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Home-Use COVID Antigen Test Approved

12/16/2020

The U.S. Food and Drug Administration has granted Emergency Use Authorization for a viral antigen test developed by Ellume USA, LLC. located in Valencia, CA.

 

Ellume developed the test after receiving a $30 million contract and technical support from the RADx Tech. Program managed by the National Institute of Biomedical Imaging and Bioengineering.  This initiative was launched in late April 2020 to accelerate development and commercial application of technology relevant to the diagnosis and treatment of infectious diseases.

 

The test is performed on a nasal flush sample that is inserted into a cartridge.  The qualitative result is read using a smart phone with a result within fifteen minutes.  It is anticipated that Ellume will be able to produce home tests in million quantities during 2021. Initial projections are for a cost in the region of $30, but obviously with increased volume of production, price will be reduced.