Vancouver’s Victory Square Health has been granted approval in the European Union to commence marketing, sales and distribution for its Safetest ELISA Covid-19 antibody test.
Victory Square Health acquired Brazilian Covid19 test developers Safetest in June.
The European Union approval comes on the heels of Safetest being granted permission by the Food & Drug Administration (FDA) in the United States last month and receiving Anvisa approval for the Country of Brazil last week.
“Our ongoing mission is to help the global community curb the spread of Covid-19 by delivering the best tests in the market,” said Felipe Peixoto, CEO of VS Health. “This approval from the European Union now allows us to expand our sales and distribution reach of our Safetest suite of tests throughout the EU,” said Peixoto.
Peixoto continued, “the Company will immediately look for manufacturing capabilities in the EU to meet the strong demand.”
The antibody data provided by the Safetest Covid-19 IgM/IgG Elisa test kit covers both immunoglobulins type M (IgM) and G (IgG). When IgM antibodies are present, they can indicate that a patient has an active or recent infection with SARS-CoV-2. When IgG antibodies are present, it indicates a past infection and exposure.