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The latest catchphrase in the lab-medical community is personalized medicine. This new healthcare jargon is capturing the public�s imagination raising expectations for therapies that are safer, more effective, and targeted to individual health needs. Personalized medicine is a relatively new field that recognizes and takes advantage of a patient's individual genetic and physiologic make-up, as well as specific environmental influences. It has been alternately broadly and narrowly defined. Under its broadest definition, clinicians have been providing personalized medicine for as long as there has been medical practice: doctors employ diagnostic tools, whether in vitro tests, imaging techniques, or symptomatology to determine a particular condition, and then go on to prescribe the appropriate treatment, drug or otherwise.
Personalized medicine covers a wide range of topics, but it generally refers to tailoring drugs and procedures based on the genetic makeup of an individual patient. While most human genes are the same in every individual, there are quite a few that contain differences. Changes in those genes might make you more susceptible to getting a disease, or determine how you will respond to a drug. In fact, it is the �-omics�, the ability to test for variations in genes and their expression through molecular diagnostics and then to treat with targeted drugs, that shapes a narrower, and more potent, definition .The increasing interest in this field is driven by the development of a number of molecular diagnostics-based tests that determine a patient�s genetic predisposition to a given disease or to adverse drug reactions. Today, there are genetic tests clinically available for close to 1,000 diseases, and several hundred tests are in development, making genetic testing the fastest growing area of laboratory diagnostics. Genetic testing is becoming an increasing part of medical care, and is used in screening, diagnosis, treatment, and prevention. The -�omics� promise to open up a new frontier in medicine. Within the next decade, molecular diagnostic products will likely enable researchers to predict a patient's response to therapy based on the genetic makeup of a tumor (in the case of cancer), a viral genotype (for viral infections) or the genetic makeup of the patient (for a wide variety of conditions).
Conceptually, The personalized medicine is reconfiguring the research/ development as well as the business models of diagnostics and pharmaceutical companies. The diagnostic test could be considered as an increasingly valuable tool, offering both clinical and economic value to manage the appropriate use of expensive drugs avoiding expensive prescriptions for a non responder or drugs with dangerous side effects. The longer-term opportunity for these diagnostics companies will be to link test development programs to drug development programs and then launching the approved drug and test as a true tandem from the outset. A nearer-term opportunity for diagnostics companies is the development of tests that are linked to currently marketed therapies. Currently marketed drugs that could benefit from a test to identify optimal responders are near-term target markets for diagnostics companies.
For personalized medicine to work, quality genetic testing requires good tests and competent laboratories., there must be a sufficient level of confidence that the laboratories offering these tests are performing them correctly and that the tests themselves yield information that is relevant to health care decision making. A guidance on the co-development of drugs and diagnostic tests will ensure continued innovation and accelerate the translation of these products from the laboratory bench to the patient�s bedside.
As these efforts continue, It is necessary to create a innovative environment between the stakeholders biomedical and pharmaceutical companies, laboratory scientists and physicians and patients that is favorable to both the basic research that is required for innovation of effective personalized medicine solutions, as well as their eventual commercialization. The system will also require new regulatory approaches, revamped medical education curricula, integrated health information technology, strong patient privacy protections, and an insurance reimbursement system that encourages preventive medicine and supports access to the tests and treatments that enable physicians and patients to personalize care.
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