First universal standard for genetic test approved by UN health agency
The United Nations World Health Organization (WHO) today approved the first-ever international standard for a human genetic test to identify a person's predisposition to blood clots, which could enable people to take preventive measures.
"Establishment of the first international standard for a genetic test is an important milestone," said Dr. David Wood, a senior official responsible for the quality and safety of biologicals at WHO. "This new standard will help to ensure that the tests are giving accurate results worldwide."
The newly established standard relates to the testing of patients for a particular genetic mutation known as "Factor V Leiden." Discovered in 1994, the mutation is one of the most common genetic risk factor for venous thrombosis, which involves 20 per cent to 40 per cent of all cases, according to WHO statement issued from its headquarters in Geneva.
The test for Factor V Leiden is one of the most frequent genetic tests carried out in clinical laboratories, the agency said. It determines the presence or absence of the mutation, which has been shown to results in a seven-fold to 80-fold higher risk of thrombosis depending on whether the carries one or two copies of the genes respectively.
The new standard is the result of joint efforts by 10 international experts from academia, industry and national regulatory authorities, as well as 25 advisors representing the WHO Expert Committee on Biological Standardization. The Committee's three-day meeting ends tomorrow in Geneva.
WHO has established more than 300 standards covering vaccines, blood products, therapeutic biological products such as insulin, and diagnostic tests such as those that detect HIV in a blood product.
WHO officials said researchers were currently investigating whether there was a link between air travel and deep vein thrombosis, adding that having information about their genetic make-up could allow travellers at risk to take additional precautions.
The standard for Factor V Leiden was developed by WHO partner and the leading international laboratory for biological standards, the National Institute for Biological Standards and Control (NIBSC) in the United Kingdom, in collaboration with experts from other institutions.