Fluxergy to Collaborate with Mass General Brigham to Conduct Evaluation of One-Hour COVID-19 Test
IRVINE, CA., July 2, 2020 – California-based Fluxergy will work with Mass General Brigham (MGB), a major health system in Massachusetts, to further evaluate Fluxergy’s innovative Research Use Only (RUO) COVID-19 testing platform, designed to deliver accurate PCR test results in under one hour.
“MGB is committed to working collaboratively with innovators in the medical field like Fluxergy to help assess new technologies that may enable our hospitals and other medical institutions to more quickly and accurately identify patients with COVID-19, and keep medical staff safely on the job,” said Lauren Ritterhouse, MD, PhD, Associate Director for the Center for Integrated Diagnostics in the Department of Pathology at Massachusetts General Hospital, and Assistant Professor at Harvard Medical School.
Fluxergy has filed a request for an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). If granted, the EUA would permit medical sites with CLIA-certified high complexity laboratories, such as MGB, to use the Fluxergy system as a COVID-19 diagnostic tool in accordance with the FDA’s authorization. Subject to confirming the performance of the Fluxergy system, and the potential receipt by Fluxergy of the EUA, MGB may utilize the new platform within its healthcare system. MGB also has plans to publish its findings for review by other medical institutions.
Fluxergy is also working to develop additional validation data that may support a possible future EUA request to use its COVID-19 testing system at the point-of-care, such as at physician offices, urgent care centers, and outreach clinics. Fluxergy has also begun initial work developing a first-of-its-kind multimodal test that may be able to perform a combined PCR and immunoassay (antibody) COVID-19 analysis using a single Fluxergy test card.
“Fluxergy is proud to work with Mass General Brigham, one of the nation’s most respected healthcare systems, to assist in evaluating the efficacy of the Fluxergy COVID-19 PCR test,” said Dr. Ali Tinazli, Fluxergy’s Chief Commercialization Officer.
Fluxergy recently announced that it has received $30 million in capital from its principal investor John Tu, a co-founder of Kingston Technologies, to ramp up manufacturing capacity to produce as many as one million COVID-19 tests per month in the U.S. by year end.
Fluxergy LLC, founded in 2013, seeks to provide a portable, easy-to-use sample-to-answer platform that enables clinicians to cost-effectively conduct a wide range of sophisticated multiplex and multimodal in vitro diagnostic tests (different types of tests all at once, up to 30 targets) at the point-of-care.
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; the FluxergyWorks software, used by the clinician/operator to review and interpret the test data. The Fluxergy Cards are designed to be very cost-effective and scalable, using proprietary printed circuit board (PCB) manufacturing and microfluidics technologies. FluxergyWorks enables organizations to link together via the Cloud as many as 256 Fluxergy Analyzers for centralized data reporting.
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