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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


In addition to national recognition for her contributions to quality programs in the clinical lab and beyond, Cardinal Health will provide a $25,000 educational grant to the institution of higher learning of Dawson's choice. Dawson's grant will go to Texas State University to support students pursuing careers in clinical laboratory science. "As a passionate advocate of the laboratory and its role in providing quality care and the highest level of patient safety, I'm humbled and honored to be recognized with this prestigious laboratory award," said Dawson. "I hope this spreads awareness of the impactful work being done by medical laboratory professionals and inspires others to pursue a career in this rewarding field." Dawson is currently the senior director of Quality for Human Longevity, Inc. in San Diego and affiliate faculty at Regis University in Denver. Over the course of her career, she has developed or revamped quality programs for many laboratories, including building multiple labs and lab quality programs and providing consulting services. She previously served as vice president of Quality and Regulatory Affairs for Sonic Healthcare USA (SHUSA), one of the largest lab networks in the U.S. During her tenure, she was one of four executives to build SHUSA's national esoteric reference lab from the ground up. The non-conforming event management programs Dawson has developed and implemented allow laboratories to identify non-conforming events, eliminate root causes, and proactively correct issues before patients are affected. In addition, Dawson is heavily involved in calculating the Cost of Poor Quality, which allows laboratories to demonstrate the financial benefits of quality programs. She frequently publishes articles, presents posters and aims to spread awareness and further knowledge about lab quality. Showcasing the impact Dawson has already had on the laboratory industry, she's been recognized with several accolades, including: This marks the fourth year for the Cardinal Health™ urEssential Award program. Individuals working in the clinical laboratory profession may be nominated by their managers, colleagues, peers and students, or they may self-nominate. The award seeks to recognize clinical laboratory professionals who have improved their current (or former) laboratory, enhanced patient care through their work, and increased the awareness of the importance of the profession. For more information on the Cardinal Health™ urEssential Award program, and to learn more about Dawson and the five distinguished professionals selected as 2017 finalists, visit www.cardinalhealth.com/urEssential. About Cardinal Health Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. The company provides clinically proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. As a distributor, Cardinal Health helps ensure pharmacists, and the consumers they serve, have access to medications they need while working to help prevent prescription drug diversion; therefore, along with its education partners, Cardinal Health created Generation Rx, a national program to help prevent the misuse of prescription medications. Backed by nearly 100 years of experience, with more than 40,000 employees in nearly 60 countries, Cardinal Health ranks among the top 25 on the Fortune 500. For more information, visit cardinalhealth.com, follow @CardinalHealth on Twitter and connect on LinkedIn at linkedin.com/ company/cardinal-health. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/patient-safety-advocate-earned-cardinal-health-uressential-laboratory-professional-of-the-year-award-300455532.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.

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