Anavasi Diagnostics has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its AscencioDx COVID-19 Test and AscencioDx Molecular Detector.

According to the US-based medical technology company, the AscencioDx COVID-19 Test delivers results for the detection of SARS-CoV-2 RNA within 20 minutes.

The company claimed that the AscencioDx system’s affordability and portability allow for point-of-care molecular testing in a broader variety of healthcare settings. These include facilities like urgent care centers, assisted nursing care centres, mobile testing sites, and others.

By using proprietary assay chemistry, the AscencioDx COVID-19 Test is said to target various locations on the viral genome, thereby decreasing the chances of missing a new strain.

Additionally, the AscencioDx platform will facilitate fast product development of new viral and bacterial targets such as influenza, sexual health-related strains, respiratory syncytial virus (RSV), and others, said Anavasi Diagnostics.

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.”

The other product, which is the AscencioDx Molecular Detector, is said to have a compact design. It uses the reverse transcription loop-mediated isothermal amplification (RT-LAMP) technology.

RT-LAMP is similar to PCR testing, which is more expensive and complex, said Anavasi Diagnostics. However, in contrast to PCR testing, the AscencioDx Molecular Detector does not need sending a sample to a different location nor are there any waiting days to get results, stated the medical technology company.

The company claimed further that the AscencioDx COVID-19 Test and AscencioDx Molecular Detector produce less biowaste as the detector can be reused for at least 3,000 test cycles.

In November 2021, Anavasi Diagnostics secured a $14.9m grant from the US National Institutes of Health (NIH) to commercialise its AscencioDx molecular diagnostic platform.