The goal of pharmacogenomics is individualized medicine, the scientific area that combines the disciplines of pharmacy, pharmaceutical sciences and genetics. It provides data that can be used to define differences between healthy and diseased tissues at the molecular or gene expression level with annotated knowledge of genes as single nucleotide polymorphisms (DNA) and gene expression (RNA) as well as proteins. See Genes and Disease below. Pharmacogenomics applies genetic information to the development of new, more specific and effective drugs and molecular diagnostics. As the market continues to grow in the area of molecular diagnostics (tests using DNA, RNA or protein) it is critical to have the ability to determine gene expression patterns (from RNA) more reliable, reproducible and accurate. Until StaRT-PCR the market has been challenged with finding technologies that can determine gene expression patterns of absolute precision and to generate data of the highest quality. The ability to have true numerical values from StaRT-PCR allows the data to remain alive and create standardized databases. This standardized data is not only critical for application to drug development, theranostic, prognostic, clinical biomarkers and molecular diagnostic products but will enhance our understanding of various disease processes. The StaRT-PCR provides researchers the tools and technology to develop clinically validated biomarker assays and Interactive Transcript Abundance Indices (ITAIs). Gene Express technical expertise will assist you in achieving your pharmacogenomics goals.

The development of new molecular genetic tests will help to determine which individuals will most likely respond to any one particular drug. Theranostics describes the use of diagnostic testing to diagnose the disease, to choose the correct treatment regime and monitor the patient response to therapy. This is the movement toward what is known as personalized medicine. This will not only allow pharmaceutical companies to develop more effective drugs, but will aid in identifying those individuals for which any one drug will be most effective (or not effective at all). Gene Express, Inc. is proud to contribute to achieving the goal of personalized medicine with the use of our StaRT-PCR Technology and our Molecular Diagnostics Products.

Gene Express Consulting Services Utilizing StaRT-PCR which is a quantitative, standardized multi-gene expression method that meets the new regulatory guidelines provides the necessary technology to create successful outcomes. The use of Standardized Mixtures of Internal Standards (SMIS) provides the quality control that is required. StaRT-PCR provides standardized numerical gene expression values to associate transcript profiles with phenotypes. The StaRT-PCR Method provides researchers the tools and technology to develop clinically validated biomarker assays and Interactive Transcript Abundance Indices (ITAIs). See StaRT-PCR and Pharmacogenomics below.

Gene Express technical expertise will assist your company and you in achieving your pharmacogenomics goals in a variety of ways:

Genes and Disease Today in pharmaceutical sciences and health care, we are rapidly integrating genomic research with StaRT-PCR data into tools like Interactive Transcript Abundance Indices to better assess risk, make earlier diagnoses, and individualize treatment of diseases and conditions.

The following list helps explain several important concepts relating to genes and disease.

StaRT-PCR and Pharmacogenomics The goal of pharmacogenomics is individualized medicine, the scientific area that combines the disciplines of pharmacy, pharmaceutical sciences and genetics. The term comes from the words pharmacology and genomics and is thus the intersection of pharmaceuticals and genetics. Pharmacogenomics holds the promise that drugs might one day be tailor-made for individuals and adapted to each person's own genetic makeup. Environment, diet, age, lifestyle, and state of health all can influence a person's response to medicines, but understanding an individual's genetic makeup is thought to be the key to creating personalized drugs with greater efficacy and safety. Pharmacogenomics provides data that can be used to define differences between healthy and diseased tissues at the molecular or gene expression level with annotated knowledge of genes as single nucleotide polymorphisms (DNA) and gene expression (RNA) as well as proteins. Pharmacogenomics applies genetic information to the development of new, more specific and effective drugs and molecular diagnostics. As the market continues to grow in the area of molecular diagnostics (tests using DNA, RNA or protein) it is critical to have the ability to determine gene expression patterns (from RNA) reliably, accurately and with reproducibility.  Until StaRT-PCR, it was a challenge in the market to find technologies that could determine gene expression patterns and generate data with high quality and absolute precision.  The ability to have true numerical values from StaRT-PCR allows the data to remain alive and create standardized databases. This standardized data is not only critical for application to drug development, theranostic, prognostic, clinical biomarkers and molecular diagnostic products but will enhance our understanding of various disease processes. The StaRT-PCR technology provides researchers the tools and technology to develop clinically validated biomarker assays and Interactive Transcript Abundance Indices (ITAIs).

Personalized Medicine - With the advent of the genomic revolution, scientists are avidly seeking correlations between human disease and the architecture of individual genes. Parsing this huge amount of data could eventually lead to "personalized medicine," some researchers say, allowing doctors to prescribe the right drug at the right dose for the right person, based on unique variations in their DNA and the environment of there life. Pharmacogenomics is the study of how an individual's genetic inheritance and their life's environment affect the body's response to drugs.

The field of pharmacogenomics focuses on two broad areas. The first area encompasses molecular genetics to identify better, more specific drug targets at the molecular level. Secondly, specific genetic tests are developed to determine the genetic background relative to the disease and drug or drugs available to treat the disease. Through continued, dedicated activity in these areas, the industry will develop more effective and safer drugs, a more efficient and less costly drug development process (cost effective drugs for the consumer), and more rational use of drugs. Through pharmacogenomics, researchers hope to avoid toxicity problems often associated with drugs and to alleviate failure of drugs in the later stages of development.

The first step in facilitating the success of pharmacogenomics has moved forward the entire DNA sequence of the human genome has been completed through the efforts of the Human Genome Project and private companies. The next step for the pharmacogenomic paradigm is to determine what genes are responsible for what physiological and/or pathophysiological processes. There here has been significant progress in this area. One of the most fruitful approaches is the measurement of gene expression in cells and tissues (often referred to as expression profiling). Gene expression measurement allows scientists to determine which genes are expressed and to what degree. This provides data that can be used to define differences between healthy and diseased tissues at the molecular or gene expression level.

StaRT-PCR is a necessary technology to assist the pharmacogenomics paradigm and personalized medicine in becoming a true reality. The ability to just understand the molecular basis of the disease is not enough. It is critical to understand how it can be applied clinically. The technologies used today and in the future must be precise and provide the highest level of quality. Gene Express and its StaRT-PCR technology delivers on both The use of Standardized Mixtures of Internal Standards (SMIS) allows scientists to obtain standardized, quantitative, multi-gene Transcript Abundance data. This standardized data is not only critical for application to drug development, theranostic, prognostic, clinical biomarkers and molecular diagnostic products but will enhance our understanding of various disease processes. By incorporating StaRT-PCR gene expression or Transcript Abundance data into a data bank, the data remains alive. Results can be compared readily between experiments. Relationships between gene expression levels and phenotype will be discovered much faster than has been experienced. Interactive Transcript Abundance Indices (ITAIs) can be defined because the data values are numerical and can be manipulated mathematically. In addition, standardized, quantitative, numerical values will allow scientists to define "normal" levels of gene expression for many genes. All of these characteristics of StaRT-PCR make it an ideal gene expression technology to apply to pharmacogenomics.

Further Reading:

For more information regarding the field of Pharmacogenomics, visit the following websites:

My DNA

Pharmacogenomics: Medicine and the New Genetics

Human Genome Project link

ONE SIZE DOES NOT FIT ALL: THE PROMISE OF PHARMACOGENOMICS

The New, New Pharmacogenomics

Benefits of Pharmacogenomics from the AMA website