genomic technology in healthcare

BIVDA’s reaction to the launch of Building on our inheritance: genomic
technology in healthcare
31st January 2012
Last week the Human Genomics Strategy Group (HGSG) launched their report Building on
our inheritance: genomic technology in healthcare. BIVDA welcome this report as a
comprehensive and thoughtful overview of genomic medicine but BIVDA still questions why
genetic or genomic tests should be singled out as being different to any other diagnostic
test. BIVDA’s Chief Executive, Doris-Ann Williams said ”there is a tendency for the public to
worry about anything related to genetics and where tests are concerned the same issues
apply equally to non-genetic/genomic tests; it is a question of the level of importance to
health relating to the information the test provides”.
She added “the results from any test which can predict the development of a serious
disease such as Huntingdon’s, which do currently tend to be genetic tests, clearly need to be
handled carefully for both counselling on diagnosis and the potential economic implications
the individual may have for obtaining insurance etc; but these questions have already arisen
in cases of individuals who have contracted for example, HIV, which is a non-genetic
Many of the issues raised in the report from the HGSG are aligned with the issues for which
BIVDA is already raising awareness such as the issue of silo budgets and funding to enable
rapid uptake of diagnostics. Another issue is identifying the right evidence level for
acceptance of diagnostics; looking at health economics models other than the QALY. If
solutions to these are identified in the area of genomic medicine then these should be
transferable to other diagnostic tests. For screening BIVDA would not expect to see new
criteria being developed separately to any modification of the Wilson and Jungner criteria
developed more than 40 years ago.
BIVDA feel it is also crucial to note that while the use of companion diagnostics and
stratified medicine is a key growth area for the in vitro diagnostics industry in the future,
these tests do not have to be genetic to play a valuable role in treatment and management
of disease.
BIVDA was also pleased to see the inclusion of the concerns around intellectual property
and infringement in NHS laboratories. The NHS is currently able to develop and use
an in-house test within individual hospitals without compliance to the current European
legislation but this does not include carte blanche to ignore commercial IP.
For more information, please contact Doris-Ann Williams on: [email protected] or
02079574633 / 07801 959926
The British In Vitro Diagnostics Association (BIVDA) is celebrating 20 years of representing the in
vitro diagnostics (IVDs) industry in the UK.
BIVDA member companies employ more than 8,000 people directly in the UK and provide the tests
and equipment to the NHS to allow rapid diagnosis. IVDs also enable screening for disease,
identifying, monitoring and managing treatment and are vital to ensure the safety of the blood
supply for transfusion. Information from IVD tests accounts for about 70% of the information on a
patient’s record. Increasingly diagnostics are available for use in a primary care setting and to enable
people to manage their own diseases from home. This reduces the need for hospitalised care and
will improve quality of life for much of the population.
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