NEWPORT BEACH, Calif., Jan. 14, 2022 /PRNewswire/ -- 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.
"It is incredibly misleading to list Vivera as a brand of LuSys or Luscient Diagnostics. Vivera works closely with leading manufacturers of FDA Emergency Use Authorized testing, such as Access Bio." Vivera Pharmaceuticals' CEO, Paul Edalat states.
The Company has reached out to FDA for correction of their recently issued advisory.