Policy & Regulation
Fluxergy and MGB collaborate to assess Fluxergy's Research Use Only COVID-19 testing platform
3 July 2020 -

United States-based Fluxergy and Mass General Brigham (MGB), a medical institution, are collaborating to further assess Fluxergy's Research Use Only COVID-19 testing platform, it was reported on Thursday.

The platform is designed to deliver accurate PCR test results in less than one hour.

The United States Food and Drug Administration (FDA) has received a request for an Emergency Use Authorization for the product from Fluxergy. If the product receives approval, the Emergency Use Authorisation is to 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 authorisation. Mass General Brigham is also planning to publish its findings for review by other medical institutions.

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