Vivera Pharmaceuticals is highly discouraged to read the latest FDA safety communication that erroneously lists Vivera Pharmaceuticals as a brand of LuSys Laboratories or as a distributor of the LuSys Eagle Diagnostics test.
While Vivera did work with LuSys Laboratories in mid-2020, the scope of that engagement was limited to development of a United States made antibody test for COVID-19. At the time, Vivera was working closely with the White House and the office of Dr. Peter Navarro in development of domestically manufactured COVID-19 testing.
FDA’s misrepresentation of the relationship between LuSys and Vivera is damaging to Vivera and the customers and patients it serves, as Vivera does not distribute any non-Emergency Use Authorized, or notified, testing.
The Company has reached out to FDA for correction of their recently issued advisory.