RTP firm receives FDA approval for first coronavirus antibody test in US
A Triangle life sciences company has received the first FDA approval for an antibody test for COVID-19, another laurel for the Research Triangle’s role in combatting the global pandemic.
On Thursday, the U.S. Food and Drug Administration sent a letter to Research Triangle Park’s Cellex issuing it an emergency use authorization (EUA) for its test. The authorization gives the company the ability to manufacture and distribute the product.
The test is approved by the agency for use in diagnosing COVID-19, but its ability to detect whether a patient’s blood contains antibodies to fight the virus gives health workers a way to determine whether someone may have already contracted the virus and now may have some immunity.
“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,” the letter says, “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.”
The test is the first approved by the FDA in the U.S. that looks for antibodies in the blood rather than using nose or throat swabs. Testing samples for the product are obtained through a finger prick.
According to Cellex’s materials submitted to the FDA, the test is capable of producing a result within 15 minutes – giving providers another tool for mass testing of patients.
Cellex is located off Alexander Drive in Research Triangle Park. The company also has offices in China, where its manufacturing center is based. The company reports less than 20 employees in the Triangle, according to the North Carolina Biotechnology Center.
Under the emergency authorization from the FDA, the company is required to “clearly” state on its packaging that the product has not been FDA approved, is only for use in authorized offices and only for the duration of the public emergency period declared by the FDA.
Testing capacity has been a constant issue throughout the nation’s response to the pandemic, with North Carolina officials saying that an initial lack of supplies limited testing capacity in the early days of the outbreak. As of Thursday, 28,679 tests had been reported by the North Carolina Department of Health and Human Services.
Cellex is not the only Triangle biotechnology company working on testing capacity. In March, Morrisville-based Heat Biologics announced a partnership with the University of Miami to develop its own test.
A slew of Triangle universities, research institutes and drugmakers are also pushing forward with their own treatments or studies of the virus.