Companion Diagnostics Are Becoming an Integral Part of the Design and Development of Targeted Cancer Therapies.DUBLIN, Ireland -- Research and Markets (http://www.researchandmarkets.com/reports/c44587) has announced the addition of Companion Diagnostics: Enabling Personalized Medicines in Cancer to their offering. Companion diagnostics will play an increasing role in cancer care. Pharmaceutical companies developing targeted therapies for cancer must consider the potential benefits of developing a companion diagnostic. As they join the rush to identify critical biomarkers, however, they also need to consider technology options, potential diagnostics partners, and regulatory hurdles. Get the Answers You Need to Shape Your Strategy Companion diagnostics are becoming an integral part of the design and development of targeted cancer therapies. How can pharmaceutical companies identify which agents need to be developed in concert with a companion diagnostic and which do not? Is the inevitable stratification of disease markets a reason to shy away from Verb 1. shy away from - avoid having to deal with some unpleasant task; "I shy away from this task" avoid - stay clear from; keep away from; keep out of the way of someone or something; "Her former friends now avoid her" targeted therapies and companion diagnostics? Developing targeted therapies and companion diagnostics is all about discovering and validating clinical biomarkers. Which diagnostics companies are developing biomarkers that might be potential targets for licensing or acquisition? PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) , microarrays, and expression profiling are being used to improve the sensitivity and selectivity of companion diagnostics. Which companies are developing key technologies? What are the latest developments in this field? Many companies forego FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approval and instead develop companion diagnostics for use in CLIA-certified laboratories. What are the advantages of going the CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a route? Are all companion diagnostics likely to need FDA approval in the near term? Scope - Regulatory issues: CLIA regulations, FDA guidance on pharmacogenetic tests, and the Health and Human Services Noun 1. Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Department of Health and Human Services, HHS Secretary's Advisory Committee on Genetics, Health, and Society. - Companion diagnostics available for current products: Herceptin, Gleevec, EGFR EGFR Epidermal Growth Factor Receptor (a kinase enzyme) EGFR Estimated Glomerular Filtration Rate , metabolizing enzymes. - Companion diagnostics for CLIA labs: leading companies and products. - Emerging technologies and products: review of technologies used for design of companion diagnostics, epigenetics, blood-based technologies, oncology biomarkers. - Leading companies: profiles of select companies developing companion diagnostics. - Outlook: a look ahead to the role companion diagnostics may play in drug development. - Spectrum Expert Commentary: the view from an executive at an industry-leading company. Content Outline: Executive Summary Strategic Considerations Stakeholder Implications Targeted Therapies and Companion Diagnostics Regulatory Quagmire Scope of Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. Regulations FDA Guidance for Pharmacogenetic Tests and Genetic Tests for Heritable her·i·ta·ble adj. 1. Capable of being passed from one generation to the next; hereditary. 2. Capable of inheriting or taking by inheritance. Markers Secretary's Advisory Committee on Genetics, Health, and Society Spectrum Expert Commentary: Regulatory Approaches to Companion Diagnostics Companion Diagnostics on the Market Herceptin (Trastuzumab) Companions Gleevec (Imatinib) Companions Epidermal Growth Factor Receptor This article is about a cell suface receptor. For estimated measure of kidney function (eGFR), see Glomerular filtration rate. The epidermal growth factor receptor Companions Companion Diagnostics Involving Metabolizing Enzymes Companions for TMPT TMPT Thiopurine Methyltransferase TMPT Taylor Made Properties Turkey TMPT Tactical Marine Petroleum Terminal , CYP CYP In currencies, this is the abbreviation for the Cyprus Pound. Notes: The currency market, also known as the Foreign Exchange market, is the largest financial market in the world, with a daily average volume of over US $1 trillion. 2C9, and UGT1A1 Enzymes Companions for Aromatase Inhibitors Companion Diagnostics Used by Clinical Service Laboratories New Technologies and Products Under Development Epigenetic-Based Companion Diagnostics Epigenomics Oncomethylome Orion Genomics Rubicon Genetics Blood-Based Technologies Oncology Biomarkers Throughout a Drug's Life Cycle Select Companies Developing Companion Diagnostics Molecular Profiling Institute Monogram Biosciences Oxford Genome Sciences Target Discovery Outlook Tables Figures Companies and Products Mentioned - 20/20 GeneSystems - Abbott Molecular - Affymetrix - Agendia - AmeriPath - Amgen/Abgenix's panitumumab - Asterand - AstraZeneca's Arimidex (anastrozole), - Iressa (gefitinib), Nolvadex (tamoxifen tamoxifen (təmŏk`sĭfĕn'), synthetic hormone used in the treatment of breast cancer. Introduced in 1978, tamoxifen is used to prevent recurrences of cancer in women who have already undergone surgery to remove their tumors. ), - Zactima (ZD-6474) - Bayer Healthcare Diagnostics Division - Bayer's Advia Centaur HER2/neu assay, - Nexavar (sorafenib) - Berlex's Campath (alemtuzumab) - BioGenex's InSite ER/PR, InSite HER2/ - neu kit - Biosite - Bristol-Myers Squibb's Coumadin (warfarin warfarin (wôr`fərĭn), anticoagulant used to treat blood clots. In large doses it causes bleeding. Warfarin, mixed with bait, is used in rodent control. warfarin Anticoagulant drug, marketed as Coumadin. ) - Bristol-Myers Squibb/ImClone/Merck - KGaA's Erbitux (cetuximab) - DakoCytomation's c-Kit pharmDx, EGFR - pharmDx, ER/PR pharmDx, HER2 FISH - pharmDx kit, HercepTest - DxS's EGFR Mutation Test Kit, T790M - EGFR Mutation Test Kit - Epigenomics - Genentech/OSI's Tarceva (erlotinib) - Genentech/Roche's Omnitarg - (pertuzumab, R-1273) - Genentech/Roche/Chugai's Avastin (bevacizumab), Herceptin (trastuzumab), - Rituxan/MabThera (rituximab) - GE Healthcare - Genmab's HuMax-EGFr (zalutumumab) - Genomic Health's OncotypeDx - Genzyme Genetics' BCR-ABL mutation - analysis, EGFR by FISH, EGFR mutation - assay, FLT3 mutation analysis, JAK2 test, - p53 mutation analysis, WT1 RQ-PCR - GlaxoSmithKline's Tykerb (lapatinib) - IBM Life Sciences Division - Iceland Genomics - International Genomics Consortium - Johnson & Johnson Pharmaceutical - Research & Development - Kosan Biosciences epothilone D (R-1645) - Eli Lilly - Molecular Profi ling's MammaPrint, - Personalized Medicine Expert System (PerMedEx) - Monogram Biosciences (ViroLogic) - Nanobiomics - Novartis's Gleevec (imatinib), Femara (letrozole) - Oncogene oncogene Gene that can cause cancer. It is a sequence of DNA that has been altered or mutated from its original form, the proto-oncogene (see mutation). Proto-oncogenes promote the specialization and division of normal cells. Sciences - Oncomethylome - Orion Genomics - Oxford Genome Sciences - Pfizer's Aromasin (exemestane), - Camptosar (irinotecan), Sutent (sunitinib) - Phillip Morris Research Laboratories - Prometheus Laboratories' Imuran (azathioprine azathioprine: see metabolite. ), PRO-PredictRx TPMT TPMT Thiopurine Methyltransferase TPMT Transaction Processing Monitor Technology TPMT Total Preventive Maintenance Time - Response Genetics - Roche's AmpliChip Cytochrome P450 - Genotyping test, AmpliChip Leukemia - Test, AmpliChip p53, R-547, ocrelizumab (R-1594), R-1530, epothilone D (R1492), - Xeloda (capecitabine) - Rubicon Genomics - Schering-Plough's Temodar (temozolomide) - Target Discovery - Third Wave Technologies' Invader - UGT1A1 Molecular Assay - Translational Genomics Research - Institute - US Oncology - Ventana Pathway Anti-c-Kit, Pathway - HER2/neu - Vysis/Abbott's PathVysion HER2 DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. - Wako LBA AFP-L3 - Weisenthal Cancer Group's EGFRx-assay - Wellcome Trust Center Institute - YM BioSciences' TheraCIM hR3 (nimotuzumab) For more information visit http://www.researchandmarkets.com/reports/c44587 Source: Decision Resources |
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