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Anavasi Diagnostics Receives FDA EUA for AscencioDx Covid-19 Test

Monday, February 13, 2023

According to Anavasi Diagnostics, the FDA has now granted the AscencioDx® COVID-19 Test and The AscencioDx® Molecular Analyzer an Emergency Use Permit (EUA).

The AscencioDx® COVID-19 test yields findings for the detection of SARS-CoV-2 RNA. The AscencioDx system's portability and affordability make it possible to perform high-quality point-of-care molecular testing in a variety of healthcare settings, including facilities like urgent care facilities, mobile testing locations, assisted living facilities, and more.

The AscencioDx® COVID-19 test yields findings for the detection of SARS-CoV-2 RNA in as little as 20 minutes. The AscencioDx system's portability and affordability enables to perform high-quality point-of-care molecular testing in a variety of healthcare environments including facilities like urgent care facilities, mobile testing locations, assisted nursing care facilities, and more.

The test reduces the possibility of missing a novel strain by targeting numerous areas of the viral genome using proprietary assay chemistry. The AscencioDx proprietary platform will also facilitate quick product development for new viral and bacterial targets, such as strains linked to sexual health, RSV, influenza, and more.

Contrary to more expensive and complex PCR testing, the AscencioDx Molecular Detector's proprietary compact design uses RT-LAMP (reverse transcription loop-mediated isothermal amplification) technology and doesn't require sending a sample to a different location or waiting days for results.

The AscencioDx Molecular Detector and COVID-19 Test generate less biowaste because the detector can be used for at least 3,000 test rounds. It doesn't require batteries or other electrical components to be discarded after use, unlike the majority of single-use molecular tests. Compared to other molecular POC tests, the AscencioDx system comes with less packing and disposable parts.

Qualified facilities can instantly access the AscencioDx COVID-19 Test and the AscencioDx Molecular Detector.

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