North Triangle News

A North Carolina-based drug company received the first approval from the U.S. Food and Drug Administration for an antibody test for COVID-19. 

The approval went to the Research Triangle Park's Cellex. The emergency use authorization (EUA) from the FDA gives Cellex permission to begin distributing the test for use in identifying individuals who have encountered the novel coronavirus that causes COVID-19.

Similar to existing methods, this test will identify those currently infected, and also can determine those who have recovered from the illness and are no longer contagious, according to an April 3 report in the Triangle Business Journal. Antibodies that are part of the immune system’s response to the novel coronavirus will still be present in the bloodstreams of those who are now immune to the disease and thus incapable of transmitting it to others.

"Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19," reads a letter to Cellex from the FDA, according to the Triangle Business Journal, "and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product."

Cellex will be required to note on any packaging that the test has not had FDA approval, and is only for use in the United States during the health crisis.

The test is conducted by taking a blood sample through a finger prick, and Cellex has claimed the test can give a result within 15 minutes, rather than the weeks or days required for existing tests to be handled in a far-off lab, according to the Triangle Business Journal.

Cellex is only one of several entities in Triangle Park that have been working on an antibody test for the novel coronavirus, according to the Triangle Business Journal, and other companies and universities continue to work on different solutions.