FDA Grants EUA to AscencioDx COVID-19 Test, Molecular Detector

Anavasi Diagnostics has received U.S. Food and Drug Administration Emergency Use Authorization (EUA) for the AscencioDx COVID-19 Test and AscencioDx Molecular Detector.
 
The AscencioDx COVID-19 Test can detect 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, according to the company.
 
“Accurate, quick, and affordable molecular testing remains the greatest need for COVID testing today,” Anavasi Diagnostics President/CEO Nelson Patterson said. “The AscencioDx COVID-19 Test covers 99.99% of all Omicron variants as well as prior variants of concern.”
 
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,” Patterson stated. “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.”
 
Proprietary Detector Design, Low Waste Profile
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, does not require sending a sample to a different location nor waiting days for results.
 
The AscencioDx COVID-19 Test and 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 does not need 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.
 
The AscencioDx COVID-19 Test and The AscencioDx Molecular Detector are immediately available to qualified facilities. 
 
Anavasi Diagnostics is a rapidly growing Redmond, Wash.-based medical technology company developing molecular diagnostic testing using a proprietary reverse transcriptase methodology (patent-pending). As a spin-out of the University of Washington’s CoMotion incubator program, Anavasi’s technology platform was developed by renowned researchers in bioengineering, top medical device and clinical diagnostics executives, manufacturing experts, and former Microsoft software engineers. The team’s combined experience includes introducing more than 40 medical/diagnostic products, earning over 70 patents and authoring hundreds of peer-reviewed research publications.
 
Anavasi has raised more than $28 million in capital, including a $14.9 million contract in November 2021 from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative to facilitate the launch and broad market availability of the AscencioDx molecular diagnostic platform.