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

IRVINE, CA. – News Aktuell – 12 April
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.

The Fluxergy Diagnostic System: The Fluxergy Analyzer, which conducts the testing; the Fluxergy Card, a single-use test cartridge and its reagents; and the FluxergyWorks software, to manage the test data. The Fluxergy Test Kit COVID-19 is only available for purchase in the European Union market and any other markets that accept the CE-marking as valid regulatory approval. COURTESY: FLUXERGY, INC.

 

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 in the European Union
market and any other markets that accept the CE-marking as valid regulatory
approval.