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Press release content from PR Newswire. The AP news staff was not involved in its creation.

Vivera Pharmaceuticals Issues Statement Regarding LuSys Laboratories COVID-19 Tests

January 14, 2022 GMT
Vivera Pharmaceuticals, Inc. Logo (PRNewsfoto/Vivera Pharmaceuticals, Inc.)
Vivera Pharmaceuticals, Inc. Logo (PRNewsfoto/Vivera Pharmaceuticals, Inc.)
Vivera Pharmaceuticals, Inc. Logo (PRNewsfoto/Vivera Pharmaceuticals, Inc.)

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.

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The Company has reached out to FDA for correction of their recently issued advisory.

Contact: Megan Kay
megan@cerrell.com
818-850-8694

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SOURCE Vivera Pharmaceuticals, Inc.