May 13, 2020 — 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 […]
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 […]
Fox News: UC San Diego scientists and doctors evaluating 1-hour coronavirus test

The test could potentially remove the need to send samples to centralized labs, according to the test’s developer, significantly speeding up a process that can take up to three days to deliver a result.
Researchers At UC San Diego Evaluating Potential “One-Hour” COVID-19 Diagnostic Test Developed By Irvine-Based Innovator Fluxergy

IRVINE, Calif., March 17, 2020 — Physician-scientists at the University of California, San Diego (UCSD) are the first to evaluate a new diagnostic testing system designed by Irvine, CA-based Fluxergy, that holds promise for identifying the SARS-CoV-2 virus (also known as the novel coronavirus) in as little as 45 minutes and typically within one hour. […]