One-Hour COVID-19 RT-PCR Test Obtains CE Mark
A California-based medical diagnostic testing platform company with a detection technology solution capable of multimodality announced today that it had 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.
Fluxergy, Inc confirmed on March 25, 2021, the CE-mark will enable Fluxergy’s innovative testing platform to enter the European Union market and any other markets that accept CE-marking as valid regulatory approval.
In December 2020, Fluxergy received dual ISO-13485:2016 and MDSAP certifications.
Fluxergy’s innovative platform is an automated, sample-to-answer testing platform with multimodal capability enabling various assay types, such as molecular, immunochemistry, chemistry, and cytometry assays, to be run simultaneously on the same cartridge.
This innovation gives users the ability to run unique Point-of-Care (PoC) panels with the potential ability to do built-in reflex testing, among other capabilities.
Likely environments for rapid testing applications include emergency rooms, outpatient procedures, urgent care, workplace screening, mobile testing, community-level testing settings, school reopenings, pharmacies, and tourism.
Fluxergy has made its platform available as a Research Use Only system for its partners, including the University of California San Diego and Mass General Brigham, during the current public health emergency.
Fluxergy’s potential for multimodality of its platform raises essential and timely questions, such as the following:
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 preventive medicine?
“Fluxergy is seeking commercial partnerships with healthcare providers and potential international go-to-market partners in Europe, Asia, and Australia,” stated Fluxergy’s Chief Commercial Officer, Dr. Ali Tinazli, in a related press release.
In 2020, 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.
In 2020, Fluxergy submitted an Emergency Use Authorization request to the U.S. Food and Drug Administration Center For Devices and Radiological Health.
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.
Fluxergy, Inc. launched in Irvine, CA, 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 diagnostic tests can be run simultaneously) and designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing microfluidics technologies. Fluxergy Works enables organizations to link together via the Cloud as many as 256 Fluxergy Analyzers for centralized data reporting.
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