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AscencioDx COVID-19 test, molecular detector get EUA

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March 2023—Anavasi Diagnostics announced FDA emergency use authorization for its Ascencio­Dx COVID-19 test and AscencioDx molecular detector for use in POC settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation. The system uses reverse transcription loop-mediated isothermal amplification for the qualitative detection of RNA from the COVID-19 virus in samples that are heated and illuminated via fluorescence signals in a reaction tube placed within the detector. Results are available in as few as 20 minutes. The detector is reusable for at least 3,000 test cycles, the company says, and is powered by a 12-volt adapter.

Anavasi Diagnostics, 888-262-8274

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