GENEVA -- The World Health Organization said Wednesday it
approved the first international standard for a human genetic
test to help laboratories improve the accuracy and quality of
their results.
The standard - which will help identify testing errors - is
for a commonly used procedure that identifies a genetic predisposition
to thrombosis, or blood clots, a potentially life-threatening
condition.
Standards could also eventually be introduced for other genetic
disorders, such as cystic fibrosis and muscular dystrophy.
"Establishment of the first international standard for
a genetic test is an important milestone," said Dr. David
Wood, WHO's chief of quality assurance and safety of biologicals.
"Genetic testing procedures are playing a vital and growing
part in clinical medicine."
It is estimated that more than 700,000 genetic tests were performed
in 2002 in the European Union alone. WHO said that millions
of tests are probably being carried out globally each year.
The standard will help ensure that genetic tests are done to
a high level of accuracy, WHO spokeswoman Melinda Henry told
The Associated Press.
"The test determines if the person has a gene which would
predispose them to the illness," she explained. "The
added information (gained from using the standard) may have
implications for the patient - what medicine they have to take
- and to family members, whether they are predisposed to the
illness."
The new standard relates to the testing of patients for a genetic
mutation called Factor V Leiden, which causes a defect in the
natural anticoagulation system and is involved in 20-40 percent
of all cases of venous thrombosis.
The test to determine whether the Factor V Leiden mutation
is present is one of the most common genetic tests carried out
in clinical laboratories. The mutation can dramatically increase
the risk of contracting thrombosis by up to 80 times, depending
on whether the individual has one of two copies of the gene.
"Setting standards is particularly critical as genetic
testing has expanded to more and more laboratories throughout
the world," the agency explained. "Genetic testing
must be done consistently in all laboratories around the world
and to high-quality standards in order to give confidence in
the results."
WHO said it will likely approve standards for other genetic
tests in the future and that increasing use of standards "will
enable prevention and early treatment of genetic disorders,
improving quality of life."