NIH/RADx-funded medical technology firm Anavasi Diagnostics has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for The AscencioDx Covid-19 Test and The AscencioDx Molecular Detector.
Anavasi has developed its new test for the identification of SARS-CoV-2 RNA to deliver a result within 20 minutes.
The Covid-19 test deploys assay chemistry to target several locations on the viral genome, thereby minimising the likelihood of missing a new strain.
The AscencioDx system has been designed to facilitate point-of-care molecular testing in different healthcare environments, including facilities such as mobile testing sites, urgent care centres and assisted nursing care centres.
Furthermore, the platform will allow quick product development for new viral and bacterial targets, such as influenza, RSV and sexual health-related strains.
Anavasi Diagnostics president and CEO Nelson Patterson said: “Accurate, quick, and affordable molecular testing remains the greatest need for Covid testing today.
“The AscencioDx Covid-19 Test covers 99.99% of all Omicron variants as well as prior variants of concern. Users in our clinical trial sites appreciated its speed, reliability and ease of use.
“AscencioDx will be a pivotal platform for future diagnostics. We never want to lose sight of the goal that everyone deserves access to high quality, highly accurate, affordable diagnostic tests.”
Similar to more expensive polymerase chain reaction (PCR) testing, the AscencioDx Molecular Detector design uses reverse transcription loop-mediated isothermal amplification (RT-LAMP) technology and avoids sending samples to a different location.
Furthermore, the test and detector are said to create less bio waste, as the detector is reusable for at least 3,000 test cycles.