Medical technology firm Anavasi Diagnostics has submitted the required clinical study data to seek emergency use authorisation (EUA) for its Covid-19 molecular diagnostic platform from the US Food and Drug Administration (FDA).
The AscencioDx molecular diagnostic system is designed for the detection of RNA that indicates the presence of the SARS-CoV-2/Covid-19 virus.
It uses a lower nasal swab sampling procedure, multiplex viral RNA detection molecular diagnostic chemistry and hardware technology that was initially developed at the University of Washington for the detection and differentiation of HIV viral variants.
The company stated that the same process is used to make Covid-19 molecular diagnostic testing easier and more accessible for people.
The new easy-to-use system provides accurate results in approximately 30 minutes and can be completed with secure reporting capabilities, without requiring Bluetooth or cellular coverage.
Anavasi noted that this process helps to meet the needs of frontline healthcare providers as well as other professionals completing tests in workplaces and other public spaces outside of hospitals.
Anavasi Diagnostics president and CEO Nelson Patterson said: “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.
“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.”
The initial FDA EUA submission requests approval to claim AscencioDx effectiveness for administration by licensed medical professionals in a point-of-care setting, including hospital emergency rooms, colleges, urgent care clinics, mobile testing sites, universities, workspaces and other sites.