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bioLytical Laboratories Inc. receives WHO PQ for its iStatis COVID-19 Antigen Home Test
bioLytical Laboratories Inc. announced its immediate entry into the African, Asian, Middle Eastern, and South American markets with its COVID-19 home test on its new lateral flow platform, iStatis
- From the makers of INSTI®, bioLytical launches a new platform, iStatis, created to ensure every person in the world has access to reliable testing
- bioLytical receives eligibility for its self-test, the iStatis COVID-19 Antigen Home Test, for international, regional, and national procurement agencies for immediate entry into the African, Asian, Middle Eastern, and South American markets
- The test is portable and can be performed in a multitude of settings with easy-to-understand results
- Test performance in clinical studies demonstrated high accuracy, with industry-leading sensitivity and specificity
- bioLytical’s quality system is MDSAP: ISO 13485 certified
Richmond, B.C., October 18, 2022 – bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced today that it is launching its iStatis COVID-19 Antigen Home Test after receiving Health Canada Interim Order authorization, allowing its immediate entry into the Canadian market.
Building on its innovative INSTI® testing platform, the iStatis COVID-19 Antigen Home Test is on bioLytical’s newest platform, iStatis. With this additional lateral flow diagnostic technology, bioLytical can continue to reach more people, helping to provide peace of mind to Canadians looking to make informed health choices.
“We are excited to offer Canadians a COVID-19 test that they can take in the comfort and privacy of their own homes,” said Rob Mackie, Chief Executive Officer of bioLytical. “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.”
As the world learns to live with COVID-19, rapid testing is a vital tool to help identify infection and reduce exposure and transmission. Conducting regular testing provides an extra layer of defense. Home tests offer a convenient option to help Canadians make informed health decisions at home, at work, and in their communities.
To keep Canadians safe and secure, reliable testing access is necessary. Throughout the pandemic, healthcare systems were overwhelmed across the country. Along with the lack of PCR testing and scarcity of rapid antigen tests, it was difficult for Canadians to find and take COVID-19 tests when they needed one. With its high accuracy, portability, and ease of use, the iStatis COVID-19 Antigen Home Test will provide Canadians with a trusted home option.
bioLytical will manufacture the iStatis COVID-19 Antigen Tests in its ISO 13485: MDSAP-certified facility in Richmond, British Columbia, to sell and distribute across Canada. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our iStatis COVID-19 Antigen Home Test kits are available to Canadians so they can know their status faster.
Contact
Stephanie Ritchie
Communications Specialist
778.238.9340
sritchie@biolytical.com
Source: https://biolytical.com/biolytical-laboratories-inc-receives-who-pq-for-its-istatis-covid-19-antigen-home-test/
"Reproduced with permission - "bioLytical Laboratories Inc."
bioLytical Laboratories Inc.
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