Canada-based diagnostic devices manufacturer bioLytical Laboratories has secured Health Canada approval for the launch of its iStatis COVID-19 Antigen Home Test in the Canadian market.
The test, build on bioLytical’s newest platform iStatis, is portable and delivers easy to understand results.
It can be performed in at-home comfort without the need for additional readers or machinery.
According to the company, the test showed industry-leading accuracy in clinical studies.
bioLytical chief executive officer 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 highlighted the importance of rapid testing due to the ongoing pandemic of COVID-19. It will help to keep Canadians safe and secure by identifying infections and reducing exposure and transmission.
The iStatis Covid-19 Antigen Home Test will aid people with a convenient option of easy to use home tests.
The test kits will be manufactured at the company’s facility in Richmond, British Columbia, to sell and distribute across Canada.
Recently, bioLytical secured CE Mark for the commercial launch of its iStatis Covid-19 Antigen Home Test in the European market.
Using its INSTI technology platform and its lateral flow line, iStatis, bioLytical is engaged in the development and commercialisation of rapid in-vitro medical diagnostics.
The company sells its products in Europe, North America, South America, Africa, and Asia.
