Memorandum by Roche Diagnostics Ltd
Roche Diagnostics is particularly keen to provide
views on the specific question raised in relation to the take
up of new surveillance and diagnostic technologies. Roche Diagnostics
is a leading provider of diagnostic systems and decision-oriented
health information technologies. It undertakes the research, development
and distribution of diagnostic tools that are used in a wide range
of situations, including by technicians in medical laboratories,
by doctors and nurses in hospitals and the field as well as by
patients at home.
Our technologies are concerned with a wide variety
of clinical areas, such as diabetes, HIV, hepatitis, and sexually
transmitted diseases such as chlamydia and gonorrhoea. Roche Diagnostics
is also pioneering new diagnostic techniques which, for example,
screen for problems at a molecular level. This has helped Roche
Diagnostics develop a leading DNA-based diagnostics technology
that has been invaluable in enhancing diagnosis and monitoring
of diseases such as AIDS and hepatitis.
The development of new diagnostic technologies
is driven by very pragmatic reasons that have a direct impact
on how effective the UK can be in fighting infectious diseases.
New diagnostic technologies can:
(a) Allow infections to be diagnosed more
accurately. A number of infections can present observable symptoms
that could point to a variety of ailments or diseases. A primary
value of new diagnostics is that they enable a clearer, more definitive
conclusion to be drawn on what is wrong with a patient so that
effective clinical interventions can be started.
(b) Allow earlier diagnosis of infections.
Some infectious diseases do not exhibit their classic symptoms
in the early stages of infection. Alternatively, observable symptoms
may be fleeting or difficult to detect. Modern diagnostics, which
are designed to be more sensitive than previous technologies,
have increased sensitivity, which allows the detection of infections
at earlier stages.
(c) Help manage the spread of infection.
Isolation can be an effective (albeit extreme) means of containing
infection. Early and accurate diagnosis, as set out above, is
essential if this strategy is to be employed quickly enough to
have maximum effect. Similarly, vaccination may be appropriate
in certain instancesand better diagnosis may be useful
in determining which populations need to receive this type of
(d) Reduce ongoing treatment costs. Modern
health interventions are often expensive. Resources are also limited
by necessity. Investment in diagnosis can be invaluable in reducing
ongoing treatment costsparticularly if new technologies
reduce long term complications which in themselves may be very
expensive to treat. (This also, of course, has significant quality
of life benefits for affected patients.) Costs are also reduced
as it will reduce wastage of inappropriate prescribing and other
(e) Facilitate superior care/better patient
outcomes. Fundamental to the value of new technologies are the
better outcomes they can help deliver for patients. Apart from
enhancing the overall impact of a clinical intervention, they
may also be preferable for the patient if they are less invasive,
more certain or more quick to deliver a definitive result. These
benefits should not be underestimated. Awaiting, for example,
the result of an HIV diagnosis is a stressful and unpleasant situation.
Delivering certainty through early and quick results is a distinct
New technologies, even when they provide demonstrable
benefits over previous methods, can nevertheless take a long time
to be taken up by healthcare professionals. The specific reasons
why individual products are not adopted are various. However,
it is possible to categorise a few broad themes that will inhibit
the take-up of new diagnostic technologies:
(a) Cost. New diagnostics, with enhanced
capabilities, may be more expensive than current technologies.
This reflects their development and licensing costs as well as
the fact that initial levels of market penetration increase unit
costs of production. Purchasers may be reluctant to invest in
more expensive technologies until they have a clearer view of
the benefits that replacement technologies can deliver. However,
where cost savings of more effective diagnosis are not realised
by the direct purchaser, higher costs may be a drag factor. NB:
This issue can relate less to clinical judgement than the purchasing
processes that make particular technologies available to doctors,
nurses, technicians etc. In some circumstances it is not just
the tests themselves that are expensive. There may also be costs
involved in acquiring processing equipment.
(b) Clinical Confidence. In some circumstances
clinicians may be confident in existing technologies. Best practice,
particularly in treating particular infections that are infrequently
encountered, often take some time to spread within the health
community. This in part reflects the vast amounts of information
that clinicians are expected to absorb about new technologies
and practice. If one technology has proven reliable, in the absence
of the opportunity to be fully informed about new technologies
(including their strengths and weaknesses) an understandably conservative
reaction may be to use tried and tested methodology.
(c) Training. Modern diagnostics, their processing
and interpretation can be complex. A challenge of developing new
technology is to make administering the test itself as foolproof
as possible. It is also necessary to make the processing of the
test and the indicator of the result as clear and unambiguous
as possible. Nevertheless, the introduction of sophisticated diagnostics
does sometimes need to be supported by training for those delivering,
processing and interpreting results. This is itself time consuming
and busy professionals may not have the time to undertake the
(d) Awareness. Medical technology is advancing
in a myriad of fields simultaneously. It is a challenge for clinicians
to keep up with the sheer number of issues raised by the introduction
of new technology (in addition to other issues, such as evolving
care standards and other aspects of best practice). Clinicians,
particularly those not specialising in infectious disease issues,
may simply not have the time to make themselves aware of the opportunities
offered by new technology.
Many of the themes outlined above are illustrated
by the example of the take up of new Chlamyida diagnostics.
Chlamydia trachomatis is a sexually transmitted
disease that is becoming increasingly widespread in the UK. It
is difficult to detect by observation but, if left untreated,
can cause pelvic inflammatory disease, which can lead to infertility
in women and ectopic pregnancy. The fact that it can have no obvious
symptoms is one factor contributing to its spread throughout the
sexually active populationnotably including women under
25. Nine per cent of sexually active women are likely to be infected
in the UK. This is a serious health issue that could be more effectively
addressed with new diagnostic technologies.
Many laboratories still use antibody tests to
diagnose Chlamydia. These reply on the detection of antibodies
and demonstrate sensitivity as low as 50 per cent. In other words,
antibody tests can miss up to half the cases of Chlamydia.
However, new methods using more up to date technology
offer far more effective diagnostic tools. Roche Diagnostics has
developed a Chlamydia diagnostic using Polymerase Chain Reaction
(PCR) technology. PCR is a molecular biology technique that allows
for quick replication of DNA. With PCR, minute quantities of genetic
material can be amplified millions of times within a few hours
allowing for the rapid and reliable detection of genetic markers
of infectious diseases, cancer and genetic disordersincluding
PCR-based tests have several advantages over
traditional antibody-based diagnostic methods that measure the
body's immune response to a pathogen. In particular, PCR-based
tests are able to detect the presence of pathogenic agents earlier
than antibody-based methods, as patients can take weeks to develop
antibodies against an infectious agent. Earlier detection of infection
means earlier treatment, a quicker return to good health, a lower
probability of complications and less chance of infection being
PCR diagnostics for Chlamydia have demonstrated
sensitivity as high as 98 per cent, ie an extremely low number
of false test results. Laboratories using older, inferior technology
are far less likely to spot this infection. Unfortunately, despite
the serious health risks posed by Chlamydia and the increasing
prevalence of the disease, new, more effective tests are not being
taken up. Apart from individual problems this may cause it is
also contributing to the high and growing levels of infection,
with all its concomitant complications.
Failures with the take-up of new Chlamydia diagnostics
highlight the general difficulty with the adoption of new technologies.
Cost is typically stated as a barrier to change. This is despite
clear evidence that more accurate diagnosis saves more than the
cost of introducing new technology. (Paavonen, J et al. Cost-benefit
analysis of first-void urine chlamydia trachomatis screening programme.
Obstetrics & Gynaecology 1998; Volume 2, Issue 2: 292-298.)
The overall cost benefits are clear but this
is not always recognised by quick and widespread take-up of new
technology. Other contributing factors may include the lack of
co-ordinated budgeting, if those involved in initial diagnosis
are unlikely to be responsible for the costs of treating complications.
Awareness and the capacity of labs to use the new technology may
well also play their part. However, cost is a key issue.
The Government does recognise in principle that
better diagnosis and pathology is important in dealing with infectious
disease. The Department of Health has stated:
"Pathology is essential for effective diagnosis
with some 60 per cent of diagnosis based on pathology. It underpins
delivery of NHS priorities and is essential in delivering fast
and accurate diagnoses and effective medication for patients.
The NHS Plan depends on pathology services, especially for cancer,
A & E and waiting times targets.
The PMP is part of the broader Modernising Government
programme, and is a key part of NHS modernisation, supporting
delivery of NHS Plan targets, the National Cancer Plan and also
National Service Framework (NSF) targets, through innovation and
redesign across acute and primary care." (Source: www.doh.gov.uk/pathologymodernisation)
However, more has to be done in practical terms
to ensure that new technologies are adopted across the health
serviceso that their full patient and systemic benefits
can be delivered.
Dedicated funding and budget co-ordination:
Budget allocation and assessment should ensure that diagnostics
are given sufficient priority. Ideally this process would be primed
by developing pilots with dedicated diagnostic budgets to provide
compelling evidence of systemic benefits of introducing new technologies.
It is important that increasing the priority
of diagnostics and ensuring the beneficial impact of their use
are well understood.
Training and awareness: Technicians and clinicians
should have diagnostic issues prioritised within their obligations
for continuing professional development. They should also be given
the opportunity to familiarise themselves with newly available
technologies. Strategic Health Authorities/PCTs or Trusts might
also establish regular seminars for both clinicians and budget
holders to attend. NB: Both managers and those involved in the
delivery of front line services need to be involved if technologies
are to be adopted effectively.
Best practice co-ordination: Effective take-up
of new diagnostic technologies should be assessed to see if local
practice could be spread more widely. This should consider the
local adoption of specific technologies and where lessons from
the take-up of a particular diagnostic can be applied in other
areas. The objective should be to establish a co-ordinated process
for the introduction of new technology in the UK.
Roche Diagnostics hopes that this brief exploration
of issues relating to the take-up of new diagnostic technologies
is helpful. We would be pleased to provide more information on
the points raised in this paperparticularly on Chlamydia
or other specific diagnostic technologies.
Please do not hesitate to get in touch if we
can provide any more assistance.