March 2009 392

Molecular Diagnostics Point-of-Care (POC) Infectious Disease Test- Market Insight, Healthcare Practice, Frost & Sullivan

At present, polymerase chain reaction (PCR) testing predominates; however, alternative technologies aimed at reducing genome complexity without PCR are anticipated to gain momentum in the coming years.

The In Vitro Diagnostics (IVD) industry is one of the most lucrative segments in the global healthcare industry, driven by factors such as increasing prevalence of several chronic and infectious diseases, emerging technologies, and increasing patient awareness. The IVD market is particularly characterised by the emergence of various novel technologies with molecular diagnostics and point-of-care (POC) tests expected to play a very important role in driving the future growth of the industry.

Currently, the consumer self-testing market is by far the largest segment of the POC diagnostics market, and mainly comprises blood glucose testing and pregnancy testing.

Fuelled by an ageing population and obesity, the number of people with diabetes is rising worldwide and it is now the fourth leading cause of death in most developed countries.

Beyond blood glucose monitoring Frost and Sullivan believes the fastest growing segments in the POC testing market are infectious disease and cardiac testing, especially the need for coagulation treatment and monitoring owing to the increased number of tests available and greater demand for such tests.

The infectious disease testing market is primarily being driven by the increasing incidence of certain diseases, including viral hepatitis, respiratory syncytial virus (RSV), influenza, tuberculosis, HIV and other STDs, as well as the rapid rise in hospital-acquired infections (HAIs).

The POC infectious disease market in Europe was worth USD 40.0 million in 2008 but is expected to grow at 4.9% CAGR, hitting USD 56.1 million by 2015. Recent discoveries and innovations in the realm of molecular diagnostics hold the exciting promise of revolutionising the healthcare area. In particular, the evolution of POC testing expects to have a significant impact on patient care management. Additionally, public awareness initiatives and governmental campaigns across Europe are facilitating the uptake of new technologies and highlighting the value of POC molecular diagnostic for the improvement of medical care reducing the overall healthcare cost.

Many argue the accuracy and quality of the POC tests in relation to laboratory molecular tests. However, in most cases pure clinical diagnosis has been reported to be lower than 50% accurate. Using POC tests in hospital settings have shown to bring more benefits than tests like PCR, especially in the diagnosis of a common cold or influenza. To run a PCR test would take about five hours, meaning that patients suffering from influenza are not treated straight away, thus increasing the chances of infection and spread. If the physician is uncertain about the diagnosis, he or she may run numerous tests that can be expensive. Frost and Sullivan believes much more support should be given to physicians and nurses, with training programmes set in place to change the mindset of the healthcare management. In 2008, Group A streptococcus A accounted for 40.9% of the revenues generated by the POC infectious disease market followed by C-restrictive proteins (CRP) 29.8%. CRP analysis has grown to be a useful test for supporting the diagnosis of infections and has proven to be a valuable tool in differential diagnosis, for example, distinguishing between bacterial and viral infections.

“As part of patient care, physicians within the Scandinavian countries have started to use the CRP and Strep A POC tests to distinguish between common cold and influenza patients. If the levels of CRP are high, that is the cause of bacterial infection, therefore introducing the need for strep A tests. Strep A Test Strip detects the presence of Strep A antigen in throat swab specimens providing results within five minutes and a sensitivity of 97 per cent compared to culture” noted a spokesperson of POC tests, Germany.

The high prevalence of asymptomatic Chlamydia and gonorrhoea infections is one of the greatest obstacles to STD control. A widely available diagnosis test  which allows prompt and effective treatment of asymptomatic patients could reduce the prevalence of these infections, preventing complications and reducing the transmission of HIV infection. Frost and Sullivan believes that when calculating the number of patients brought to treatment, rapid tests have a distinct advantage. In most healthcare settings, some patients do not return for the results of laboratory tests. The advantage of POC tests is that they can enable treatment to be given on the spot rather than hoping that the patient will return for treatment. However, there still are concerns over the sensitivity and specificity of POC tests for detecting HIV or STDs since they are asymptomatic and therefore cannot be confirmed

immediately. There are discussions over running PCR screens under such cases. In addition, despite technological advances enabling the continued development of POC tests, the use of POC tests presents many challenges for the sexual health services. It questions existing approaches to service delivery � for example, finger-stick testing for HIV raises questions about conventional counselling before and after testing. These challenges seem daunting. However, Frost and Sullivan believes that it should not come in the way of maximising the use of POCT where appropriate.

Novel platform technologies and key advances in genomics are rapidly driving the development of molecular diagnostics. In the coming years, molecular diagnostics will continue to be of critical importance to public health worldwide. It will facilitate the detection and characterisation of disease, as well as monitoring of the drug response and will assist in the identification of genetic modifiers and disease susceptibility. A wide range of molecular based tests is available to assess DNA variation and changes in gene expression. However, there are major hurdles to overcome before the implementation of these tests in clinical laboratories, such as which test to employ, the choice of technology and equipment and issues such as cost-effectiveness, accuracy, reproducibility, personal training, reimbursement by third-party players and intellectual property. At present, polymerase chain reaction (PCR) testing predominates; however, alternative technologies aimed at reducing genome complexity without PCR are anticipated to gain momentum in the coming years. Furthermore, development of integrated chip devices (‘lab-on-a-chip’) should allow POCT and facilitate genetic readouts from single cells and molecules. Together with proteomic-based testing, these advances will improve molecular diagnostic testing and will present additional challenges for implementing such testing in healthcare settings.

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