OTS - Fluxergy, Inc. Receives CE-IVD Marking for a One-Hour COVID-19 RT-PCR Test and Positions for European Market Entry
2021. April 12. 09:00
Irvine, CA., 12 April, 2021 (APA/OTS) - 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.
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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.
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