NEW YORK – Anavasi Diagnostics announced on Tuesday that it has received $14.9 million from the National Institutes of Health's Rapid Acceleration of Diagnostics initiative to commercialize its rapid molecular COVID-19 test.
The RADx funding will be used to accelerate the launch and market availability of the AscencioDx test, Anavasi said in a statement. Namely, it will be used to hire additional production staff, acquire improved manufacturing automation equipment, and further develop the company's portal for healthcare reporting. The portal is sponsored by the US Department of Health and Human Services, Anavasi said.
The test uses loop-mediated isothermal amplification to detect SARS-CoV-2 from nasal swabs in approximately 30 minutes. The assay's detector can be used for at least 3,000 single-use tests and the price will be comparable to antigen tests, the Woodinville, Washington-based company said.
The AscencioDx test is currently in clinical trials and Anavasi plans to submit the test to the US Food and Drug Administration for Emergency Use Authorization "in the near future," the company said.
The initial submission will be for use by a medical professional at the point of care, including at physicians' offices, emergency rooms, urgent care centers, mobile testing sites, universities, and workplaces. However, the company said the test has potential for at-home use.
Anavasi previously received $250,000 in NIH funding last year to pivot its business from HIV to COVID-19 detection. It has raised $2.6 million in funding to date, and recently closed a $6 million convertible promissary note round, a spokesperson for the company said.
The platform, developed at the University of Washington, could also be used for other viruses. "Its origins detecting HIV variants make it ideal for the additional detection of other viruses such as influenza A and/or B, as well as respiratory syncytial virus," Anavasi CEO Nelson Patterson said in a statement.
Future products will include a multiplex respiratory disease test, Patterson added.