Fluxergy, Inc. Receives CE-IVD Marking for a One-Hour COVID-19 RT-PCR Test and Positions for European Market Entry

IRVINE, CA., April 12, 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 and community level testing settings.
Fluxergy has made its platform available as 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 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 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 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 diagnostic data unlock new healthcare opportunities such as in preventive medicine?
For more information, contact Richard Laermer (+1-212-741-5106 X216; fluxergy@RLMpr.com) and visit www.fluxergy.com.
Disclaimer
The Fluxergy Test Kit COVID-19 is only available for purchase inthe European Union market and any other markets that accept the CE-marking as valid regulatory approval.
Images
About news aktuell GmbH
news aktuell, a subsidiary of the Deutsche Presse-Agentur (dpa), provides companies, institutions and associations with effective access to both the media and consumers and supports the organizations in telling their stories easily and successfully. Utilizing the digital tools “ots” and “zimpel” PR content reaches all media formats, including classic print titles, wide-reach online portals or social networks. In addition, news aktuell publishes all of its clients' PR content on www.presseportal.de, one of Germany's widest-reaching PR portals. Thus, all relevant multipliers are reached worldwide, ranging from editors and digital influencers to specialist bloggers and interested consumers. Communications specialists from all over Germany rely on the expertise of the dpa subsidiary. news aktuell has been on the market since 1989 and employs over 135 people. The company is based in Hamburg. Further locations include Berlin, Frankfurt and Munich.
Subscribe to releases from news aktuell GmbH
Subscribe to all the latest releases from news aktuell GmbH by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from news aktuell GmbH
FEV Group: Generative AI accelerates homologation: FEV simplifies country-specific type approval processes10.7.2025 11:23:00 CEST | Press release
Aachen – Vehicle development doesn’t end with technical readiness: The road to global market launches is only complete once homologation has been successfully achieved. The increasing complexity of national regulations poses growing challenges to OEMs and suppliers. FEV addresses these with an innovative, AI-based approach: The company-wide used ‘FEV GenAI Hub’ significantly simplifies and accelerates the analysis of regulatory requirements across different global markets, offering time and cost savings that can provide customers with a decisive competitive edge.
Green: Innovation from Switzerland: New pump drive developed by Green’s Andrea Luigi Campomilla providing more efficiency in data center cooling8.7.2025 09:38:05 CEST | Press release
Andrea Luigi Campomilla, Green’s Chief Operating Officer and Chief Engineer, is commissioning a newly developed pump drive. The results are promising.
Intuitive Surgical Deutschland GmbH: Intuitive’s da Vinci 5 Surgical System Receives CE Mark2.7.2025 09:55:29 CEST | Press release
Fifth-generation da Vinci surgical system approved for use in Europe across multiple procedures
EUROJET signs contract to provide EJ200 Engines for the recent Italian Air Force Eurofighter Order of up to 24 Aircraft27.6.2025 16:25:57 CEST | Press release
Rome, Italy, Friday, 27th June 2025 EUROJET Turbo GmbH, the consortium behind the EJ200 engine that powers the Eurofighter Typhoon, has today signed a new contract with the NATO Eurofighter & Tornado Management Agency (NETMA). Under this agreement, EUROJET will deliver up to 54 new EJ200 engines to the Italian Air Force as part of the Eurofighter Tranche I replacement. A renaissance of interest in the programme, it follows hot on the heels of the Spanish Halcón II contract announced at the end of last year.
European Marketing Distribution: MANIELE TASCA TAKES OVER PRESIDENCY OF EUROPE'S LEADING TRADE ALLIANCE EMD27.6.2025 08:30:00 CEST | Press release
Top manager from Italy emphasises continued close partnership with industry Stephanie Lotter, Director at Globus in Germany, elected to the EMD Executive Board
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom