BIOLYTICAL RECEIVES CE MARK FOR THE WORLD’S FIRST ONE MINUTE HEPATITIS C ANTIBODY RAPID TEST
BioLytical Laboratories Inc. announced today that its INSTI® HCV Antibody Test has received approval for immediate market entry into the European Union
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.”— Robert Mackie, CEO
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.
• The test is portable, does not require any additional equipment, and can be performed in a multitude of settings with easy-to-interpret results in real-time
• Test performance in clinical studies demonstrated high accuracy of over 99%
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.