WHO Prequalifies First Hepatitis C Diagnostic

Posted 05 December 2016 By Zachary Brennan

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The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

The prequalification of South Korea-based Standard Diagnostics’ point-of-care diagnostic, called SD BIOLINE HCV, comes as an increasing number of people in low- and middle-income countries are now gaining access to hepatitis C cures from Gilead, AbbVie and Janssen, among others.

Since the introduction of these new medicines in the last two years (hepatitis C is a disease that kills almost 700,000 annually), more than one million people have been treated in low- and middle-income countries including Argentina, Brazil, Egypt, Georgia, Indonesia, Morocco, Nigeria, Pakistan, Philippines, Romania, Rwanda, Thailand and Ukraine.

The cost of the new treatments also varies significantly between the different countries, with the price for a three-month treatment ranging from $200 in Egypt to $9,400 in Brazil to $79,900 in Romania.

“One of the chief obstacles to effective testing and treatment of HCV has been a lack of suitable diagnostic tests, with the result that only a small minority of people infected with HCV are aware of their status,” said UNITAID Executive Director, Lelio Marmora. “We are therefore greatly encouraged by the news that a WHO-prequalified rapid diagnostic test for HCV can now be made available to those most in need.”

Resembling a pharmacy pregnancy test and providing results in 20 minutes, WHO says the prequalified diagnostic also does not require hospital facilities or electricity and can be performed by health workers with limited training.

“The majority of people with chronic hepatitis C don’t know they have the infection and miss the opportunity to be cured,” said Dr Gottfried Hirnschall, WHO Director for the Department of HIV and Global Hepatitis Programme. “Making the first WHO prequalified test available in countries can greatly contribute to achieving the goal of eliminating hepatitis.”

 

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Categories: In vitro diagnostics, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Europe, Asia, Latin America and Caribbean, Africa, Middle East, WHO

Tags: WHO, prequalification, Gilead, Hepatitis C

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