AscencioDx system leverages advanced LAMP molecular diagnostic technology, to provide results equivalent to PCR testing within 30 minutes
Clinical Research Center at NIH. (Credit: Duane Lempke/Wikipedia.)
Anavasi Diagnostics has received a $14.9m grant from the National Institutes of Health (NIH) to commercialise its AscencioDx molecular diagnostic platform.
The funding, received under NIH’s Rapid Acceleration of Diagnostics (RADxSM) initiative, will be used to advance the rollout and marketing of the AscencioDx molecular diagnostic platform, designed to detect the RNA indicative of the SARS-CoV-2.
Anavasi is currently studying the test in US clinical trials, with plans to seek the emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) in the near future.
In the initial EUA submission, the company intends to claim the effectiveness of the test in a point-of-care setting, for administration by a licensed medical professional.
Also, AscencioDx has potential for at-home use, based on its technology and easy-to-perform testing method, said the company.
Anavasi Diagnostics CEO Nelson Patterson said: “We are honoured that the NIH has recognised the AscencioDx molecular diagnostic system as a significant advancement in rapid, precise and affordable diagnostic testing for the SARS-CoV-2 virus.
“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.”
AscencioDx leverages advanced loop-mediated isothermal amplification (LAMP) molecular diagnostic technology, originally developed at the University of Washington to detect HIV viral variants.
Based on its origins of detecting HIV variants, the technology supports the detection of other viruses such as Influenza A and/or B, along with respiratory syncytial virus.
In August last year, Anavasi has secured NIH funding that allowed the firm to pivot from HIV to Covid-19 detection.
The current NIH funding will support the hiring of additional production staff, and the acquisition of improved manufacturing automation equipment, said the company.
Also, it will further develop Anavasi’s healthcare reporting capabilities through a reporting platform sponsored by the US Department of Health and Human Services (HHS).
Patterson said: “The AscencioDx will set a new precedent in rapid affordable, simple-to-complete Covid-19 testing.
“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.”