Renown Institute Expands Partnership to Offer ELF Testing
15 de diciembre de 2020
Juntos, realizarán pruebas a más de 30,000 participantes del estudio elegibles antes de 2023 para determinar el riesgo de cirrosis y enfermedades relacionadas con el hígado.
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.
La enfermedad de hígado graso no alcohólico (EHGNA), que incluye la EHNA, es frecuente en Nevada y está subdiagnosticada, y probablemente afecte a más de 500,000 adultos en nuestro estado. If undetected and untreated, NASH can result in liver cirrhosis and may require liver transplantation or lead to death. Hay más de 12,000 personas en la lista de espera para trasplante de hígado en los EE. UU. y esta cifra continúa aumentando debido al incremento en la prevalencia de la EHGNA.
“Gracias a datos importantes recopilados a través de nuestro estudio ‘Atlas genómico de la esteatohepatitis hepática no alcohólica’, sabemos ahora que la EHNA es prevalente en el estado de Nevada”, afirmó Tony Slonim, MD, DrPH, FACHE, presidente y director ejecutivo de 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.
“Lanzamos el Healthy Nevada Project para ayudar a las personas a comprender más sobre su salud, identificar riesgos de salud graves y brindarles acceso a innovaciones como la prueba de ELF, para que puedan llevar la mejor vida posible”, dijo el director científico de Renown, el Dr. Joseph Grzymski, que también es profesor de investigación en el Desert Research Institute e investigador principal del Healthy Nevada Project. Es increíblemente gratificante poder informar hallazgos clínicos para ayudar a nuestros 50,000 participantes voluntarios del estudio y asistir a los proveedores de atención médica a ayudar a sus pacientes”.
La provisión de la prueba de ELF se basa en una colaboración estratégica anunciada previamente entre el Renown IHI y Gilead en julio de 2019. Esta asociación en curso tiene como objetivo recopilar y analizar datos de salud genéticos y electrónicos anónimos de 60,000 participantes del estudio elegibles con el fin de mejorar la comprensión de la EHGNA y la EHNA, y para potencialmente orientar el desarrollo de opciones de tratamiento para estas enfermedades.
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. Es normal que el hígado contenga algo de grasa, pero si más del 5 por ciento del contenido hepático es grasa, se considera hígado graso (esteatosis). NASH is the most severe form of NAFLD in which a person has liver cell damage and inflammation of the liver. La inflamación y las células hepáticas dañadas pueden causar fibrosis, o cicatrización del hígado, y disminución de la función hepática (1). The symptoms of NASH are often silent or non-specific, making it difficult to diagnose. Aproximadamente, un tercio de las personas con EHNA desarrollan cirrosis o daño hepático irreversible (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. Para obtener más información o para inscribirse, comuníquese a la casilla de correo RenownIHI@renown.org o al teléfono (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.
Acerca de 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. Con una fuerza laboral diversa de más de 7,000 empleados, Renown ha fomentado una cultura de excelencia, determinación e innovación de larga data. La organización se compone de un centro de urgencias, dos hospitales de cuidados agudos, un hospital infantil, un hospital de rehabilitación, un grupo médico y una red de atención de urgencias y Hometown Health, la compañía de seguros sin fines de lucro más grande de la región y de propiedad local, 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. Actualmente, Renown está inscribiendo participantes en el estudio genético de salud poblacional basado en la comunidad más grande del mundo, el Healthy Nevada Project®. Para obtener más información, visite 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. Obtenga más información en healthynv.org.
Renown Health es la red de atención médica más completa e integrada de Nevada y mantiene registros médicos electrónicos para 1.02 millones de pacientes registrados. En 2016, Renown Health y el Desert Research Institute crearon el Healthy Nevada Project (HNP), el primer estudio de salud poblacional basado en la comunidad del país. En 2017, el HNP comenzó una sociedad con Helix para aprovechar sus servicios de salud poblacional, la secuenciación Exome+™ y las herramientas de participación del consumidor. El HNP ahora es una colaboración continua entre el Renown IHI, el Desert Research Institute, líder global en datos ambientales e investigación aplicada, y Helix, una empresa de genómica personal. 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. El HNP actualmente tiene más de 60,000 participantes. Para obtener más información, visite healthynv.org.
About Siemens Healthineers
Siemens Healthineers AG (cotizada en la bolsa de Frankfurt, Alemania: 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. En el año fiscal 2020, que finalizó el 30 de septiembre de 2020, Siemens Healthineers, que tiene aproximadamente 54,000 empleados en todo el mundo, generó ingresos por €14.5 mil millones y un EBIT ajustado de €2.2 mil millones. Encontrará más información disponible enwww.siemens-healthineers.com www.siemens-healthineers.com.
Media Contact for Siemens Healthineers: Lance Longwell
M: 610-448-6341
E: lance.longwell@siemens-healthineers.com
Media Contacts
Renown Public Relations
M: 775-691-7308
Siemens Healthineers
C: Lance Longwell
M: 610-448-6341
Media Contacts
Renown Public Relations
M: 775-691-7308
Siemens Healthineers
C: Lance Longwell
M: 610-448-6341