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Described are platforms, systems, media, and methods for providing a biologic information visual synthesis application, the biologic information including one or more of: genome data, microbiome data, and metabolome data.


NEW YORK, May 11, 2017 /PRNewswire/ -- This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments. The report is supported by over 360 tables & figures over 397 pages. The personalized medicine (global & USA) market is presented as follows: Read the full report: http://www.reportlinker.com/p03118741/Personalized-Medicine-Targeted-Therapeutics-and-Companion-Diagnostic-Market-to-Strategic-Analysis-of-Industry-Trends-Technologies-Participants-and-Environment.html • By Company (e.g., Qiagen, AFFYMETRIX, ATOSSA GENETICS, NODALITY, deCode /Amgen, CELERA, MYRIAD) • By Segment (Targeted therapeutics, Companion Diagnostics, Liquid Biopsies) • By Sub-market (Companion diagnostic, targeted cancer therapeutic, medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy) • By Therapy (Cancer, Cardiovascular, Infectious Disease) Key Opinion Leaders that contributed to interview questions within the report include: • Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group • Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James's Hospital and Trinity College Dublin, Ireland • Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Department of Veterans Affairs, Washington DC • Elaine Kenny, PhD, Founder, Elda Biotech, Dublin 2, Ireland • Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine • Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine • David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine • Deborah Phippard, PhD, Vice President, Research, Precision for Medicine • Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine A wealth of financial data & business strategy information is provided including: • Company financials, sales & revenue figures • Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies • Business Model Strategies for Providers. Provider Systems and Academic Medical Centres • Business Model Strategies for Payers & Governments • Private and Public Funding and Personalized Medicine Reimbursement • Revisions to Current Payment Systems and intellectual property • How to Gain Market Penetration in the EU • Cost-effectiveness and Business Value of Personalized Medicine • Therapeutics and Companion Diagnostics (e.g., BRAC Analysis, Oncotype Dx , KRAS Mutations) • Comprehensive account of company product portfolios & kits SWOT, Economic & Regulatory Environment specifics include: • Key strengths, weaknesses and threats influencing leading player position within the market • Technologies driving the market (e.g., New-Generation Sequencing Technologies, Ultra-High Throughput Sequencing) • Top fastest growing market segments and emerging opportunities • Top pharmaceutical companies within the IPM by market share and revenue • Comprehensive product portfolios, R&D activity and pipeline therapeutics • M&A activity and future strategies of top personalized medicine pharmacos • Personalized Medicine Regulation (USA, UK, Germany, France, Spain, Italy) • CE-marked Personalized Medicine/Diagnostic Tests • FDA Advances in Personalized Medicine Regulation This report highlights a number of significant pharmacos and gives details of their operations, products, financials and business strategy. • 23andMe • Abbott Laboratories • Abbott Molecular Inc. • Admera Health (GENEWIZ) • Affymetrix • Agendia • Alere • Amgen • Astex Pharmaceuticals • AstraZeneca • Atossa Genetics • Becton Dickenson • bioMerieux • BristolMyersSquibb • Cancer Genetics • Celera (Quest Diagnostics) • Celldex Therapeutics • Claritas Genomics • CuraGen • Danaher (Leica Biosystems) • deCode Genetics (Amgen) • Foundation Medicine • EDP Biotech • Eli Lilly • ELDA BioTech • Eisai • Genelex • GlaxoSmithKline • Human Longevity Inc (Cypher Genomics) • HalioDx • Ikonisys • Illumina • InterGenetics • Johnson & Johnson • LabCorp • Life Technologies • Merck • MDxHealth • MolecularMD Corporation • Monogram Biosciences • Myriad • Nodality • Novartis MDx • Orion Genomics • Oxford BioTherapeutics • NanoString Technologies • Pfizer • Qiagen • Roche Molecular Diagnostics • Sanofi • SensiGen • Siemens Healthcare Diagnostics • Takeda • Thermo Fisher Scientific • Transgenomic • Ventana (Roche) • Vermillion (Ciphergen) • Vertex Pharmaceuticals What you will gain: • An in-depth understanding of the global personalized medicine market and it's environment • Current market facts, figures and product lines of key players in the industry • Emerging trends in key markets such as the US, UK, Germany and France • Knowledge of how the personalized medicine market will integrate into the global healthcare market • Technical insights into new generation sequencing technologies and ultra-high throughput sequencing • Updates on bioinformatics, high throughput systems, genetic analysis kits, companion diagnostics and future technologies • FDA approved pharmacogenetic tests and recognized biomarkers • Information on key government and regulatory policies • Strategies on how to adapt and restructure current business models to this industry This report tackles key concerns to the personalized medicine market such as: • Lack of regulatory policy and legislation in the US and Europe • Reimbursement schemes and payers concerns • Transition of investigational diagnostic assays and therapeutics to clinical practice • Direct to consumer (DTC) test kits and implications for the public Who should read this report? • Pharmaceutical, biotechnology and diagnostic companies (CEOs, VPs, Business Development, C-Suite)with an interest in personalized medicine • Industry professionals and business strategists will discover key information to propel their policies • Investors will gain inside information to dominant players in the industry and future forecasts • Scientists will get a business perspective and industry insight into how scientific breakthroughs influence the market environment This report will tell you if the companies mentioned are: • Strong, competitive players • Pooling their resources for specific growth and therapeutic areas • Investing strategically in R&D • Have a history of strategic M&A activity This detailed report is supported with 360 figures and tables over 397 pages and profiles the main pharmacos in personalized medicine. Benefits of Investing in our Cutting-Edge Reports: - Clients receive complementary content* with mid-level and enterprise wide licences - Post-sale complementary consultation with senior expert analyst is included - Use of tables and figures in your own reports and presentations is permitted - Each report provides straight-talking strategic analysis & sector intelligence - All reports are updated each quarter to give you the most up-to-date information Executive Summary Kelly Scientific forecasts that the companion diagnostic and targeted therapeutic submarkets of the personalized medicine industry were worth $113 billion in 2016, and will hit over $162 billion by 2021 with a CAGR of 8.74%. The total personalised therapeutic market, for all indications, will be worth $x billion by 2021, with a CAGR of x%. Currently it is estimated that the companion diagnostic segment is worth $x billion globally, mainly coming from oncology, cardiovascular and infectious disease (HIV/HCV) tests. This is set to rise vertically over the next five years and by 2021 will be worth over $x billion, with a CAGR of x%. This study details a comprehensive financial and strategic review of key players in the personalized medicine industry. Significant drivers and restraints of this market are revealed and market opportunities and challenges are identified. Disruptive technologies that are propelling the personalized medicine and companion diagnostic market are scrutinized. It examines the current genetic diagnostic tests and companion diagnostic assays that are in use by the medical and pharmaceutical industry today. Current developments in personalized medicine and the pharmacogenomics revolution are discussed. The emerging trends that appear in key markets such as the US, UK, Germany and France are elucidated and analysed. This study reveals market figures of the overall personalized medicine market and also sub-market figures with respect to companion diagnostics, targeted cancer therapeutics, medical technologies, pharmacogenomics, consumer genomics, molecular diagnostics and liquid biopsies. Specific indication markets are also included such as cancer, cardiovascular and infectious disease. The report provides value and growth of the global personal therapeutics market from 2017-2021. Also historic figures back to 2014 are given to illustrate growth. As the personal targeted therapeutics market is part of the overall personalized medicine market, the companion diagnostics market is also included in the report The report goes into detail regarding different indications, mainly oncology drugs as these hold most market share, and also cardiovascular and infectious disease markets. It contains specific data for both the targeted therapeutic and companion diagnostic sections of the personalized medicine market. These sections are then further divided into indications – Oncology, Cardiovascular and Infectious Disease The report also analyses the market with regards to major players such as GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche. To give an comprehensive view of how the PM market relates to associated markets, a number of these are analysed and forecast to 2021 (medical technology, pharmacogenomics, consumer genomics, molecular diagnostics, liquid biopsy). For example, data from the targeted therapeutics section includes the following specifics: • Targeted Therapeutic Sales Revenue, All Indications (by Company, GSK, Amgen, Sanofi, Novartis, Janssen, BMS, Pfizer, AstraZeneca, Roche). • Global Targeted Therapeutic Market, All Indications, Forecast 2014-2021 • Global Oncology Targeted Therapeutics Forecast 2014-2021 • HER-2 Positive Breast Cancer Targeted Therapeutic Market Forecast 2014-2021 • Oncology Targeted Therapeutic Market Forecast By Drug 2014-2021 (Herceptin Erbitux Gilotrif Gleevec Mekinist Tafinlar Zelboraf Tarceva Xalkori Zelboraf Kadcyla Perjeta Adcetris Xeloda Afinitor, Faslodex Iressa, Revlimid Avastin Alimta) • Branded Oncology Therapeutics Market Share 2014-2021 (Herceptin Erbitux Gleevec Tarceva Kadcyla Perjeta Xeloda Afinitor Revlimid Avastin Alimta) • Top Pharma Companies Revenue from Targeted Therapeutics in Oncology (Roche, Novartis, Janssen, BMS, AstraZeneca, Sanofi, GSK, Pfizer, Amgen, Eli Lilly) • Branded Cardiovascular Targeted Therapeutic Total Market 2014-2021 • Branded Cardiovascular Targeted Therapeutics Market Forecast by Drug 2014-2021 (Metoprolol, Bidil, Plavix, Carvedilol) • Infectious Disease Targeted Therapeutics Market to 2014 - 2021 • Branded Infectious Disease Targeted Therapeutics Market by Drug 2014-2021 (Incivek, Pegasys, Selzentry, Ziagen, Sovaldi, Harvoni) Similarly, data for the companion diagnostic section is given. Personalized Medicine Targeted Therapeutics – Oncology In order to get an in depth understanding of the oncology therapeutics section within the personalized medicine market it is important to initially review the global oncology therapeutics market. Oncology continues to be an area of high unmet need and product revenue potential. Oncology is the largest global therapeutic area, with global sales of $x billion in 2016; that is anticipated to reach $x billion by 2021. Increasing cancer prevalence globally is a major driver of the market, and this is further underlined by more sensitive diagnostics and screening methods. The predicted revenue growth in the oncology space is reinforced by increasing cancer prevalence, as well as advances in diagnosis methods and screening programs. The current trend is that patients are advancing to 2nd, 3rd and 4th line therapy regimes, and so this progression further expands the market. A significant driver of revenue growth is the cost of oncology therapeutics and biologics. For example, Yervoy (BMS) annual costs are $x for four doses. Another example is Dendreon's Provenge which has an annual cost of $x for three doses. This significant increase in the price of oncology therapeutics has expanded the market, even though price reductions have been fought for by payers. Targeted Cancer Therapeutics Targeted cancer therapeutic sales have significantly risen in the recent past with a x% increase from 2013 to 2014 alone. The global oncology market is currently booming and one of the main reasons for this increase is the dramatic rise in the number of prescribed targeted therapies. The market is also growing in size as the cost of targeted therapeutics is high. This is due to longer treatment times, increased investment and development costs. Targeted therapeutics also are, by definition, designed to treat smaller cohorts of patients, albeit more effectively. Therefore, pharmaco's need to recoup costs via pricing. Two major targeted therapeutics on the market are Roche's melanoma agent Zelboraf and Pfizer's lung cancer agent Xalkori. Zelboraf (vemurafenib) is a MEK inhibitor indicated for skin cancer and in FY2013 reached $x million. Xalkori (crizotinib) is indicated in patients positive for an ALK mutation and has an annual sale figure of €x million. Top Ten Companies in Oncology Drug Sales Roche Holdings continues to occupy its first position in oncology market. The company's sales performance was driven by HER 2-positive breast cancer therapies. Globally, it is the largest maker of cancer treatments and mainly focuses on biologic drugs. Most of its cancer drugs are developed by California-based Genentech, a pioneer in biologic therapies that Roche acquired in 2009. Worldwide sales of Herceptin, that is about to lose patent protection year, rose 9%. But sales of Perjeta and Kadcyla, two follow-on therapies, increased by triple-digit percentages, drawing attention to the company's success in developing successor products. Roche is pinning its hopes on follow-on products to preserve its place in the market once generic competition, known as biosimilars, begin to appear. These biologic therapies usually have higher margins than conventional drugs and are more difficult to copy. Bristol-Myers Squibb's overall sales rose by about x% only, but its cancer immunotherapy drugs witnessed huge sales gains. Its Yervoy, a skin-cancer immunotherapy, leaped x% to $x million in the fourth quarter, while Opdivo, another skin-cancer drug approved in late December 2014, contributed sales of $x million. The company's sales of leukemia drug Sprycel rose x% to $x million in 2016. Celgene Corporation has reported that its revenue rose in the most recent period, driven by sales growth of its key cancer treatment, particularly in the U.S. The company expects 2015 to be an important year for Revlimid, a blockbuster blood-cancer drug, which will be tested in trials for treatment of a kind of lymphoma. The FDA is expected to decide whether the drug can be used to treat newly diagnosed multiple myeloma. Regulatory bodies in the U.S. and the E.U. are making key decisions on the drug. Revlimid sales increased x% to $x billion in the most recent quarter, as market share expanded along with the duration of therapy. U.S. sales of the drug grew by x% while international sales increased x%. The personalized medicine, targeted therapeutic and associated companion diagnostic market have huge opportunities for growth. This industry will revolutionize the healthcare system and will improve therapeutic effectiveness and reduce the severity of adverse effects. It has enormous potential for investment and the emergence of genetic-based in vitro diagnostics. Companies Mentioned • 23andMe • Abbott Laboratories • Abbott Molecular Inc. • Admera Health (GENEWIZ) • Affymetrix • Agendia • Alere • Amgen • Astex Pharmaceuticals • AstraZeneca • Atossa Genetics • Becton Dickenson • bioMerieux • BristolMyersSquibb • Cancer Genetics • Celera (Quest Diagnostics) • Celldex Therapeutics • Claritas Genomics • CuraGen • Danaher (Leica Biosystems) • deCode Genetics (Amgen) • Foundation Medicine • EDP Biotech • Eli Lilly • ELDA BioTech • Eisai • Genelex • GlaxoSmithKline • Human Longevity Inc (Cypher Genomics) • HalioDx • Ikonisys • Illumina • InterGenetics • Johnson & Johnson • LabCorp • Life Technologies • Merck • MDxHealth • MolecularMD Corporation • Monogram Biosciences • Myriad • Nodality • Novartis MDx • Orion Genomics • Oxford BioTherapeutics • NanoString Technologies • Pfizer • Qiagen • Roche Molecular Diagnostics • Sanofi • SensiGen • Siemens Healthcare Diagnostics • Takeda • Thermo Fisher Scientific • Transgenomic • Ventana (Roche) • Vermillion (Ciphergen) • Vertex Pharmaceuticals Read the full report: http://www.reportlinker.com/p03118741/Personalized-Medicine-Targeted-Therapeutics-and-Companion-Diagnostic-Market-to-Strategic-Analysis-of-Industry-Trends-Technologies-Participants-and-Environment.html About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place. http://www.reportlinker.com __________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/personalized-medicine-targeted-therapeutics-and-companion-diagnostic-market-to-2021--strategic-analysis-of-industry-trends-technologies-participants-and-environment-300456319.html


Personal DNA sequencing once promised to up the ante for individualized medicine. Perhaps no one believed that more than human genomics pioneer J. Craig Venter, who in 2014 co-founded a company called Human Longevity to predict and prevent disease by sequencing a million human genomes. But Venter is no longer content with your DNA. His latest venture—a subsidiary called Health Nucleus based in San Diego, California—says it can detect undiagnosed health problems by combining DNA analyses with a $25,000 workup including a whole-body MRI scan, metabolomics screening, 2 weeks of constant heart monitoring, pedigree analysis, microbiome sequencing, and a glut of standard laboratory tests. Enthusiasts of “precision medicine” say this kind of screening—similar to the U.S. National Institutes of Health’s (NIH’s) Precision Medicine Initiative—is the way of the future. But many other clinicians and researchers are leery or even downright outraged by the program’s potential for over diagnosis and what they see as lack of evidence for its benefits. Late last week, Venter and co-workers quietly published a paper on the preprint server bioRxiv—which does not use peer review—that appears to present data from the new project. According to the study, screening detected “age-related chronic diseases requiring prompt (<30 days) medical attention” in 8 % of the 209 participants, and MRIs found early-stage cancer in 2%. However, Health Nucleus did not confirm that the data were from its $25,000 medical exam, although descriptions of the diagnostics were nearly identical. “It’s a classic Craig Venter study that pushes the envelope of what is considered reasonable,” says Olivier Elemento, associate director at the Institute for Computational Biomedicine at Weill Cornell Medicine in Ithaca, New York. Meanwhile, Venter has been making the media rounds to promote the screening. On Fox Business, he said the exam finds “something seriously wrong” in 40% of participants (though that claim is left unexplained). CBS News reports that Venter’s group can predict Alzheimer’s disease 20 years in advance by scanning the 20 regions of the brain. And STAT news reports that the exams detect tumors early enough that every participant with cancer so far has been able to treat it, even the notoriously unforgiving pancreatic cancer. A spokesperson for Human Longevity said they would not comment on the contents of the paper until it is published in a peer-reviewed journal. Critics aren’t buying it. “If I wanted to write a Swiftian parody illustrating the insanity of this extreme version of [precision medicine], I could not have written a better paper,” says Nigel Paneth, a pediatrician and epidemiologist from Michigan State University in East Lansing, who cites a litany of problems that could result from the study including psychological damage, high medical costs, unnecessary tests, and “the absence of the slightest shred of evidence that any benefit will accrue to anyone.” Eric Topol, director of Scripps Translational Science Institute in San Diego says this is “kind of the most extensive diagnostic evaluation of people that has ever been done,” but he takes issue with billing the study as a precision medicine screening. “Is this precise or is this promiscuous?” he asks. “That term ‘precision medicine screening’ is very difficult to accept unless you prove that you are actually helping people. That hypothesis is still unproven after this paper was published,” Topol says. “What if it helps one and harms 10?” He’s particularly concerned  about running tests on people without a sound rationale. “Don’t do a bunch of tests unless there is a good reason; otherwise you get a bunch of false positives.” The study included twice as many men as women, and participants ranged in age from 20 to 98, with an average age of 55. A whopping 78% had “evidence of age-related chronic disease or risk factors,” which for the majority translated to diabetes or risk of atherosclerotic disease. Michael Joyner, a medical doctor and integrative physiology researcher at the Mayo Clinic in Rochester, Minnesota, also notes that over 70% of the participants are currently taking prescribed medication for high LDL cholesterol and hypertension. “To tell me that a bunch of 60-year-old men with prolonged EKG monitoring had some funny heartbeats … is news, give me a break,” he says. “The whole thing is an example of technology run amok from a belief that if you can measure it, it must be meaningful.” But the amped up testing has its proponents. “The over-diagnosis concern is completely over-exaggerated,” says Michael Snyder, the director of the Stanford Center for Genomics and Personalized Medicine in Palo Alto, California, who made news 5 years ago when he detected his own diabetes by intensively studying his body. “Some of the stuff they found seems pretty serious, so I think it is a good thing to catch that early,” he says, predicting that in the future, “we will be measuring thousands of things much more routinely.” Despite Venter’s personalized genomics evangelism, the study’s results pointedly indicate that “the genome alone doesn’t tell you the whole story,” says Elemento of Cornell. Only 25% of patients had probable links between gene variants and disease phenotypes. “But when you can combine genes with an additional readout that tells you the gene is doing something, your ability to predict disease increases dramatically.” Some see the early data from Health Nucleus as the potential start of another Venter-versus-the government scenario. “What Venter has done here is pretty much the goal of NIH’s Precision Medicine Initiative, and I imagine Craig envisions immediate scale-up to compete with that particular government project,” says Robert W. West Jr., who previously taught a course on precision medicine at SUNY Upstate Medical University. “If this is really Craig’s goal, then he would likely beat NIH to the punch again.” Health Nucleus says 570 people have participated in the full $25,000 panoramic medical workups thus far, but this week they launched a $7500 pared-down version that focuses on the full genome sequencing and full-body scan. “This is a study that is going to remain controversial,” Topol says. “And maybe it is futuristic, but I think most people in medicine who understand the history of this will know that this is potentially engendering trouble and doing all sorts of tests that don’t have any basis.”


News Article | May 3, 2017
Site: www.medicalnewstoday.com

The study - by researchers from the University of California-San Diego (UCSD) and colleagues from Human Longevity, Inc. in San Diego and the J. Craig Venter Institute in La Jolla, both in California - is published in the journal Cell Metabolism. Nonalcoholic fatty liver disease (NAFLD) is a condition characterized by a buildup of fat in the liver. According to the National Institute of Diabetes and Digestive and Kidney Diseases, it is "one of the most common causes of liver disease in the U.S." NAFLD is a different condition to alcoholic liver disease, in which the fat buildup is due to heavy alcohol use. In the new study - which involved 135 participants and establishes "proof of concept" - the researchers found that the stool-based test was able to predict advanced NAFLD with an accuracy of between 88 and 94 percent. First author Rohit Loomba, a professor of medicine and director of the NAFLD Research Center at UCSD, says that determining who has or is at risk for NAFLD is a "critical unmet medical need." Although there are dozens of new drugs in the pipeline, if it were possible to better diagnose the disease, then patients could be better selected for trials and "ultimately [we] will be better equipped to prevent and treat it," Prof. Loomba adds. There are two forms of NAFLD: simple fatty liver and nonalcoholic steatohepatitis (NASH). Simple fatty liver is a form of NAFLD in which there is fat in the liver but without inflammation or cell damage. This form does not usually lead to liver damage or complications. NASH is type of NAFLD where, in addition to fat buildup, the liver also shows signs of inflammation and liver cell damage. The inflammation can lead to scarring or fibrosis, and then to more severe cirrhosis, which alters the liver's fundamental biology. NASH can also progress to liver cancer. Nobody knows exactly what causes NAFLD, or why some of the people affected have simple fatty liver while others have NASH. Estimates suggest that around 20 percent of people with NAFLD have NASH. In the U.S., between 30 and 40 percent of adults are thought to have NAFLD, and approximately 3 to 12 percent have NASH. Being obese - and having conditions related to obesity, such as type 2 diabetes - raises the risk of developing NAFLD. Prof. Loomba and colleagues note that NAFLD is thought to affect up to 50 percent of obese people. In their study report, the researchers note how studies have shown that the makeup of a person's gut microbiome - the trillions of microbes that live in the gut together with their genetic material - may affect their risk for obesity. This set them wondering if there might also be a link between obesity-related liver disease and the gut microbiome. If this is true, then it may be possible to analyze the makeup of the gut microbiome from a person's stool sample and link that to their NAFLD status. To test this theory, the team first examined 86 patients with NAFLD diagnosed by biopsy - including 72 with mild or moderate disease and 14 with advanced disease. They sequenced the genes from the participants' stool samples - analyzing the presence, location, and relative abundance of various microbe species. This process identified 37 species of bacteria that differentiated advanced NAFLD from the mild or moderate stage with 93.6 percent accuracy. The researchers then validated the finding in a second group of 16 patients with advanced NAFLD and 33 healthy volunteers who acted as controls. This time, they found that by testing the relative abundance of nine species of bacteria - seven of which were in the 37 identified previously - they could differentiate the NAFLD patients from the controls with 88 percent accuracy. The researchers are keen to point out that so far, the test has only been trialed on a small number of patients in a highly specialized setting. Even if further studies validate it, a stool sample test for NAFLD is unlikely to be available for clinical use for at least 5 years. Learn how a protein discovery may offer a new treatment target for NAFLD.


News Article | May 2, 2017
Site: www.eurekalert.org

Nonalcoholic fatty liver disease (NAFLD) -- a condition that can lead to liver cirrhosis and cancer -- isn't typically detected until it's well advanced. Even then, diagnosis requires an invasive liver biopsy. To detect NAFLD earlier and more easily, researchers in the NAFLD Research Center at University of California San Diego School of Medicine, Human Longevity, Inc. and the J. Craig Venter Institute report that the unique microbial makeup of a patient's stool sample -- or gut microbiome -- can be used to predict advanced NAFLD with 88 to 94 percent accuracy. The proof-of-concept study, which involved 135 participants, is published May 2 in Cell Metabolism. "We estimate that as many as 100 million adults and children in the U.S. may have NAFLD. Determining exactly who has or is at risk for the disease is a critical unmet medical need," said first author Rohit Loomba, MD, professor of medicine in the Division of Gastroenterology, director of the NAFLD Research Center and a faculty member in the Center for Microbiome Innovation at UC San Diego. "There are about 50 new NAFLD drugs in the pipeline, including about five that will likely be approved for use in the next two years. If we are better able to diagnose this condition, we will be better at enrolling the right types of patients in these trials, and ultimately will be better equipped to prevent and treat it." The precise cause of NAFLD is unknown, but diet and genetics play substantial roles. Up to 50 percent of obese people are believed to have NAFLD. As mounting evidence continues to suggest that the makeup of a person's gut microbiome may influence his or her risk for obesity, Loomba and team began to wonder if the gut microbiome might also be linked to obesity-associated liver disease. If so, they hypothesized that a stool-based "read-out" of what's living in a person's gut might provide insight into his or her NAFLD status. To answer these questions, Loomba and team examined two different patient groups. The first group included 86 patients with NAFLD, as diagnosed by biopsy. Of these, 72 had mild/moderate NAFLD and 14 had advanced disease. Collaborators at Human Longevity, Inc. sequenced the microbial genes extracted from each participant's stool sample and used that information to determine which species were living where, and the relative abundance of each. The researchers found 37 bacterial species that distinguished mild/moderate NAFLD from advanced disease, allowing them to predict which patients had advanced disease with 93.6 percent accuracy. The team validated this finding with a second study group that included 16 patients with advanced NAFLD and 33 healthy people as controls. In this case, they found nine bacterial species whose relative numbers allowed them to distinguish NAFLD patients from the healthy volunteers, with 88 percent accuracy. Seven of these bacterial species overlapped with the signature 37 used in the previous group. There are four main types of bacteria found in the human gut: Firmicutes, Proteobacteria, Bacteroidetes and Actinobacteria. Loomba and team found that patients with advanced NAFLD tend to have more Proteobacteria and fewer Firmicutes in their stool than those with early stage NAFLD. At the species level, one major difference the researchers found was in the abundance of E. coli -- these bacteria were three-fold more common in advanced NAFLD patients than early stage patients. "We believe our study sets the stage for a potential stool-based test to detect advanced liver fibrosis based simply on microbial patterns," said senior author Karen E. Nelson, PhD, president of the J. Craig Venter Institute, "or at least help us minimize the number of patients who have to undergo liver biopsies." While Loomba estimates that a stool-based microbiome diagnostic might cost $1,500 if it were on the market today, he predicts that cost will lower to less than $400 in the next five years due to advances in genomic sequencing and analysis technologies. While excited, the researchers caution that so far this new diagnostic approach has only been tested in a relatively small patient group at a single, highly specialized medical center. The team is now applying for grant funding to expand their study in a larger cohort across multiple sites. Even if successful, a stool-based test for NAFLD wouldn't be available to patients for at least five years, they said. Loomba also points out that while a distinct set of microbial species may be associated with advanced NAFLD, this study does not suggest that the presence or absence of these microbes causes NAFLD or vice versa. "We are looking forward to further studies to assess the role, if any, these microbial species play in gut permeability, liver inflammation and cross-talk with other factors to induce liver injury, and ultimately influence disease progression in NAFLD," said study co-author David A. Brenner, MD, vice chancellor of UC San Diego Health Sciences and dean of UC San Diego School of Medicine. "Understanding the microbiome, just as sequencing the human genome, is one part of the puzzle on human health and disease," said study co-author J. Craig Venter, PhD, co-founder and executive chairman of Human Longevity, Inc. "New technologies, such as machine learning, are allowing for tremendous advances to interpret these data." Co-authors of this study include: Victor Seguritan, Tao Long, Niels Klitgord, Marcus B. Jones, William Biggs, Human Longevity, Inc.; Weizhong Li, Shibu Yooseph, Human Longevity, Inc. and J. Craig Venter Institute; Archana Bhatt, Parambir Singh Dulai, Richele Bettencourt, Cyrielle Caussy, Claude B. Sirlin, Bernd Schnabl, Chi-Hua Chen, UC San Diego; Sarah K. Highlander, Lauren Brinkac, and Nicholas Schork, J. Craig Venter Institute.


The global predictive genetic testing & consumer/wellness genomics market is anticipated to reach USD 4.6 billion by 2025 Key drivers attributing to the market expansion include rising awareness pertaining to the use of genomic tests for the prediction of gene susceptibility for probability of disease development. Genetic data in the ecosystem increases when consumers buy direct-to-consumer genomics products or participate in clinical research trials. Rising encouragement for the use of these products is anticipated to propel industrial growth. Expansion in the range of consumer genetic tests by market entities is anticipated to fuel progress in the market in the coming years. Introduction of novel platforms anticipates the DNA-powered applications thus rising market penetration. Moreover, the pharmaceutical companies are also engaged in partnerships with genomics companies in order to develop novel therapeutics on the basis of genotypic and phenotypic correlations. For instance, in April 2016 a ten-year deal was signed between Human Longevity Inc. (HLI) and AstraZeneca, in which HLI is supposed to sequence 500,000 genomes of the clinical trial population of AstraZeneca. This data is to be used for the identification of novel drug targets. The deal also provides AstraZeneca with access to the proprietary knowledgebase in order augment biomarker discovery, and facilitate drug development. Further Key Findings from the Study Suggest: 1 Research Methodology 2 Executive Summary 3 Predictive Genetic Testing & Consumer/Wellness Genomics Market Variables, Trends & Scope 3.1 Market Segmentation & Scope 3.1.1 Market Driver Analysis 3.1.1.1 Rise in number of novel partnership models 3.1.1.2 Introduction of fragmented point-solutions across the genomics value chain 3.1.1.3 Exponentially decreasing costs for genetic sequencing 3.1.1.4 Introduction of technological advancements in cloud computing and data integration 3.1.2 Market Restraint Analysis 3.1.2.1 Absence of well-defined regulatory framework and low adoption rate 3.1.2.2 Ethical concerns pertaining to implementation 3.2 Penetration & Growth Prospect Mapping for Applications, 2015 3.3 Predictive genetic testing & consumer/wellness genomics-Swot Analysis, By Factor (Political & Legal, Economic And Technological) 3.4 Industry Analysis - Porter's 4 Predictive Genetic Testing & Consumer/Wellness Genomics Market: Test Type Estimates & Trend Analysis 4.1 Predictive Genetic Testing & Consumer/Wellness Genomics Market: Test Types Movement Analysis 4.2 Predictive Testing 4.2.2 Genetic susceptibility test 4.2.3 Predictive diagnostics 4.2.4 Population screening programs 4.3 Consumer Genomics  4.4 Wellness Genetics 4.4.2 Nutria Genetics 4.4.3 Skin & Metabolism Genetics 4.4.4 Others 5 Predictive Genetic Testing & Consumer/Wellness Genomics Market: Application Estimates & Trend Analysis 5.1 Predictive Genetic Testing & Consumer/Wellness Genomics Market: Application Movement Analysis 5.2 Breast & Ovarian Cancer Screening 5.3 Cardiovascular Screening 5.4 Diabetic Screening & Monitoring 5.5 Colon Cancer Screening 5.6 Parkinsonism / Alzheimer's disease 5.7 Urologic Screening/ Prostate Cancer Screening 5.8 Orthopedic & Musculoskeletal Screening 5.9 Other Cancer Screening 5.10 Other Diseases Screening 6 Predictive Genetic Testing & Consumer/Wellness Genomics Market: Regional Estimates & Trend Analysis, by Test Type & Application 7 Competitive Landscape For more information about this report visit http://www.researchandmarkets.com/research/hdjzfv/predictive To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/research-and-markets---global-predictive-genetic-testing-and-consumerwellness-genomics-market-2013-2017--2025-key-players-are-bgi-illumina-pathway-genomics-genesis-23andme-arup-color-genomics--myriad-300447969.html

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