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4th August 2021  Product update: rapidvirology staff writer

CE-Mark for World's First 1-Minute Hepatitis C (HCV) Antibody Rapid Test

bioLytical Laboratories Inc. has announced that its INSTI® HCV Antibody Test has received approval for immediate market entry into the European Union by its Notified Body. 

The innovative rapid through-flow technology allows INSTI® to provide accurate test results in real-time, offering medical professionals the ability to test patients easily and flexibly in different locations.  

Affecting an estimated 71 million globally, Hepatitis C (“HCV”) is a growing international health concern. It can remain asymptomatic and thus undiagnosed, and if left untreated, can cause serious health problems, including liver damage, cirrhosis, liver cancer, and even death.  

With both taking the test and receiving results in real-time, bioLytical’s INSTI® HCV Antibody Test will help connect more people to care. Treatment can cure more than 95% of people with Hepatitis C, but access to diagnosis is still too low. Ending an epidemic starts with testing. That’s why we’ve developed an all-new, one-minute solution for HCV antibody testing.  

“By using our proven INSTI® platform, we were able to take advantage of our rapid test technology to develop a fast and easy-to-use test with over 99% accuracy,” said Robert Mackie, CEO for bioLytical. “Ending HCV in Europe begins with testing. By providing access to the world’s first one-minute HCV test, we are excited to play a role in reducing transmission in Europe to help diagnose and connect individuals to care.”  

Leveraging bioLytical’s proven INSTI® technology, the INSTI® HCV Antibody Test was designed to identify HCV antibodies, paving the way for reliable and fast screening using a simple fingerstick method to receive results that are more than 99 percent accurate in only one minute. bioLytical will manufacture the INSTI® HCV Antibody Tests in its facility in Richmond, British Columbia, to sell and distribute across Europe.  

To learn more, use the 'Request Information' facility below or visit bioLytical.com.



Date Published: 4th August 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.

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