NEW YORK ─ BioLytical Laboratories said on Monday that it has received the CE mark for its Insti HCV Antibody Test, enabling its sale in Europe.
The antibody test is 99 percent accurate and detects hepatitis C antibodies, providing results in one minute and enabling medical professionals to test patients in different locations, the firm said.
BioLytical said it will manufacture the tests in its Richmond, British Columbia, facility. It runs on the firm's Insti through-flow platform, which performs antibody testing from fingerstick whole-blood samples.
In May, the National Research Council of Canada Industrial Research Assistance Program awarded the firm C$633,000 ($460,000) in funding to develop a test for antibodies to SARS-CoV-2.