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BioLytical Laboratories Receives CE Marking for COVID-19 Antigen Test

NEW YORK – Canadian diagnostic firm bioLytical Laboratories announced on Monday that its iStatis COVID-19 Antigen Home Test has received CE marking and will be launching across Europe. 

The portable lateral flow test has shown accuracy of 100 percent in clinical studies, the company said in a statement. The firm will manufacture the at-home test in Richmond, British Columbia, and "is working to ensure" the kits are available across Europe, it added.

In addition to its lateral flow platform iStatis, bioLytical also offers its Insti range of antibody tests, which includes an HIV-1/HIV-2 antibody test, a multiplex HIV syphilis Ab test, an HIV self-test, a COVID-19 antibody test, and a hepatitis C antibody test, which received CE marking in July.