Fluxergy Collaborates with Mass General Brigham to Evaluate One-Hour COVID-19 Diagnostic Test
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By LabMedica International staff writers Posted on 03 Jul 2020 |
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Image: The Fluxergy diagnostic testing system (Photo courtesy of Fluxergy)
Fluxergy (Irvine, CA, USA) will work with Mass General Brigham (MGB Boston, MA, USA) to further evaluate the company’s innovative Research Use Only (RUO) COVID-19 testing platform, designed to deliver accurate PCR test results in under one hour.
Fluxergy has filed a request for an Emergency Use Authorization (EUA) from the US 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.
"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 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.
Related Links:
Fluxergy
Mass General Brigham
Fluxergy has filed a request for an Emergency Use Authorization (EUA) from the US 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.
"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 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.
Related Links:
Fluxergy
Mass General Brigham
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