Gene tests fail approval hurdle
Tuesday July 26th, 2011
Two commercial gene chip tests to help identify people with inherited high cholesterol levels are not likely to be used on the NHS, it was announced today.
The
tests do not identify enough of the hundreds of genes linked to the condition
- in spite of their low-cost and speed, according to experts at the National
Institute for Health and Clinical Excellence.
NICE has urged the use of genetic testing to identify familial hypercholesterolaemia and says it is disappointed that more does not take place.
As the problem runs strongly in families, NICE believes that successfully identifying the genetic mutations affecting one family member means that others need only be tested for those genes.
But today it says the two tests will not help accelerate the process because of their flaws.
Some 1,400 gene mutations linked to the condition have been found worldwide and 200 have been identified in Britain.
One test, Elucigene, detects 20 genetic mutations while a second, Lipochip, can detect 189.
In provisional recommendations, NICE says doctors should stick with the process of comprehensive genetic analysis - CGA - on people suspected of having the problem.
Professor Adrian Newland, chair of its diagnostics advisory committee, said: "Despite the recommendations in the NICE clinical guideline, uptake of DNA testing for familial hypercholesterolaemia has remained low, primarily because clinical capacity for identifying and managing the condition in index individuals and their relatives is not currently adequate in the NHS.
"Knowing the specific family mutation means that, as part of cascade testing, the individual’s relatives can be offered a simple targeted DNA test where the laboratory tests just for the family mutation."
Tags: Genetics | Heart Health | UK News
Printer friendly page