Quote:

---

Only one antibody test has received emergency use authorization in the U.S., according to the FDA. (As part of the administration’s response to the pandemic, the FDA is using its emergency powers to grant temporary authorizations to certain tests and treatments given the lack of alternative options for COVID-19. An EUA doesn’t indicate that the FDA approved or cleared the therapy or test.)
That company is Cellex Inc., a privately held company with research operations in Research Triangle Park, N.C. Separately, Stanford Health Policy is running a project testing volunteers in California’s Santa Clara County to see if they have been exposed to the virus, with a goal of obtaining FDA authorization, according to The Mercury News. The Centers for Disease Control and Prevention has also said it is building a serological test, while New York Gov. Andrew Cuomo said this week that the state’s health department had developed an antibody testing regimen that will seek FDA authorization.

The FDA said Tuesday that more than 70 companies have told the agency that they have serological tests; however, some companies are reportedly claiming their tests are approved, authorized or can diagnose COVID-19 when they are not or cannot .

---