Anavasi Diagnostics has submitted the required emergency use authorization (EUA) Clinical Study Data of its COVID-19 molecular diagnostic platform to the U.S. Food and Drug Administration (FDA).

The AscencioDx COVID test enables highly accurate results in about 30 minutes, according to the company. It does so at a lower cost and with secure reporting capabilities that do not require Bluetooth or cellular coverage. This aims to help meet the continuing needs of frontline healthcare providers and other professionals completing testing outside of hospitals in workplaces and other public spaces.

The initial EUA submission for the COVID test requests approval to claim effectiveness of the AscencioDx for administration by a licensed medical professional in a point-of-care setting, including physician offices, hospital emergency rooms, urgent care clinics, mobile testing sites, colleges, and universities, as well as workspaces, primary educational facilities and other sites deemed appropriate by the healthcare professionals involved.

Anavasi is a medical technology company focused on the development of novel molecular diagnostic testing. It uses a proprietary patent-pending reverse transcriptase multiplex viral RNA detection methodology to quickly detect the presence of target viruses. 

“Testing is going to be a routine practice for many as we emerge from the COVID-19 pandemic and look to prepare for possible new variants to come, while also addressing current variants. To protect themselves, their families, co-workers and others, people will need and seek accurate and cost-effective testing options. Our easy-to-use system promises to be the new gold standard,” says Nelson Patterson, president & CEO of Anavasi Diagnostics.

The AscencioDx works by employing a lower nasal swab sampling procedure and uses multiplex viral RNA detection molecular diagnostic chemistry and hardware technology first developed at the University of Washington to detect and differentiate HIV viral variants. Now, the same approach is poised to make molecular diagnostic COVID-19 testing easier and more accessible for everyone since frontline healthcare workers will no longer need to order multiple tests to ensure an absolute diagnosis.

The design of the AscencioDx assay chemistry has been reviewed by the RADx Variant Task Force. The AscencioDx’s unique biochemistry approach to multiple target detection has been deemed well-positioned to identify future variants of COVID-19 and can be leveraged to detect other bacterial and viral infections as well.

“We developed the AscencioDx platform with a clear goal in mind: quick, accurate, and affordable testing will lead to better health outcomes for patients, and will ultimately save lives,” says Patterson. “It is why we do what we do, and why great innovation will help conquer this pandemic.”