The Integration of Molecular Diagnostics With Therapeutics
The Integration of Molecular Diagnostics With Therapeutics
It is widely anticipated that during the next 5 years the molecular diagnostic industry will continue to grow at double-digit pace to meet increasing demand for personalized medicine. A wide variety of drugs in late preclinical and early clinical development are being targeted to disease-specific gene and protein defects that will require coapproval of diagnostic and therapeutic products by regulatory agencies. An increasingly educated public will demand more information about their predisposition for serious diseases and how these potential illnesses can be detected in an early stage when they can be arrested or cured with new therapies custom-designed for their individual clinical status. To respond to this demand, major pharmaceutical companies will partner with diagnostics companies or develop their own in-house capabilities that will permit efficient production of more effective and less toxic integrated personalized medicine drug and test products. For clinical laboratories and pathologists, this integration of diagnostics and therapeutics represents a major new opportunity to emerge as leaders of the new medicine, guiding the selection, dosage, route of administration, and multidrug combinations and producing increased efficacy and reduced toxicity of pharmaceutical products.
Molecular pathology is in a state of rapid evolution featuring continuous technology developments and new clinical opportunities for drug selection, predicting efficacy and toxicity, and monitoring disease outcome. The approvals of trastuzumab (Herceptin, Genentech, South San Francisco, CA) for the treatment of HER-2/neu overexpressing breast cancer and imatinib (Gleevec, Novartis Pharmaceuticals, East Hanover, NJ) for the treatment of chronic myelogenous leukemia featuring a bcr/abl translocation and gastrointestinal stromal tumors with selective c-kit oncogene-activating mutations have brought to the diagnostic laboratory an expanding role for the testing of patients to determine their eligibility to receive these new therapies. The introduction of targeted therapeutics into clinical practice has created major opportunities for further development of the molecular pathology. As shown in Table 1 , the molecular diagnostics industry is a market greater than $3 billion, which currently is growing at approximately 25% per year. The worldwide pharmaceuticals annual market is estimated to exceed $1.1 trillion by 2010. It is widely held that, during the next 5 to 10 years, the clinical application of molecular pathology and molecular diagnostics will further revolutionize the drug discovery and development process; customize the selection, dosing, and route of administration of existing and new therapeutic agents; and truly personalize medical care.
Many so-called blockbuster drugs show only limited efficacy in as many as 70% of treated patients ( Table 2 ). The current roster of phenotypically derived drugs that often treat only the symptoms of diseases but do not cure them is no longer acceptable to the public. Moreover, adverse drug reactions caused by the failure to predict toxicity in individuals and toxic drug-drug interactions now account for 100,000 patient deaths, 2 million hospitalizations, and $100 billion in health care costs in the United States every year. As many as 20% to 40% of people receiving pharmaceutical agents may be receiving the wrong drug. The discovery of the human genome and the subsequent expansion of proteomics research combined with emerging technologies such as functional imaging, biosensors, and sophisticated computational biology are producing unprecedented changes in today's health care. A variety of new approaches to drug use have introduced genetically prescribed medications ( Table 3 ). Moreover, modern medicine now is driven by rapid communication and electronic information sharing, which has created more informed and demanding consumers.
It is widely anticipated that during the next 5 years the molecular diagnostic industry will continue to grow at double-digit pace to meet increasing demand for personalized medicine. A wide variety of drugs in late preclinical and early clinical development are being targeted to disease-specific gene and protein defects that will require coapproval of diagnostic and therapeutic products by regulatory agencies. An increasingly educated public will demand more information about their predisposition for serious diseases and how these potential illnesses can be detected in an early stage when they can be arrested or cured with new therapies custom-designed for their individual clinical status. To respond to this demand, major pharmaceutical companies will partner with diagnostics companies or develop their own in-house capabilities that will permit efficient production of more effective and less toxic integrated personalized medicine drug and test products. For clinical laboratories and pathologists, this integration of diagnostics and therapeutics represents a major new opportunity to emerge as leaders of the new medicine, guiding the selection, dosage, route of administration, and multidrug combinations and producing increased efficacy and reduced toxicity of pharmaceutical products.
Molecular pathology is in a state of rapid evolution featuring continuous technology developments and new clinical opportunities for drug selection, predicting efficacy and toxicity, and monitoring disease outcome. The approvals of trastuzumab (Herceptin, Genentech, South San Francisco, CA) for the treatment of HER-2/neu overexpressing breast cancer and imatinib (Gleevec, Novartis Pharmaceuticals, East Hanover, NJ) for the treatment of chronic myelogenous leukemia featuring a bcr/abl translocation and gastrointestinal stromal tumors with selective c-kit oncogene-activating mutations have brought to the diagnostic laboratory an expanding role for the testing of patients to determine their eligibility to receive these new therapies. The introduction of targeted therapeutics into clinical practice has created major opportunities for further development of the molecular pathology. As shown in Table 1 , the molecular diagnostics industry is a market greater than $3 billion, which currently is growing at approximately 25% per year. The worldwide pharmaceuticals annual market is estimated to exceed $1.1 trillion by 2010. It is widely held that, during the next 5 to 10 years, the clinical application of molecular pathology and molecular diagnostics will further revolutionize the drug discovery and development process; customize the selection, dosing, and route of administration of existing and new therapeutic agents; and truly personalize medical care.
Many so-called blockbuster drugs show only limited efficacy in as many as 70% of treated patients ( Table 2 ). The current roster of phenotypically derived drugs that often treat only the symptoms of diseases but do not cure them is no longer acceptable to the public. Moreover, adverse drug reactions caused by the failure to predict toxicity in individuals and toxic drug-drug interactions now account for 100,000 patient deaths, 2 million hospitalizations, and $100 billion in health care costs in the United States every year. As many as 20% to 40% of people receiving pharmaceutical agents may be receiving the wrong drug. The discovery of the human genome and the subsequent expansion of proteomics research combined with emerging technologies such as functional imaging, biosensors, and sophisticated computational biology are producing unprecedented changes in today's health care. A variety of new approaches to drug use have introduced genetically prescribed medications ( Table 3 ). Moreover, modern medicine now is driven by rapid communication and electronic information sharing, which has created more informed and demanding consumers.
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