A Richmond-based biotech company says it has received approval to sell its Hepatitis C (HCV) rapid test – the first of its kind in the world – in Europe.
The rapid test is the world’s first HCV one-minute test, according to bioLytical Laboratories, which said in a statement Monday it has received CE Mark and approval to sell the test across Europe.
A CE Mark means a product has met health, safety and environmental protection requirements to be sold in the European Union. The test kits will be manufactured in Richmond.
The Insti HCV Antibody Test was developed to identify HCV antibodies using a finger-stick method.
The company hopes the one-minute test kits – which are 99 per cent accurate based on clinical studies – will help diagnose and connect more people to care.
The kits also give medical professionals the ability to test patients easily and flexibly in different locations.
The biotech company said Hepatitis C (HCV) is a “growing international health concern,” affecting an estimated 71 million people worldwide.
People with Hepatitis C can remain asymptomatic and, therefore, undiagnosed. If left untreated, it can cause serious health problems such as liver damage, cirrhosis, liver cancer and can even be fatal.
While treatment can cure over 95 per cent of people with Hepatitus C, bioLytical said access to diagnosis remains low.
bioLytical has been selling rapid tests in Europe under its Insti line-up since 2015, including the HIV-1/HIV-2 Antibody Test, the Multiplex HIV Syphilis Ab Test, the HIV Self Test and the COVID-19 Antibody Test.
The company’s HIV Self Test was the first of its kind to be approved in Canada last year.
