Politics

FDA Commissioner Approves Coronavirus Antibody Test Produced By Cellex Inc., The First Of Its Kind

(Photo by Chip Somodevilla/Getty Images)

Christian Datoc Senior White House Correspondent
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Food and Drug Administration Commissioner Stephen Hahn announced Thursday the approval of a coronavirus antibody testing system produced by Cellex Inc., the first of its kind approved for use by FDA.

Hahn explained the details during an interview with CBS’ Steven Portnoy, adding that additional information would be provided later on Thursday, likely at President Donald Trump’s daily White House press briefing. The FDA formally notified Cellex of the test’s approval on Wednesday.

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“The antibody of course detects that one has been exposed to it,” Hahn noted, explaining the difference between this type of test and the diagnostic test previously approved by FDA. “It has a really important role to play in the surveillance of the disease particularly because this virus is different from others because we suspect there are a large percentage of people who are asymptomatic, or who have had it and then gone over without even knowing they have had it.” (RELATED: Study Raises Hope That Blood Plasma Can Treat Coronavirus Patients)

“It’s going to help us determine what is called the attack rate of the virus, how many people it can attack, and what the spread was like.”

Hahn added that FDA has “provided regulatory flexibility to other laboratories and other producers so that they can develop their own tests.”

WASHINGTON, DC - MARCH 31: White House coronavirus response coordinator Debbie Birx speaks while flanked by President Donald Trump (L), and Dr. Anthony Fauci (C), director of the National Institute of Allergy and Infectious Diseases, during the daily coronavirus task force briefing in the Brady Briefing room at the White House on March 31, 2020 in Washington, DC. With the nationwide death toll rising due to the coronavirus, the United States has extended its social distancing practices through the end of April, while many states have issued stay-at-home orders that strongly discourage residents from leaving home unless absolutely necessary or essential. (Photo by Win McNamee/Getty Images)

WASHINGTON, DC – MARCH 31: White House coronavirus response coordinator Debbie Birx speaks while flanked by President Donald Trump (L), and Dr. Anthony Fauci (C), director of the National Institute of Allergy and Infectious Diseases, during the daily coronavirus task force briefing in the Brady Briefing room at the White House on March 31, 2020 in Washington, DC. (Photo by Win McNamee/Getty Images)

“We’re expecting a significant expansion in the next couple of weeks,” he continued. “We want to use that both in the laboratory setting and the public health setting so we can do the type of surveillance Dr. [Deborah] Birx was talking about.”

Birx, the White House coronavirus task force response coordinator, and Dr. Anthony Fauci have repeatedly stressed the need to develop approved antibody tests to help surveil the spread of, and recovery from, coronavirus among medical professionals on the front line of the pandemic.