Bioinformatics in IVD Testing.pdf
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1、Bioinformatics in IVD Testing 5th BIOINFORMATICSINIVDTESTING AKALORAMA INFORMATION MARKETINTELLIGENCE REPORT Bioinformatic-Based Diagnostic Tests has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of information services and research pu
2、blications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thorough presentation of essential data and concise analysis. Author: Shara Rosen Publication Date: June 2013 38 East 29th Street New York, New York 10016 (800)
3、298-5699 Outside the U.S. (212) 807-2657 FAX: (212) 807-2676 http:/www.KaloramaI E-MAIL: TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY 1? Introduction . 1? Scope and Methodology 2? Market Trends 3? IVD Markets Most Affected by Bioinformatics . 4? Advances in Lab Medicine . 6? CHAPTER TWO: INTROD
4、UCTION .9? Background . 9? Bioinformatics-based Diagnostics 9? The Case for Bioinformatics . 10? CHAPTER THREE: ENABLING TECHNOLOGIES AND COMMERCIALIZATION ARRANGEMENTS 13? Alliances and Collaborations . 14? Major Partnerships 14? Advances in Clinical Bioinformatics . 16? Reimbursement-Driven Health
5、 Data Analytics 23? Insurers, PBMs and Providers 23? The Interface and Test Technologies 27? Bioinformatics for Consumers . 29? CHAPTER FOUR: MARKET ANALYSIS BIOINFORMATICS-BASED DIAGNOSTICS33? Background . 33? The Commercial Outlook . 34? Trends In Bioinformatics-Based Tests For Cancer . 37? Techno
6、logies . 39? Tissue-based Tests 40? Blood-Based Tests . 46? Market-cleared Tests 47? Trends in Bioinformatics-based Tests for Diabetes 49? Trends in Bioinformatics-based Tests for Cardiovascular Disease 53? Trends in Bioinformatics-based Tests for Chronic Diseases 56? Arthritis . 58? Gastrointestina
7、l Conditions 61? Alzheimers Disease . 63? Parkinsons Disease 66? Psychiatric Disorders 68? Trends In Bioinformatics-Based Tests In Microbiology 72? Software Applications 75? Genome Sequencing . 77? Mass Spectrometry . 79? Trends in Bioinformatics-based Diagnostics for Prenatal Studies . 80? The Comm
8、ercial Outlook . 87? CHAPTER FIVE: CONCLUSION 91? CHAPTER SIX: IVD COMPANIES AND BIOINFORMATIC-BASED OFFERINGS .95? 23andMe . 95? Affymetrix Inc. 98? Ameritox Ltd. 100? Aperio Technologies, Inc. . 101? ArcticDx Inc. . 103? Arrayit Diagnostics Inc. 104? AssureRx Health, Inc. . 105? Atossa Genetics, I
9、nc. . 106? BG Medicine, Inc. . 107? Biodesix, Inc. 108? BioImagene 109? Bio-Reference Laboratories, Inc. (BRLI) . 111? bioTheranostics . 112? Breath Testing at Home 114? CardioDx, Inc. . 115? Childrens Hospital of Philadelphia: . 117? Chronix Biomedical Inc. . 118? CombiMatrix Molecular Diagnostics,
10、 Inc. . 119? Complete Genomics 121? Crescendo Bioscience, Inc. . 122? Dako A/S 123? deCode genetics ehf . 124? Diaxonhit Group . 126? DiaGenic ASA 127? DiaTech Oncology . 128? Duke University Medical Center . 129? Everist Genomics, Inc. (EGI) . 129? Foundation Medicine. Inc. 131? Genelex Corporation
11、 132? Genomic Health, Inc. 133? Health Discovery Corporation (HDC) 135? Inform Genomics 136? Lab21 Limited . 137? Life Technologies 138? Massachusetts Institute of Technology . 139? Mayo Medical Laboratories . 140? Medtronic Inc. . 141? Metabolon Inc. . 142? Omnyx, LLC 143? One Lambda, Inc. . 144? O
12、regon Health in fact in 2009 the American Association for Cancer Research (AACR) held its 100th annual meeting. It is a testament to the awesome complexity of this group of diseases that after 100 years, there are few (if any) cancer researchers or physicians that would claim to fully understand wha
13、t they are dealing with. What makes this health challenge so daunting is that cancer is really a collection of many rare diseases. In fact, there are no common cancers. Genetic abnormalities that cause these tumors manifest differently in each individual. Furthermore, even a healthy human body creat
14、es millions of mutations. Not all of them are relevant in disease. The diagnostic challenge is determining, for each individual, which mutations are relevant. However cancer testing is maturing and advancing from the somewhat elementary diagnostics of the 1980s and 1990s to an era of cancer medicine
15、 in the 2000s where treatment is personalized to the patient. More recently cancer researchers and oncologists refer to precision cancer technologies that work to determine the genetic and protein components of individual tumors with more precision than ever before. This more precise data are then u
16、sed to develop a tumor related treatment program. Thus we now enter the era of precision cancer medicine that partners accurate diagnosis of primary tumor site and predictive biomarkers to drive targeted therapy according to complex algorithms. Cancer continues to rank among the worlds deadliest and
17、 most costly diseases. It is the number two killer disease after cardiovascular disease, worldwide. All countries and races bear the burden of cancer. There is not one country in the world that is not affected. The highest incidences of cancer are in western countries, but so are the highest surviva
18、l rates resulting from an investment in diagnostics and treatment programs. The lowest recorded incidences of cancer are in the developing countries but they also suffered higher rates of death by cancer because they do not have adequate healthcare. With the anticipated growth in cancer cases as wor
19、ld populations age, the discovery of more effective cancer management tools has become critical. It is becoming too expensive to continue prescribing drugs that are largely ineffective. From a commercial standpoint, tests for cancer management will remain a high priority for the next 25 years. Immun
20、oassays and histological analysis of biopsied tissue are the mainstay of in vitro cancer diagnostics. The maturation and standardization of molecular Four: Market Analysis 38 Four: Market Analysis 38 tests with next generation technologies will enhance the diagnostic and prognostic abilities of canc
21、er diagnostics. As researchers continue to unravel the complexities of cancer processes, it has become increasingly apparent that future diagnostics will go beyond correlating a single protein or gene to the disease, and instead tests will look at characteristic gene and protein patterns or signatur
22、es to diagnose and predict disease progression. Cancer is a highly complex disease and no single test or test segment is specific enough to provide a highly accurate assessment of a patients disease status. Physicians therefore rely on a panel of tests that includes genetic markers, cell protein mar
23、kers, and biochemical indicators of tissue impairment. Cancer diagnosis and monitoring is too complex and involves too many different biological processes for physicians to rely on a single technology or set of testing techniques. Future diagnostic strategies remain similar to that used today - a mi
24、x of immunoassays, chemistries, histological tissue analysis, and in vivo imaging. Oncolgists rely on a combination of many technologies FISH, IHC, molecular, multitests, sequencing, and circulating tumor cells. As more is discovered about the complexity of cancer, new panels of genomic tests enable
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