Fluxergy said on Thursday that it will further evaluate its Research Use Only (RUO) COVID-19 testing platform designed to deliver accurate PCR test results in under one hour in partnership with Mass General Brigham (MGB), a health system in Massachusetts.

Based in California, Fluxergy has filed a request for an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to permit medical sites with CLIA-certified high complexity laboratories to use the Fluxergy system as a COVID-19 diagnostic tool.

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 as well as plans to publish its findings for review by other medical institutions.

Additionally, Fluxergy is developing additional validation data to support a possible future EUA request to use its COVID-19 testing system at the point-of-care, 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 as well as received USD30m in capital from its principal investor John Tu, a co-founder of Kingston Technologies, to ramp up manufacturing capacity to produce 1m COVID-19 tests per month in the US by year end.