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Nonalcoholic Liver Disease and Genetics: Is There a Link?
What exactly is the relationship between genetics and disease? Powered by Renown Health, the Healthy Nevada Project is one of the most visible genomic studies in the United States. They are recruiting participants here in northern Nevada to understand the relationship between genetics and nonalcoholic liver disease. Joseph Grzymski, Principal Investigator at the Healthy Nevada Project and Chief Scientific Officer at Renown Health, shares why this study is so important and who should take part. Many people are aware that heavy drinking can lead to liver disease. Yet they are unaware that other types of liver disease are not caused by alcohol consumption. These types of liver disease are more difficult to diagnose but are equally dangerous. What is NASH? A build-up of fat causes nonalcoholic Fatty Liver Disease (NAFLD) in the liver. The most dangerous form is called Nonalcoholic Steatohepatitis (NASH). It causes inflammation and damages liver cells, leading to fibrosis, scarring of the liver, and decreased liver function. If NASH goes untreated, irreversible liver damage can occur, leading to cirrhosis, cancer, or liver failure. These conditions can be fatal. What’s most concerning about NASH is that the symptoms don’t typically cause pain and aren’t noticeable. The good news is that a new local study is raising awareness about this disease by recruiting at-risk people for NASH. Am I at risk for developing NASH? The following factors put you at risk: Obesity Type 2 diabetes Metabolic syndrome High blood lipids, such as cholesterol and triglycerides Does having a family member with nonalcoholic liver disease increase my risk? We do not know a lot about inheriting NASH, although a lot risk factors run in families. One goal of this study is to better understand the genetic component of NASH. There are certainly other risks too, such as environmental and behavioral risk factors. However, we don’t yet have a good grasp on how these impact NASH risk. How is NASH diagnosed? Diagnosis is traditionally done with either a liver ultrasound or biopsy. However, both procedures are expensive and the invasive biopsy has risks. Therefore doctors often use risk factors or less invasive blood tests for diagnosis. This NASH study will include a new blood test called the enhanced liver function (ELF) test. Doctors and researchers have data suggesting that the ELF test is a better diagnostic test for NASH risk. Conducting this cutting-edge test with study participants allows them to share results with their doctors to ensure the best care. What can I do to reduce my NASH risk? Limiting exposure to the risk factors of NASH often lowers risk. Eating a healthy diet, maintaining a recommended weight and exercising regularly can proactively lower your risk.
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Taking Control of Her High Cholesterol and Health
In 2018, Jordan Stiteler became a Healthy Nevada Project advocate. Her DNA results revealed that she had Familial Hypercholesterolemia (FH). FH is a genetic condition that can cause high cholesterol. Since then, Jordan’s taken action to lower her cholesterol and make her family aware of this potentially dangerous condition. Read Part I of Jordan’s story Taking Control of High Cholesterol Looking at Jordan, an active young mother, you would never suspect she has high cholesterol. However, because of FH, Jordan’s cholesterol levels are unusually high. She chose to take action when learning of her FH gene, in order to maintain her long-term health. Jordan started by exercising more and eating healthier. “I’ve definitely been checking all the labels to see if the food has a lot of cholesterol, trans fats, or saturated fats,” she explains. She now eats a 100% plant-based diet which helps to lower her cholesterol naturally. Additionally, Jordan partnered with Dr. Michael Bloch, a lipid specialist, to monitor and manage her cholesterol. She told Dr. Bloch that she and her husband were planning on having a second baby. With this in mind, he helped Jordan create a plan to accommodate her pregnancy. Several months after giving birth to her beautiful daughter Logan, it was time to revisit her cholesterol treatment plan. Dr. Bloch prescribed Jordan a statin called Lipitor. It successfully cut her total cholesterol by half in just three months. “I had blood work done in November 2019 and my total cholesterol was 293 (normal is less than 199). I started taking cholesterol medication in February 2020. I had blood work done in June 2020 and my total cholesterol was 149, ” Jordan shares. “My LDLs went from 219 to 78! I am so grateful that the medication worked so well and so quickly! It’s a weight lifted off of my shoulders.” Although Jordan no longer limits herself to a strictly vegan diet, she is mindful of what she eats and how it affects her cholesterol. She’s thrilled that her cholesterol is now at a healthy level!
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Population Health Study Goes Statewide and Opens Enrollment
The study could expand to a quarter million people, making Nevada the only state in the U.S. to offer such a program. Las Vegas, Nev. (May 2, 2019) – The Healthy Nevada Project, a first-of-its-kind, community-based population health study combining genetic, clinical, environmental and social data, is expanding enrollment to Las Vegas. The Project aspires not only to offer genetic testing to every Nevadan interested in learning more about their health and genetic profile but ultimately, to develop and expand the Project for communities across the United States to drive positive health outcomes nationwide. Adding 25,000 Study Volunteers in Southern Nevada The Healthy Nevada Project is announcing a statewide expansion – opening 25,000 testing slots in Las Vegas. With southern Nevada welcoming the study, the Healthy Nevada Project will offer no-cost genetic testing through a simple spit sample to 25,000 study volunteers. Study volunteers will take Helix’s clinical-grade DNA saliva test and will receive their ancestry and traits, at no cost, through the My Healthy Nevada Traits app. Participants will then be given a chance to answer a follow-up health survey from Renown Institute for Health Innovation (Renown IHI), and upon survey completion, will be entered to win an iPhone. In addition, study participants can agree to be notified about genetic test results that could impact their health, and which could be used to improve their medical care. This return of clinical results, plus genetic counseling and other genetic services as appropriate, will be provided by Genome Medical, the leading network of clinical genetics specialists. Healthy Nevada Project’s Evolution & Ongoing Expansion With more than 35,000 study participants enrolled in just over two years, the Healthy Nevada Project has become the fastest-enrolling genetic study in the country. The Project was created by Renown IHI – a collaboration between Reno, Nev.-based not-for-profit health network, Renown Health, and the world leader in environmental data, Desert Research Institute (DRI). Leveraging Renown’s forward-thinking approach to community health care and DRI’s data analytics and environmental expertise, Renown IHI has grown its capabilities to lead a larger, more complex research study of significance that will analyze and model public health risks in Nevada and serve as a national model for future population health studies working to improve overall health through clinical care integration. During the Project’s pilot launch in September 2016, more than 10,000 community members signed up for DNA testing in just 48 hours. In March 2018, phase two offered full genomic sequencing through a simple spit test from Helix to northern Nevadans. In October 2018, the Project announced the return of clinical results for study participants, notifying them of their risk for CDC Tier 1 conditions including familial hypercholesterolemia, BRCA positive 1 and 2, and Lynch syndrome, a precursor to colon cancer. These conditions affect more than one percent of the population and are inherited so they impact family members as well. Now, the Project announced its next phase – expanding enrollment to 25,000 people in southern Nevada. Serving as a National Model This expansion to Las Vegas truly makes this the “Healthy Nevada Project” with a statewide impact making Nevada the only state in the U.S. to offer such a program. “Nevada was ripe to advance population health goals because, sadly, our state ranks near the bottom in health outcomes. The Healthy Nevada Project is working to change that,” said Anthony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health and president of Renown IHI. “Our researchers are working on a number of clinical programs and scientific studies to determine why in Washoe County, the county in which Renown Health is located, Nevada’s age-adjusted death rates for heart disease, cancer and chronic lower respiratory disease are 33 percent higher than the national rate. Imagine if we can gather more data like this on a national scale and use it to change the future of health and health care? That is what the Healthy USA Project is looking to do in the years to come.” “The Healthy Nevada Project is committed to providing study participants clinically actionable data that will help improve their health,” said Joseph Grzymski, Ph.D., associate research professor at DRI, principal investigator of the Healthy Nevada Project and chief scientific officer for Renown Health. “We are providing this information at the individual level so study volunteers can make lifesaving changes to reduce their risk. We’re also doing it on the community level to develop leading-edge research on health determinants for entire neighborhoods, states and eventually, the country.” Expanding to Become the Healthy USA Project The accelerated speed of the Project is made possible thanks to the ever-decreasing cost of sequencing. Today, Helix is able to sequence an entire exome – which allows reporting on most actionable genomic knowledge – for a fraction of what it would have cost just 10 years ago. Additionally, advances in digital health mean Helix and Project researchers can capture unprecedented amounts of health data digitally, making significant contributions to advancing precision health. The partnership has managed to remove the traditional barriers of population health studies, including the difficulty in recruiting participants, establishing quality high through put lab systems, and scaling interpretation and return of results. This development will be key as other health systems around the country join the Project. “We are thrilled to see the constant, fast-paced evolution of this Project with Renown IHI,” said Justin Kao, CoFounder of Helix. “In less than a year, we have sequenced the DNA of thousands of study participants and are now preparing to offer this incredible study in other states. Combining environmental, clinical, social and genetic data allows us to discover risk factors within communities and help people take action to live longer, healthier lives. That’s what makes the next step of the Healthy USA Project so exciting for all of us. ”Full details on study’s evolution and southern Nevada enrollment will be revealed at a press event in Las Vegas on Tuesday, May 7 at 3 p.m. Renown Institute for Health Innovation Renown Institute for Health Innovation is a collaboration between Renown Health - a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California; and the Desert Research Institute - a recognized world leader in investigating the effects of natural and human-induced environmental change and advancing technologies aimed at assessing a changing planet. Renown IHI research teams are focused on integrating personal healthcare and environmental data with socioeconomic determinants to help Nevada address some of its most complex environmental health problems; while simultaneously expanding the state’s access to leading-edge clinical trials and fostering new connections with biotechnology and pharmaceutical companies. Learn more at https://healthynv.org/. Helix is a genomics company with a simple but powerful mission: to empower every person to improve their life through DNA. Our affordable, turnkey population health solution enables institutions to quickly scale projects that engage communities and accelerate research and discovery, ultimately allowing every person to benefit from the power of genomics. We've also created the first marketplace for DNA-powered products where people can explore diverse and uniquely personalized products developed by high-quality partners, providing powerful tools to increase engagement and speed the pace of population-scale genomics. Helix is headquartered in the San Francisco Bay Area, has an office in Denver, Colorado and operates a CLIA-certified and CAP-accredited next-generation sequencing lab in San Diego powered by Illumina (NASDAQ: ILMN) NGS technology. Helix was created in 2015. Learn more at www.helix.com. Helix, the Helix logo and Exome+ are trademarks of Helix Opco, LLC. All other trademarks referenced herein are the property of their respective owners. Additional Media Contacts: Tracy Bower DRI 702-862-5404 media@dri.edu Eric Schubert Seismic for Helix 415-939-4366 press@helix.com
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Renown Institute Expands Partnership to Offer ELF Testing
Together, will test over 30,000 qualifying study participants by 2023 for risk of cirrhosis and liver-related illnesses. Renown Institute for Health Innovation (IHI) announced today that the organization and Gilead Sciences, Inc. will be joining forces with Siemens Healthineers to offer the Enhanced Liver Fibrosis (ELF™) Test to people with risks for nonalcoholic steatohepatitis (NASH) enrolled in the Healthy Nevada Project (HNP). The ELF Test will help identify people most at risk for progressing to cirrhosis and liver-related outcomes and allow healthcare providers to intervene before irreparable damage occurs. This noninvasive blood test uses three serum biomarkers to create an ELF score from a predefined algorithm, which can be used by doctors to help evaluate if a patient requires increased medical care and monitoring for their condition. Nonalcoholic fatty liver disease (NAFLD), which includes NASH, is prevalent in Nevada and under-diagnosed, likely affecting more than 500,000 adult Nevadans. If undetected and untreated, NASH can result in liver cirrhosis and may require liver transplantation or lead to death. There are more than 12,000 people on a waitlist for liver transplantation in the U.S. and this number continues to rise due to the increasing prevalence of NAFLD. “Thanks to important data collected through our Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study, we now know that NASH is prevalent in the state of Nevada,” said Tony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health. “We are proud to expand our partnership with Gilead and begin working with Siemens Healthineers to improve health of those with liver disease and to take early detection one step further by offering Enhanced Liver Fibrosis, ELF testing for patients of Renown Health. This test provides our team of highly-skilled physicians an advanced, noninvasive method to actively assess dynamic liver fibrosis in study participants and intervene whenever necessary, contributing to a healthier Nevada.” “Gilead believes that noninvasive tests, including the ELF Test, will help improve the experience of people living with NASH. These tests may help to diagnose liver disease, monitor disease progression and evaluate responses to treatment without the requirement for liver biopsy,” said Rob Myers, MD, Vice President, Liver Fibrosis Clinical Research at Gilead Sciences. “The ELF Test has proven itself to be a valuable tool in NASH management and we hope this partnership will further support its use in routine care.” “We are very pleased that NASH patients in the Healthy Nevada Project now have access to the ELF Test which offers clinically useful prognostic information for their condition with the convenience of a simple blood test. Using our advanced laboratory expertise together with Renown IHI and Gilead, we can work towards better understanding of NASH and liver disease in a representative patient population,” said Sebastian Kronmueller, Head of Molecular Diagnostics at Siemens Healthineers. “We launched the Healthy Nevada Project to help people understand more about their health, to identify serious health risks, and to give people access to innovations like the ELF Test, so they can live their best lives,” said Renown’s chief scientific officer, Dr. Joseph Grzymski, who is also a research professor at the Desert Research Institute and principal investigator of the Healthy Nevada Project. It’s incredibly rewarding to be able to report clinical findings to help our 50,000 volunteer study participants, and to assist healthcare providers in helping their patients.” The provision of the ELF Test builds on a previously announced strategic collaboration between the Renown IHI and Gilead in July 2019. This ongoing partnership aims to collect and analyze de-identified genetic and electronic health data from 60,000 qualifying study participants to enhance the understanding of NAFLD and NASH and to potentially inform development of treatment options for these diseases. About NAFLD and NASH NAFLD is a build-up of fat in the liver of people who do not have a history of alcohol misuse. It is normal for the liver to contain some fat, but if more than 5 percent of the liver content is fat, it’s considered a fatty liver (steatosis). NASH is the most severe form of NAFLD in which a person has liver cell damage and inflammation of the liver. Inflammation and liver cell damage can cause fibrosis, or scarring of the liver, and can cause decreased liver function (1). The symptoms of NASH are often silent or non-specific, making it difficult to diagnose. About one-third of people with NASH develop cirrhosis or irreversible liver damage (2). About the ELF™ Test The ELF Test is a noninvasive blood test that can quickly identify which patients are at an elevated risk for developing cirrhosis and other liver-related clinical events (LREs). In contrast to standard liver enzyme tests that reflect liver damage that has already occurred, the ELF Test combines three serum direct biomarkers of active fibrosis. The ELF Test algorithm measures each of these biomarkers to create an ELF score, which can be used as an aid to assess the risk for future disease progression. Doctors may use this ELF score to help evaluate if a patient requires increased medical care and monitoring for their condition. Individuals interested in determining their risk for NASH and its progression are encouraged to enroll in the Nonalcoholic Steatohepatitis Liver Disease Genome Atlas study. Those who have already consented and participated in the study will be contacted with more information on how to receive an ELF blood test. For more information or to enroll, please contact RenownIHI@renown.org or (775) 982-6914. The Enhanced Liver Fibrosis (ELF™) Test kit is not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements. In the U.S., the ELF Testing Service is available from Siemens Healthcare Laboratory, LLC (SHL), a CLIA-certified laboratory located in Berkeley, Calif. The ELF Testing Service, including the establishment of performance characteristics, was developed by SHL. The ELF Test has not been cleared or approved by the U.S. Food and Drug Administration. SHL is regulated under CLIA as qualified to perform high complexity testing. The ELF Test is used for clinical purposes and should not be regarded as investigational use only or research use only. About Renown Health Renown Health is the region’s largest, locally owned and governed, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California. With a diverse workforce of more than 7,000 employees, Renown has fostered a longstanding culture of excellence, determination and innovation. The organization comprises a trauma center, two acute care hospitals, a children’s hospital, a rehabilitation hospital, a medical group and urgent care network, and the region’s largest, locally owned not-for-profit insurance company, Hometown Health. Renown’s institute model addresses social determinants of health and includes: Child Health, Behavioral Health & Addiction, Healthy Aging and Health Innovation. Clinical institutes include: Cancer, Heart and Vascular Health, Neurosciences and Robotic Surgery. Renown is currently enrolling participants in the world’s largest community-based genetic population health study, the Healthy Nevada Project®. For more information visit, renown.org. About the Renown Institute for Health Innovation Renown Institute for Health Innovation is a collaboration between Renown Health - a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California; and the Desert Research Institute - a recognized world leader in investigating the effects of natural and human-induced environmental change and advancing technologies aimed at assessing a changing planet. Renown IHI research teams are focused on integrating personal healthcare and environmental data with socioeconomic determinants to help Nevada address some of its most complex environmental health problems; while simultaneously expanding the state’s access to leading-edge clinical trials and fostering new connections with biotechnology and pharmaceutical companies. Learn more at healthynv.org. Renown Health is Nevada’s most comprehensive and integrated healthcare network and maintains electronic health records for 1.02 million registered patients. In 2016, Renown Health and the Desert Research Institute established the Healthy Nevada Project (HNP), the nation’s first community-based population health study. In 2017 HNP began a partnership with Helix to leverage its population health services, Exome+™ sequencing, and consumer engagement tools. The HNP is now an ongoing collaboration between Renown IHI, the Desert Research Institute, a global leader in environmental data and applied research, and Helix, a personal genomics company. HNP combines genetic, environmental, social and clinical data to address individual and community health needs with the goal of improving health across the state and the nation. The HNP currently has over 60,000 participants. For more information, visit healthynv.org. About Siemens Healthineers Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of Healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostic, image-guided therapy, and in-vivo diagnostics. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers ability to provide high-quality, efficient care to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers, which has approximately 54,000 employees worldwide, generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Further information is available at www.siemens-healthineers.com.Media Contact for Siemens Healthineers: Lance LongwellM: 610-448-6341E: lance.longwell@siemens-healthineers.com
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