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PUBLISHER: Greystone Research Associates | PRODUCT CODE: 1186911

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PUBLISHER: Greystone Research Associates | PRODUCT CODE: 1186911

Pharmacogenomic Biomarkers in Precision Medicine: Generic Variations in Drug Response

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PAGES: 102 Pages
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Introduction

Visual Therapeutics is pleased to announce the publication of a new life science information resource. Pharmacogenomic studies conducted in recent decades have provided an over whelming amount of evidence regarding the influence of inter-individual genetic variations on drug response. As genotyping technology becomes more advanced, cost-effective, and widely accessible, data from future studies will undoubtedly reveal many more important gene-drug associations. Once the clinical utility of predictive pharmacogenetic testing becomes more widely established, genotyping is expected to be an indispensable tool in predicting and improving drug response, with the ultimate goal of personalizing patient drug treatment to provide better therapeutic outcomes.

Generating Product Improvements Using Genomic Markers

Severe adverse drug reactions are one of the most common reasons for hospital admissions in the U.S. Adverse drug reactions rank as the fourth leading cause of death in the U.S. and are responsible for 100,000 deaths annually. Genetic testing for drug response is expected to reduce the risk of hospitalization by as much as 30%. To this end, multidisciplinary teams of laboratory, clinical, and computational researchers are working together to personalize drug treatment by incorporating an individual's genetic information (both germline and somatic) into existing prescribing models. A patient's genome needs to be identified only once in a lifetime, which makes pharmacogenetic screening a potentially very potent, cost-effective diagnostic tool evolving and highly unpredictable environment that has been a challenge to decision makers attempting to map strategies for success in this segment. There are 600 distinct APIs for which there is at least one approved generic solid dosage form ANDA. These APIs account for over four thousand approved ANDAs. Including all approved doses, the current universe of generic solid dosage forms consists of thousands of unique tablet and capsule products. These products are marketed and supplied by more than 800 companies. Competition among the various drug and therapeutic classes is uneven, with the top ten segments accounting for a disproportionate level of activity and revenue. Understanding the underlying factors affecting business performance is key to attaining financial targets.

Detecting and Measuring Biomarkers

Several companies manufacture FDA-approved pharmacogenetic screening tests. The first test of this type available for clinical use was the AmpliChip CYP450, which was introduced to the market in 2005. This test identifies CYP2D6 and CYP2C19 variants that code for DMEs and predict whether a patient exhibits a PM, IM, EM, or UM phenotype.

This information helps to characterize how an individual will metabolize approximately 25% of prescribed drugs. Another available test is the Affymetrix DMET (DMEs and transporters) chip. This product evaluates polymorphisms in CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, A5, and A7 genes.

Detecting and Measuring Biomarkers

Several companies manufacture FDA-approved pharmacogenetic screening tests. The first test of this type available for clinical use was the AmpliChip CYP450, which was introduced to the market in 2005. This test identifies CYP2D6 and CYP2C19 variants that code for DMEs and predict whether a patient exhibits a PM, IM, EM, or UM phenotype.

SAMPLE VIEW

This information helps to characterize how an individual will metabolize approximately 25% of prescribed drugs. Another available test is the Affymetrix DMET (DMEs and transporters) chip. This product evaluates polymorphisms in CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4, A5, and A7 genes.

Biomarkers and Disease Associations

Pharmacogenomic Biomarkers have been identified for a dozen disease conditions. Almost half of all biomarker associations identified to date are for Oncology indications. Cancers are followed by Neurology, Psychiatry and Infectious Diseases.

SAMPLE VIEW

Table of Contents

  • Executive Summary
  • Point-of-Care Diagnostics Market Dynamics
  • Biomarkers and their Potential in Clinical Medicine
  • Electrochemical Sensing Methods
  • Optical Sensing Methods
  • Chronic Disease Associated Biomarkers
  • Biomarker Detection
  • Chronic Disease Biomarkers
  • Opportunities Extend Across Numerous Therapeutic Areas
  • Anesthesiology
  • Cardiology
  • Endocrinology
  • Gastroenterology
  • Gynecology
  • Hematology
  • Inborn Errors of Metabolism
  • Infectious Diseases
  • Neurology
  • Oncology
  • Rheumatology
  • Microneedle Biomarker Diagnostics
  • Key Therapeutic Sectors
  • Glucose
  • Immune Factors
  • Electrolytes/Potassium
  • Biomarker-enabled Diagnostics
  • Drug/Biomarker Disease Association
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Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

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