Molecular Diagnostic System Aims to Provide PCR Lab in the Palm of Your Hand for Diagnosing COVID-19 in 30 Minutes

A new molecular diagnostic system offers a significant advancement in rapid, precise and affordable diagnostic testing for the SARS-CoV-2 virus and is expected to provide results equivalent to lab-based PCR testing in less than 30 minutes.

Anavasi Diagnostics (Seattle, WA, USA) has been awarded USD 14.9 million from the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative to accelerate the launch and broad market availability of its AscencioDx molecular diagnostic platform for the detection of RNA indicative of the SARS-CoV-2/COVID-19 virus. Previous NIH funding in August 2020 had allowed the Anavasi team to pivot from HIV to COVID-19 detection. The AscencioDx uses sophisticated LAMP (loop-mediated isothermal amplification) molecular diagnostic chemistry and hardware technology to detect HIV viral variants. Now, the same approach is poised to make COVID-19 testing easier and more accurate for everyone.

The AscencioDx offers rapid test results equivalent to lab-based PCR tests, easy and comfortable lower nasal swab sampling procedure, and positive test results in approximately 30 minutes. Its detector is reusable for at least 3,000 single-use COVID-19 tests and its price is comparable to less accurate antigen tests and much lower than lab-based PCR tests. While the initial application of the AscencioDx platform is for the detection of COVID-19, the technology is a perfect platform for the future of bacterial and viral testing.

Currently in clinical trials in the US, Anavasi expects to file its submission to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) in the near future. The initial EUA submission will claim effectiveness 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 and other sites deemed appropriate by the healthcare professionals involved.

"At a time when Americans are seeking accurate testing options, our simple system promises to be the new gold standard," said Nelson Patterson, CEO of Anavasi Diagnostics. "It can provide results in approximately 30 minutes comparable to lab-based polymerase chain reaction (PCR) tests. In addition, the AscencioDx platform almost completely eliminates false positives and negatives so frontline health workers no longer need to order multiple tests to ensure an absolute diagnosis. It's a one and done process that's like having a PCR lab in the palm of your hand. We believe that fast, accurate and affordable testing will lead to faster treatment and better healthcare outcomes for patients. We want to save lives."

"The AscencioDx will set a new precedent in rapid affordable, simple-to-complete COVID-19 testing," said Patterson. "When our clinical testing is complete and our submission presented to the FDA, we expect results to demonstrate that no point-of-care test is more accurate. The novel combination of features will make this product unique in the marketplace."

"Future products are expected to include an all-in-one multiplex capability for testing various respiratory diseases at one time, which may ultimately provide impressive accuracy and flexibility, while also saving time and money," Patterson added.

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