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’s innovative testing platform to enter the European Union market and any other markets that accept CE-marking as valid regulatory approval.

Fluxergy’s platform is an automated, sample-to-answer testing platform with multimodal capability allowing for a variety of assay types, such as molecular, immunochemistry, chemistry, and cytometry assays, to be run simultaneously on the same cartridge. This will give users the ability to run unique Point-of-Care (PoC) panels with the potential ability to do built-in reflex testing, among other capabilities. Potential environments for rapid testing applications include emergency rooms, outpatient procedures, urgent care, workplace screening, mobile testing, community level testing settings, school reopenings, and in tourism.

Fluxergy has made its platform available as a Research Use Only (RUO) system for its partners, including University of California San Diego (San Diego, CA, USA) and Mass General Brigham (Boston, MA, USA), during the current public health emergency. In December 2020, Fluxergy received dual ISO-13485:2016 and MDSAP certifications.

Last year, Fluxergy received a $30 million investment from John Tu, principal investor and Kingston Technology co-founder, to rapidly expand its capability to scale production of the Fluxergy Analyzer diagnostic testing system in response to the COVID-19 pandemic. Fluxergy has now expanded manufacturing capabilities for its testing system to up to one million per month.

“Fluxergy is seeking commercial partnerships with healthcare providers and potential international go-to-market partners in Europe, Asia, and Australia”, states Fluxergy’s Chief Commercial Officer, Dr. Ali Tinazli, responsible for global sales.

Fluxergy’s potential for multimodality of its platform raises important and timely questions: How will decentralized testing at the point-of-need become a key enabler for telemedicine? What platforms, technologies, and workflows do we need to be better prepared for the next pandemic? To what extent does telemedicine with the appropriate diagnostic data open up new healthcare opportunities such as in preventive medicine?

For media inquiries, contact Richard Laermer at fluxergy@RLMpr.com

For business inquiries, contact Dr. Ali Tinazli,  atinazli@fluxergy.com

About Fluxergy

Fluxergy, Inc. launched in 2013 with funding support from principal investor and Kingston Technology co-founder John Tu. The Fluxergy system uses patented microfluidics and a highly integrated sensor system to produce a more flexible and cost-effective multimodal testing platform.

The Fluxergy Diagnostic Testing System consists of The Fluxergy Card, a single-use “lab-on-chip” consumable test cartridge; the Fluxergy Analyzer, which conducts the testing process, and Fluxergy Works software is used to review and interpret the test data. The Fluxergy Cards are multi-modal (meaning different types of diagnostic tests can be run simultaneously) and designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. Fluxergy Works enables organizations to link together via the Cloud as many as 256 Fluxergy Analyzers for centralized data reporting. The Fluxergy CoVID-19 Sample-to-Answer-RT-PCR Test is only available for purchase in the European Union market and any other markets that accept the CE-marking as valid regulatory approval.


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Fluxergy Corporate Campus

US Headquarters
30 Fairbanks, Irvine, CA 92618
+1(949) 305-4201

R&D Center
13766 Alton Pkwy, Irvine, CA 92618

Manufacturing Center
15 Musick, Irvine, CA 92618

Fluxergy Europe GmbH i.G.
Eichenstr. 4  63667 Nidda, Germany
+49 6043 403518

*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.

*This website is governed by applicable U.S. laws and governmental regulations. The products and information contained herewith may not be accessible in all countries, and Fluxergy takes no responsibility for such information which may not comply with local country legal process, regulation, registration and usage.

*Although forward-looking statements contained in this website regarding Fluxergy’s objectives, plans, goals, strategies, future growth, business prospects and opportunities are based upon what Fluxergy management believes are reasonable assumptions, estimates, and other judgments, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.

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