REDMOND, Wash.– Anavasi Diagnostics, an NIH/RADx funded medical technology company developing novel molecular diagnostic testing for the point-of-care (POC) market, announced the Food and Drug Administration has issued an Emergency Use Authorization (EUA) for The AscencioDx® COVID-19 Test and The AscencioDx® Molecular Detector.
The AscencioDx® COVID-19 Test provides results for the detection of SARS-CoV-2 RNA in as little as 20 minutes. The affordability and portability of the AscencioDx system enables quality point-of-care molecular testing in a wider range of healthcare environments, including facilities such as urgent care centers, mobile testing sites, assisted nursing care centers, and more.
“Accurate, quick, and affordable molecular testing remains the greatest need for COVID testing today,” said Nelson Patterson, President and CEO of Anavasi Diagnostics. “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 test uses proprietary assay chemistry to target multiple locations on the viral genome, reducing the likelihood of missing a new strain. In addition, the AscencioDx proprietary platform will enable rapid product development of new viral and bacterial targets, including influenza, RSV, sexual health-related strains, and more.
“Anavasi Diagnostics was founded on the principle that better diagnostics lead to better health outcomes,” said Patterson. “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.”
The AscencioDx Molecular Detector’s proprietary compact design uses RT-LAMP (reverse transcription loop-mediated isothermal amplification) technology similar to more expensive and complex PCR testing, but unlike PCR testing, doesn’t require sending a sample to a different location nor waiting days for results.
The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector create less biowaste because the detector is reusable for at least 3,000 test cycles. Unlike most single-use molecular tests, it doesn’t require batteries or electronic components to be thrown away after a single use. The AscencioDx system has minimal packaging and fewer disposable components than other molecular POC tests.
“Clinicians have told us they want COVID-19 testing that is convenient, reliable, and does not significantly add to their biohazard waste,” said Scott Robitaille, Vice President for Sales and Marketing for Anavasi Diagnostics.
