Select Committee on Science and Technology Written Evidence

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 instances—and better diagnosis may be useful in determining which populations need to receive this type of protection.

    (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 costs—particularly 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 clinical interventions.

    (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 patient benefit.


  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 required tuition.

    (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 population—notably 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 disorders—including Chlamydia.

  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 spread.

  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:

  However, more has to be done in practical terms to ensure that new technologies are adopted across the health service—so 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 paper—particularly on Chlamydia or other specific diagnostic technologies.

  Please do not hesitate to get in touch if we can provide any more assistance.

October 2002

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