RTP Company Gets Federal Approval for First in US Coronavirus Antibody Test

RALEIGH – Cellex, a biomedical company based in North Carolina’s Research Triangle Park, has just received an Emergency Use Authorization from the FDA for immediate manufacture and distribution of its innovative antibody test for use in the fight against COVID-19. The test detects whether a patient’s blood contains antibodies to fight the novel SARS-CoV2 that caused COVID-19, and meaning the person has already contracted the virus and now has immunity.

From the Triangle Business Journal:

“[…] 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. […]”

Home to a biomedical hub and some of the nation’s leading research institutions, North Carolina is bound to make a big contribution toward innovative resolutions to our current crisis. Read more about how Cellex got its start, and the promising new test, here.