Health Canada has granted authorisation to medical diagnostics firm bioLytical Laboratories’ iStatis COVID-19 Antigen Home Test.
The Interim Order authorisation will enable the company to sell the Covid-19 antigen test across Canada for use at home.
Built on the company’s testing platform INSTI, the new test is portable and can be performed at home with easy-to-understand results.
The company stated that the lateral flow diagnostic technology helps to ensure reliable access to Covid-19 tests for Canadians.
bioLytical Laboratories CEO Rob Mackie said: “We are excited to offer Canadians a Covid-19 test that they can take in the comfort and privacy of their own homes.
“With this new test, we can help our home country get access to an accurate test when and where they need one.
“With the continuing scarcity of available home antigen tests, we saw an opportunity to support our country with a reliable home test from a local manufacturer they can trust.”
The company noted that the iStatis COVID-19 Antigen Home Test will help to identify infection and reduce the virus’ transmission and exposure by giving Canadians the option of a simple Covid-19 test at home.
It also allows people to make informed health decisions at work, at home and in their communities.
For sale and distribution across Canada, the antigen test kits will be manufactured at bioLytical’s ISO 13485: MDSAP-certified facility located in Richmond, British Columbia.
The company is working to ensure the availability of test kits across Canada.
Prior to this development, the test received CE Mark for immediate entry into the European market.