By Dr Farhana Fiona Rahman, Programme Leader- Clinical Diagnostics - Healthcare, Frost & Sullivan

Medical communities have laid emphasis on preventive medicine as the most efficacious and cost effective approach to improve the quality of life. In addition, researchers have realised that the most advantageous way to combat many diseases such as diabetes or cancer is to predict susceptibility and begin preventive treatment before the onset of the disease. Designing preventive screening tests will allow people to be in charge of their own health. Therefore, pharmacogenomic testing has tremendous market value.

Pharmacogenomic testing throughout Europe is initiated by physicians, which involves referring a patient to a specialist such as a clinical geneticist or other consultant. After discussions with the patient, the pharmacogenomics is performed. Nowadays, as the technology of personalised medicine has become inexpensive and more readily available, the European public have radically changed the current emphasis on disease management uniformity, focussing more on individual patient management. These tests can be used to predict the chances of a disease developing, so appropriate preventive action can be taken, while providing information for peace-of-mind, prevention, treatment and healing as the process involves the studying of how medicines work in the body and genetics. Pharmacogenomics provides the opportunity to manufacture customised drugs for patients, suitable for each person's individual genetic make-up. A number of factors such as the environment, lifestyle, diet and age all can influence a person's response to medicines, but determining an individual's genetic make-up is fundamental for creating personalised drugs with greater efficacy and safety.

Pharmacogenomic companies help pharmaceutical companies identify and use genotypes to recruit high responders for clinical trials. They are most useful in determining subsets of patients who may benefit from a drug or for helping pharmaceutical companies better define and expand markets for existing products. Healthcare providers will need a deliberate push to adopt pharmacogenomic testing as part of the drug treatment process. Moreover, for pharmacogenomic testing to become more prevalent, large pharmaceutical companies will need to change their blockbuster mentality and incorporate pharmacogenomic data into the drug development process.

Pharmacogenomic diagnostic tests contribute to the therapeutic productivity, which can be evaluated on four criteria: number of resulting drugs, revenue potential, time saved and cost-to-return ratios. By combining diagnosis of the disease and drug development, pharmacogenomics holds great potential in all four metrics. Feedback has suggested that the use of genetic markers associated with specific conditions, are anticipated to determine targets for drugs or therapies to cure diseases. Frost & Sullivan believe that diagnostics and therapeutics are possibly being lined up to deliver improved patients care solutions, as pharmacogenimics will play a significant role in identifying and validating drug development targets. The use of pharmacogenomic diagnostics will complement the development of a drug's performance in clinical trials, reducing product failures and encouraging more immediate application.

Although the awareness levels are increasing, the translation of pharmacogenomics tests into routine clinical practice to more effectively select patients for treatment, monitor drug efficacy or avoid adverse events have been slow. Pharmaceutical companies are less cautious towards these tests, as it could result in a reduction of the commercial value for their drugs. These companies are yet to develop their knowledge in development, manufacturing and regulatory steps required for a diagnostic product to be commercialised. Additionally, the lack of familiarity of these pharmaceutical companies to different customer-bases for the products augments the whole situation.

Therefore, partnerships between pharmaceutical and diagnostics companies can provide a win-win combination for both parties involved. Although the major in-vitro diagnostics (IVD) participants such as Roche Diagnostics, Abbott Diagnostics and Bayer Corporation have major shares in both businesses, they should endeavour to capitalise their strengths for market expansion.

European governments are improving the access of genetic services to patients and healthcare professionals within the context of primary care through service provision, education and liaison. It is imperative that physicians provide an initial referral and management route for adults with history of cancer, and offer advice and support for primary care healthcare professionals and hospitals involved in the provision of genetic services, with a view to improve access to patients to appropriate diagnosis.

However, concerns have risen with the possibility in some cases leading to the misuse or reuse of genetic information for various purposes by the organisations or by third parties. There are risks of misuse of the actual genetic information and the underlying material, for example, blood samples which have the chance to be misused by being subjected to additional analyses. There is the risk of disclosing an individual's genetic data to others without that individual's approval, therefore private genetic information should not be collected, held or communicated without the individual's expressed consent, obtained prior to performing the test. For example, in certain parts of Europe such as the Netherlands, individuals that desire pharmacogenomic testing are required to sign agreements stating that the DNA information belongs solely to them and they have wholly consented to participating in the test.

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