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BioLytical Laboratories Nabs Health Canada Interim Order Authorization for At-Home COVID-19 Test

NEW YORK ─ BioLytical Laboratories on Friday announced that it has obtained Health Canada interim order authorization for the iStatis COVID-19 Antigen Home Test and is launching it in Canada for home use.

BioLytical said it will manufacture the antigen test at its facility in Richmond, British Columbia.

In March, the Canadian diagnostic firm announced it had received CE marking for the test, which is the second assay BioLytical is launching with its iStatis lateral flow platform.

Biolytical announced in March that it had received authorization from Health Canada for its point-of-care iStatis COVID-19 Antigen Test, which is implemented by healthcare professionals.

Last November, the company obtained Canadian authorization for a one-minute COVID-19 antibody test that uses fingerstick blood samples, which was developed with funding from the National Research Council of Canada Industrial Research Assistance Program.