Anavasi Diagnostics Announces FDA EUA Submission for Its COVID-19 Test
AscencioDx® Molecular Diagnostic System Expected to Provide Results Equivalent to Lab-Based PCR Testing in Less Than 30 minutes, pending EUA Certification from the FDA
WOODINVILLE, Wash., March 15, 2022 /PRNewswire/ -- Anavasi Diagnostics announced today that it has submitted the required EUA Clinical Study Data for the AscencioDx®, the molecular diagnostic platform for the detection of RNA indicative of the presence of the SARS-CoV-2/COVID-19 virus, to the Food and Drug Administration (FDA). 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.
The AscencioDx represents a new generation of point-of-care molecular diagnostic testing that enables highly accurate results in about 30 minutes. It does so at a lower cost and with secure reporting capabilities that do not require Bluetooth or cellular coverage. This helps meet the continuing needs of frontline healthcare providers and other professionals completing testing outside of hospitals in workplaces and other public spaces.
"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," said Nelson Patterson, President & CEO of Anavasi Diagnostics.
The AscencioDx works by employing an easy and comfortable lower nasal swab sampling procedure and uses sophisticated 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 forward-thinking 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.
The initial EUA submission 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. Based on its technology and easy-to-perform test procedure, the AscencioDx has potential for at-home use pending further clinical validation and FDA clearance.
"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," noted Patterson. "It is why we do what we do, and why great innovation will help conquer this pandemic."
Anavasi Diagnostics: RADx® Portfolio Company
The AscencioDx molecular test is supported by the NIH Rapid Acceleration of Diagnostics (RADx®) initiative and has been funded in part with federal funds from National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92022C00005.
"Our submission is the culmination of significant effort by the Anavasi team, as well as countless contract partners," added Patterson. "We are especially grateful for the continued support, coaching, and resources available to us as a RADx® portfolio company through the NIH."
About Anavasi Diagnostics (www.anavasidx.com)
Anavasi Diagnostics is a medical technology company focused on saving lives by developing novel molecular diagnostic testing using a proprietary patent-pending reverse transcriptase methodology. It was founded by world-leading university researchers, top medical device and clinical diagnostics executives, manufacturing experts and a former Microsoft software veteran. Throughout their careers, the team has collectively been responsible for the introduction of more than 40 medical/diagnostic products, seven (7) successful start-up exits, over $500 million in raised capital, over 75 patents, and hundreds of peer-reviewed research publications.
SOURCE Anavasi Diagnostics
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