Canadian Manufacturing

bioLytical Laboratories Inc. receives Health Canada authorization for its iStatis COVID-19 antigen test

by CM Staff   

Human Resources Manufacturing Regulation Research & Development Risk & Compliance Public Sector COVID-19 healthcare public sector Rapid Antigen Testing

bioLytical says it is working to ensure the iStatis COVID-19 Antigen Test kits are available to Canadians so they can know their status.

The Point-of-Care iStatis COVID-19 Antigen Test

RICHMOND — bioLytical Laboratories Inc. is launching a new testing platform, iStatis, which has received Health Canada authorization for its iStatis COVID-19 Antigen Test, allowing its immediate entry into the Canadian market.

bioLytical says it launched iStatis to continue creating access to testing. With additional lateral flow technology in its portfolio, bioLytical says it can reach more people with its COVID-19 antigen test.

“We are excited to announce the addition of iStatis with our new COVID-19 rapid antigen test,” said Rob Mackie, CEO of bioLytical in a statement.

“With this new platform, we are able to expand our reach, creating more equitable access to testing. With the scarcity of available antigen tests, we saw an opportunity to ensure that Canadians have a reliable test they can trust.”

The company says that with new variants expected to continue, testing will help reduce the spread of the virus and keeping Canadians safe at home, at work, and in society.

With overwhelmed healthcare systems across the country, lack of access to PCR testing, and a low supply of rapid tests, the iStatis COVID-19 Antigen Test will also help play a role in identifying infection and helping Canadians make safe and informed decisions regarding their health.

The iStatis COVID Antigen Test allows healthcare professionals the ability to test in multiple environments.

bioLytical will manufacture the iStatis COVID-19 Antigen Tests in its MDSAP and ISO 13485-certified facility in Richmond, BC, to sell and distribute across Canada.


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