Renown Institute For Health Innovation Expands Partnership With Gilead Sciences And Siemens Healthineers To Offer ELF - Enhanced Liver Fibrosis Testing For Nevada NASH Study Participants
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: firstname.lastname@example.org
Read More About Renown Institute For Health Innovation Expands Partnership With Gilead Sciences And Siemens Healthineers To Offer ELF - Enhanced Liver Fibrosis Testing For Nevada NASH Study Participants
The Healthy NV Project® launches a new study to identify how private well water could impact the health of those living in the household. You use your faucet to wash your hands, make coffee and fill your water bottle. However, for approximately 41,000 people in Washoe and Churchill Counties who rely on private well water, there may be unseen contaminants present in their H2O, which could be affecting their health. The Healthy Nevada Project®, with support from the National Institutes of Health (NIH), is launching a new study to discover how private well water quality impacts the health of well owners. By providing free water testing kits to interested Healthy Nevada Project® participants, researchers will collect samples and give results back to well owners, along with resources for potential treatment options. Data from previous studies in Nevada show elevated concentrations of heavy metals in some private, household wells. Since water from household wells is not monitored for quality by government agencies, well water testing helps ensure water does not contain dangerous levels of heavy metals, such as lead, which can lead to adverse health impacts. Those with a household well interested in receiving a free water testing kit must be enrolled in the Healthy Nevada Project’s population genetic screening study and consent to be a part of further research. People interested in joining the study can simply sign up to receive a genetic spit test kit in the mail or join the waitlist to be notified when in-person testing resumes. “The goals of the Healthy Nevada project are to improve population health and better understand processes that increase disease risks, such as cancer. In this study, we engage with our study participants and inform them about the impact of the environment on their health, while researching environmental contaminants that may elevate cancer risk,” said Joseph Grzymski, Ph.D., research professor at DRI, principal investigator of the Healthy Nevada Project® and chief scientific officer for Renown Health. “During a time where people are spending more time at home, we’re excited to launch this multi-disciplinary study that dives into possible health impacts of a household’s water source.” “As the Healthy Nevada Project continues to serve over 54,000 research volunteers, we are proud to provide helpful information to participants, so they can make life-changing improvements to their home environment,” said Tony Slonim, M.D., DrPH, FACHE, president and CEO of Renown Health and co-director of the Healthy Nevada Project. “This allows every person with well water in Nevada, to have important information, at no charge, to help live healthier and better lives and to protect their family’s health.” The Healthy Nevada Project® is the fastest-enrolling genetic study in the country. The Project is also the first of its kind to return clinical results to study volunteers, which means participants can learn their genetic risks tied to heart disease and certain cancers, as well as lifestyle changes that could potentially help reduce their risk and prevent disease. To enroll in the Healthy Nevada Project, please visit healthynv.org. 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.
Gilead Sciences And Renown Institute For Health Innovation Announce Strategic Collaboration To Advance Understanding Of Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences, Inc. (Nasdaq: GILD) and the Renown Institute for Health Innovation (IHI) today announced a strategic collaboration to collect and analyze genetic and electronic health data that can enhance the understanding of nonalcoholic steatohepatitis (NASH) and potentially inform development of treatment options for the disease. Under the terms of the collaboration and license agreement, Gilead will provide funding to Renown IHI to sequence and analyze the DNA of 15,000 individuals living with NASH or nonalcoholic fatty liver disease (NAFLD) as well as a control cohort of 40,000 individuals in Nevada. “Combining the sequencing of protein coding DNA, with extensive electronic health record data will enable a deep analysis of the roles of genetics and environment in NASH incidence and progression,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “The analysis of these large datasets in collaboration with Renown IHI could help identify genetic variants that impact the risk of developing NASH and thereby advance the discovery and development of new treatments for this disease.” 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 40,000 participants. “Combining genetic sequencing with large sets of data can play a critical role in understanding and identifying serious health risks, including diseases like NASH. We are excited to collaborate with Gilead to better understand the condition and its complexities,” said Anthony Slonim, MD., DrPH. “Any genetic variants identified in participants through the collaboration may be shared with the participants for patient care purposes.” About NASH Nonalcoholic steatohepatitis (NASH) is a chronic form of liver disease characterized by excess fat in the liver, inflammation, and liver cell damage. Inflammation and liver cell damage can cause scarring of the liver, or fibrosis, and ultimately lead to cirrhosis or liver cancer. NASH is more common in people with certain conditions, including obesity and type 2 diabetes. There are currently limited approved treatments for patients living with NASH. About Gilead Sciences Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com. About Renown Health Renown Health is a locally governed and locally owned, not-for-profit integrated healthcare network serving Nevada, Lake Tahoe and northeast California. Renown is one of the region’s largest private employers with a workforce of more than 7,000. It comprises three acute care hospitals, a rehabilitation hospital, the area’s most comprehensive medical group and urgent care network, and the region’s largest and only locally owned not-for-profit insurance company, Hometown Health. Renown Health’s commitment has extended beyond traditional health care to include community health and well-being. Renown Health works to improve health care through science, research and genetics; forge community partnerships that improve lives and develop innovative models that are improving health care in Nevada. For more information, visit renown.org and follow Dr. Tony Slonim on Twitter @RenownCEOTonyMD. About Helix Helix’s mission is to empower every person to improve their life through DNA. Helix is accelerating the integration of genomic data into clinical care and broadening the impact of large-scale population health programs by providing comprehensive expertise in DNA sequencing, bioinformatics, and individual engagement. Powered by their proprietary Exome+™ assay—a panel-grade exome enhanced by more than 300,000 informative non-coding regions—Helix offers health systems a scalable solution which enables the discovery of medically relevant, potentially life-saving, genetic information. Additionally, Helix offers a suite of DNA-powered products for continued individual engagement and discovery. Helix is headquartered in the San Francisco Bay Area and has one of the world’s largest CLIA-certified, CAP-accredited Next Generation Sequencing labs, located in San Diego, California. Learn more at www.helix.com. Helix, the Helix logo, and Exome+ are trademarks of Helix Opco, LLC Gilead Forward-Looking Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the parties may not realize the potential benefits of this collaboration, and Gilead may fail to discover, develop and commercialize any product candidates for the treatment of NASH. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.Additional Media Contact:Sung Lee, Investors 650-524-7792Arran Attridge, Media 650-425-8975