RTP company behind first FDA authorized antibody-based test for COVID-19
A Research Triangle Park-based company has received emergency-use authorization from the Food and Drug Administration for an antibody-based test it developed for COVID-19, the disease caused by the novel coronavirus.
The company, Cellex, received authorization to begin using the test from the FDA on April 1. The FDA said it would start considering certain medical devices for emergency-use authorization starting on Feb. 4 because of the threat the COVID-19 outbreak poses. It can often take more than a year for companies to get drugs or devices approved by the FDA as they must go through tests showing they are safe and effective.
But the FDA can make certain devices — or in this case tests — available through an emergency-use authorization, when situations like COVID-19 justify their immediate need. The U.S. has struggled to ramp up testing for COVID-19, and the FDA took action to “achieve more rapid and widespread testing capacity in the United States.”
Antibody tests can determine whether a person’s blood has developed antibodies that fight the coronavirus. That data could show who has had the virus and whether they have developed some immunity. The New York Times reported that Italy might use antibody tests to determine which of its civilians are allowed to go back to work.
Cellex’s test uses a blood sample and takes around 15 to 20 minute to get a result, according to an application the company sent to the FDA. It is the first test approved in the U.S. that looks for antibodies in blood, the tech news site The Verge reported.
The FDA cautions on its fact sheet for Cellex’s test that it is technically “not yet approved or cleared” by the FDA. Its emergency approval will remain in effect, the FDA said, for the duration of the pandemic.
Politico reported that the Centers for Disease Control plans to use antibody tests to help determine the numbers of people infected by the coronavirus, including those who were asymptomatic.
The test could give a clearer view of how widespread the disease has been in the population, the Times reported. Because many people who are asymptomatic are not currently getting tested, an antibody test could help determine the number of people who were infected but did not become ill.
Founded in Maryland in 2002, Cellex moved its headquarters and research and development team to Research Triangle Park. The company creates different kinds of instruments and assays for testing of disease and conditions. It also has a manufacturing site in China. Efforts to reach Cellex for comment were not successful.
In its letter to Cellex the FDA said, “It is reasonable to believe that your product may be effective in diagnosing COVID-19.”
Another Triangle company, the Spanish biotech firm Grifols, plans to use its large Clayton facility to process blood from recovered COVID-19 patients in an effort to harvest coronavirus-fighting antibodies.
The hope is that Grifols can use these antibodies to develop treatments for COVID-19 patients.
This story was produced with financial support from a coalition of partners led by Innovate Raleigh as part of an independent journalism fellowship program. The N&O maintains full editorial control of the work. Learn more; go to bit.ly/newsinnovate
This story was originally published April 8, 2020 at 11:11 AM with the headline "RTP company behind first FDA authorized antibody-based test for COVID-19."
