Ellume’s COVID-19 Home Test Receives the US FDA’s EUA as First Over-the-Counter Diagnostic Test

December 16, 2020 Auto Bot ellume, EUA, MedTech, receives, regulatory, Test, Us FDA 0

Shots:

  • The US FDA has granted EUA for Ellume COVID-19 home test for non-prescription home use in symptomatic and asymptomatic individuals aged ≥2yrs.
  • The data submitted to the US FDA from an independently run, simulated home-setting clinical study of 198 subjects aged 2-82yrs, demonstrated 96% accuracy including 95% overall sensitivity & 97% specificity vs emergency use-authorized RT-PCR lab test
  • The test’s core technology combines ultra-sensitive optics, electronic software to leverage digital immunoassay technology with next-generation multi-quantum dot fluorescence technology

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: MobiHealth News

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