bioLytical Laboratories Inc. receives WHO PQ for its iStatis COVID-19 Antigen Home Test

• 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, British Columbia, Oct. 18, 2022 (GLOBE NEWSWIRE) — bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid in-vitro medical diagnostics, announced it has received its WHO PQ for its self-test, the iStatis COVID-19 Antigen Home Test, allowing its immediate entry into international markets.

Building on its innovative INSTI^® testing platform, bioLytical launched iStatis to continue creating reliable access to testing. With new lateral flow technology in its portfolio, bioLytical can reach more people, creating equitable access to a rapid COVID-19 antigen self-test that provides peace of mind with industry-leading accuracy.

“We are excited to announce iStatis in additional global markets after receiving our WHO PQ with our COVID-19 rapid antigen self-test,” said Rob Mackie, Chief Executive Officer of bioLytical. “With various global regions with a low supply of high-quality tests, we saw an opportunity to provide rapid tests to more markets. We are proud to work with the WHO to help underserved markets and to open up equitable testing access globally.”

With the unpredictable nature of the pandemic, testing will continue to play an integral role in the fight against COVID-19 as an extra layer of defense to keep communities safe. With varying transmission levels in different global regions, the iStatis COVID-19 antigen self-test will help create certainty as a tool for identifying infection. Allowing individuals to test at home helps reduce the burden on busy medical facilities. With its high accuracy, portability, and ease of use, bioLytical is working to create global access for everyone who needs a rapid test with iStatis.

bioLytical will manufacture the iStatis COVID-19 self-tests in its MDSAP: ISO 13485-certified facility in Richmond, British Columbia. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our iStatis test kits are available across international markets such as Africa, Asia, the Middle East, and South America. The iStatis COVID-19 Antigen Home Test also has received Health Canada authorization and its CE Mark for self-testing across Canada and Europe.

bioLytical Laboratories Inc. is a privately-owned Canadian company focused on the research, development, and commercialization of rapid in-vitro medical diagnostics using its proprietary INSTI® technology platform and its lateral flow line iStatis. bioLytical has won several local and industry awards, including B.C. Exporter of the Year in 2019. We have been named Lifesciences B.C.’s Growth Stage Med Tech Company of the Year and are featured on B.C.’s Fastest-Growing Companies for six years in a row, including the Globe and Mail’s Fastest Growing Companies list in 2020. bioLytical moved to a significantly larger, state-of-the-art facility in Richmond, B.C., in 2020 to accommodate the extraordinary growth achieved through our team. Providing accurate results in one minute or less, the INSTI® range includes the INSTI® HIV-1/HIV-2 Antibody Test, INSTI® Multiplex HIV Syphilis Ab Test, INSTI® HIV Self Test, INSTI® Covid-19 Antibody Test, and the INSTI® HCV Antibody Test. bioLytical sells its products in Europe, North America, South America, Africa, and Asia. In 2022, bioLytical launched iStatis, its new lateral flow testing platform to create additional access to testing worldwide.

By delivering accurate results in real-time, INSTI® and iStatis generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide and is a key partner in tackling some of the world’s most severe healthcare challenges. Please visit www.istatis.com and www.insti.com and www.biolytical.com for more information.

References
https://www.who.int/publications/i/item/WHO-2019-nCoV-SurveillanceGuidance-2022.1

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/1f99cf04-8303-4204-8a66-fe352eb5f47e