Concept: California’s healthcare diagnostics startup Fluxergy has developed a one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. Medical professionals can use the startup’s lab-on-a-chip consumable test cartridge to diagnose patients with COVID-19 at point-of-care. The test kit received Conformité Européenne (CE) mark to commercially market it in the European Union.
Nature of Disruption: The Fluxergy testing device comprises an analyzer that performs the testing, a Fluxergy Card, which is a single-used, lab-on-a-chip test cartridge, and Fluxergy Works software to review and interpret the test data. The fully automated diagnostic testing system needs only a nasal swab for testing. This is combined with a reagent, loaded onto a Fluxergy card and inserted into the Fluxergy analyzer. Positive detection of target nucleic acid is confirmed by the accumulation of a fluorescent signal after the specific target DNA is amplified. This is confirmed by sensors that look for the presence of the target gene (COVID-19) and an internal control target.
Outlook: The worldwide scarcity and inaccessibility to COVID-19 testing have hampered efforts to combat the pandemic in the US and around the world. Rapid point-of-care diagnostics PCR tests for COVID-19, such as the Fluxergy, can save considerable time and deliver quick results to take preventive actions. The startup is currently determining beneficial partnerships to provide the product to APAC, Europe and the Middle Eastern markets where the CE mark is accepted. Fluxergy has raised $30mn in venture funding to scale the production of its testing kits in response to the COVID-19 pandemic. Moreover, it has filed a request for emergency use authorization of its lab-on-a-chip testing device from the USFDA.