Faster, Better Testing For COVID; Physician Researchers At Renown Health And UNR Med Seek Convalescent Plasma Study Participants
Physician researchers seek to understand how the immune system responds to COVID-19 and create a healthier Nevada. During the early stages of the pandemic, convalescent plasma was considered the only viable treatment option available for patients with COVID-19. Convalescent plasma is the component of the blood from recovered patients that may contain COVID-19 antibodies that help fight the infection. The National Institutes of Health has since developed treatment guidelines for COVID-19 based on clinical trial data and many studies are still underway worldwide assessing various additional treatment options. Convalescent plasma was in high demand but difficult to locate for COVID-19 patients in the northern Nevada area. A 24-year-old nursing assistant, Austin Meegan, was hospitalized and spent weeks staving off kidney and lung failure before learning he was eligible for an experimental blood transfusion that showed promise in treating COVID-19. Doctors estimated Meegan had only about a 3% chance of tracking down a donor to match his rare blood type. A COVID-19 survivor, Thomas Gibson, a Texas resident with the same blood type, traveled to Reno to donate his viral antibodies and a convalescent plasma donation credited with helping to save Meegan’s life. Physician clinical researchers and scientists at Renown and the University of Nevada, Reno School of Medicine (UNR Med) knew they needed to create better options for patients and physicians. Clinical researchers developed a study to help other patients like Austin, and pleaded for donations from recovered COVID-19 patients to donate their convalescent plasma. The researcher teams looked to understand how the body’s immune system responds to the virus over time, to aid them in developing new treatments for COVID-19. “The world’s capacity to get through the COVID crisis will depend on four things — science, technology, innovation and partnerships, says Tony Slonim, MD, DrPH, President and CEO of Renown Health. “Taking lab bench discoveries to the bedside of patients in an efficacious and timely manner is not easy, but with UNR Med and our partners, we are making great strides in advancing clinical research which has the power to save lives and to create a healthier Nevada.” “It’s tremendously promising to partner on clinical research that will not only help us better understand the disease, but help inform treatment for those combatting COVID-19 that has had such a devastating impact on Nevadans, our nation and the world,” says UNR Med Dean Thomas L. Schwenk, MD. Renown, UNR Med and other area health care partners collaborated with Vitalant to collect plasma from recovered donors for a study on the treatment's efficacy. Eligible donors are at least 18 years old, weigh more than 110 pounds and are healthy. Donors had fully recovered from a confirmed diagnosis of COVID-19. Project coordinators at the Renown Research Office were overwhelmed by the community’s support and plasma blood donations. Additional partnerships with the Washoe County Health District, the State of Nevada and the Governor’s office, Saint Mary’s Medical Center, Northern Nevada Medical Center, Carson Tahoe Health and the VA Sierra Nevada Health Care System, along with many area health care providers helped the team meet their goals of enrolling 120 eligible participants in the study. “Our success in this study rests heavily on the support of our great community, as well as the innovation and collaboration demonstrated by Renown and UNR Med,” said Sara Healy, MD, MPH, principal investigator of the study and a pediatric infectious disease physician at Renown Children’s Hospital and UNR Med. “We are proud to be at the forefront of conducting essential research during such a pivotal time in history, and look forward to our continued partnership as we continue this important work.” “The control of COVID-19 in our communities relies on testing. The study that is being launched to develop a sensitive, specific and easier way to collect specimens (blood) is advancing the field and brings promise towards getting to our common goal of having the right diagnostic test for the right clinical situation at the right time,” says Mark Riddle, MD, DrPH, FISTM, associate investigator of the study and associate dean for clinical research and professor at UNR Med's Department of Internal Medicine and Medical Research. The research team is now asking area residents to participate in a study to analyze the efficacy of two COVID-19 tests. Participants will undergo two blood tests: one being a finger stick to provide results for a rapid test, and the other is a traditional venipuncture draw confirming the presence or absence of COVID-19 antibodies. This study is a collaboration with InBios International, Inc., a leading biotechnology company based in Seattle. Researchers are seeking: Individuals who have confirmed positive for COVID-19 and who have recently recovered from the virus. Study participants must be within 7-28 days from the onset of their symptoms. Individuals who have recently tested negative for COVID-19 and have never tested positive. Those who are interested in participating in the study may contact project coordinators at the Renown Research Office at (775) 982-3646, or via e-mail at firstname.lastname@example.org, 7:30 A.M. – 5:00 P.M., Monday through Friday. Individuals aged 18-75 in general good health are encouraged to consider participating in this ongoing study. There is no cost to participate in this study and participation is voluntary. An individual’s decision to participate will not affect their current or future relations with their health care provider(s), health district, or the community. Those who decide to participate are free to withdraw at any time. “Time is of the essence with COVID. If we can get test results to people and their clinicians in a more timely way, we can make a faster diagnosis of a patient's condition, says Christopher M. Kozlowski, MD, MHA, Renown's institutional research officer and Medical Director/VP of Renown Institute for Heart & Vascular Health. “As we refine the accuracy of our testing; we are applying sensitivity and specificity testing for true negative and true positive results. This provides people with more timely and accurate results and better quality care.” About Renown Health Renown Health is a locally governed, not-for-profit integrated healthcare network serving northern 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 has a long tradition and commitment to improve the care and the health of our community. About the University of Nevada, Reno School of Medicine The University of Nevada, Reno School of Medicine (UNR Med), Nevada’s first medical school, is a community-based, research-intensive medical school with a statewide vision for a healthy Nevada. Established in 1969, UNR Med is improving the health and well-being of all Nevadans and their communities through excellence in student education, postgraduate training and clinical care, research with local, national and global impact and a culture of diversity and inclusion. For more information, visit med.unr.edu.
Healthy Nevada Project’s community-based approach reveals up to 90% of CDC Tier 1 genetic condition risks missed using clinical care guidelines. In a new study published today in the journal Nature Medicine, researchers behind the Healthy Nevada Project® suggest that community-based genetic screening has the potential to efficiently identify individuals who may be at increased risk for three common inherited genetic conditions known to cause several forms of cancer and increased risk for heart disease or stroke. In 2018, the Healthy Nevada Project® (the largest, community-based population health study combining genetic, clinical, environmental and social data) started notifying consenting study participants who have certain genetic variants which predispose them to the Centers for Disease Control and Prevention (CDC) Tier 1 genetic conditions. The study focused on identifying carriers of these conditions, which include Hereditary Breast and Ovarian Cancer, Lynch Syndrome, and Familial Hypercholesterolemia, because they are the most common conditions and early detection and treatment could significantly lower morbidity and mortality. Initial results from almost 27,000 study participants showed that 90% of carriers of the CDC Tier 1 genetic conditions were not previously identified in a clinical setting. The authors conclude that population genetic screening would identify at-risk carriers not identified during routine care. “Our first goal was to deliver actionable health data back to the participants of the study and understand whether or not broad population screening of CDC Tier 1 genomic conditions was a practical tool to identify at-risk individuals,” explained Joseph Grzymski, Ph.D., the principal investigator of the Healthy Nevada Project®, a research professor at the Desert Research Institute (DRI), chief scientific officer for Renown Health and lead author of the study. “Now, two years into doing that, it is clear that the clinical guidelines for detecting risk in individuals are too narrow and miss too many at risk individuals.” Within the group of 26,906 Healthy Nevada Project® participants that Grzymski’s research team studied, 358 (1.33%) were carriers for CDC Tier 1 conditions. However, only 25% of those individuals met clinical guidelines for genetic screening. Additionally, more than 20% of the carriers already had a diagnosis of disease relevant to their underlying genetic condition. “We’re at a point now where it’s possible to do clinical-grade genetic screening at population-scale,” added James Lu, M.D. Ph.D., co-founder and chief scientific officer of Helix and senior co-author of the study. “What this study demonstrates is the potential impact of doing so. By making genetic screening available more broadly, we can help the millions of Americans who are unaware that they are living at increased risk for highly actionable, genetic conditions take action.” Most notably, the study found that of the 273 participants who were carriers of the CDC Tier 1 genetic conditions and had clinical record information, only 22 individuals showed any previous suspicion of their underlying genetic conditions. “For the first time, we are providing information at the individual level so study participants can make lifesaving changes to reduce their risk based on their genetics,” said Anthony Slonim, M.D., Dr.PH., FACHE, president and CEO of Renown Health and co-director of the Project® study. “We’re conducting research on the community level to develop leading-edge research on health determinants for entire neighborhoods, states and eventually, the country. Returning these results allows us to understand the prevalence of genetically programmed diseases and illnesses that we have here in Nevada and ensure we are providing the best prevention and care plans. For the individual, the return of results can be life changing.” According to the CDC, early detection and intervention of the Tier 1 genetic conditions could have a meaningful potential for clinical action ability and a positive impact on public health. The Healthy Nevada Project®, which launched in 2016, offers free genetic testing to every Nevadan, aged 18 and older, interested in learning more about their health and genetic profile. With more than 50,000 study participants enrolled in four years, the Healthy Nevada Project® has become the fastest-enrolling genetic study in the world. For more about 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. Helix is the leading population genomics company operating at the intersection of clinical care, research, and genomics. Its end-to-end platform enables health systems, life sciences companies, and payers to advance genomic research and accelerate the integration of genomic data into clinical care. Powered by one of the world's largest CLIA / CAP next-generation sequencing labs and its proprietary Exome+Ⓡ assay, Helix supports all aspects of population genomics including recruitment and engagement, clinically actionable disease screening, return of results, and basic and translational research. In response to the COVID-19 public health crisis, Helix has launched a sensitive and scalable end-to-end COVID-19 test system to meet the needs of health systems, employers, governments, and other organizations across the country. Learn more at www.helix.com.
Presented by the Desert Research Institute and Renown Health, DANA will help people learn more about the Healthy Nevada Project® and their own unique, genetic health traits What is the Healthy Nevada Project®? What are the benefits of joining this research study? How can I find out if I carry genes for health risks like heart disease, hereditary breast and ovarian cancer syndrome and Lynch syndrome? What if a holographic avatar, powered by artificial intelligence (AI), could answer all these questions and more? DANA has all the answers, she is a virtual assistant with “DNA” in her name, presented by the Renown Institute for Health Innovation (Renown IHI), a collaboration between Renown Health and the Desert Research Institute (DRI). This life-sized, holographic avatar will greet individuals outside Renown Regional Medical Center’s Sierra Café, and talk to them about the Healthy Nevada Project, the world’s largest community-based genetic population health study. Members of the media are invited to meet DANA this morning from 10 a.m. – noon. Please reply to this email or call (775) 691-7308 to coordinate a meet and greet. “Unfortunately, Nevada ranks among the lowest in the nation for health outcomes—and we are working to change that,” said Anthony Slonim, M.D., D.Ph., president and CEO of Renown Health and president of Renown Institute for Health Innovation. “Through the Healthy Nevada Project® , our goal is to offer genetic testing to every Nevadan interested in learning more about their health and genetic profile. Thanks to this advanced technology, DANA will offer people a personalized explanation of the Project, and help them take the next step to better understand their health, and their health risks, so they can modify their behavior and ultimately, live a healthier, happier life.” With more than 51,000 study participants enrolled to date, the Healthy Nevada Project® is considered 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. Furthermore, participants can choose to share their information with their medical provider to improve and enhance their medical care. “We are always happy to engage with our study participants and look forward to having them meet and engage with DANA,” said Joseph Grzymski, Ph.D., research professor at DRI, principal investigator of the Healthy Nevada Project® and chief scientific officer for Renown Health. “At a time of physical distancing and limiting human contact where possible, using tools like an avatar and AI are important for communicating, whether it be for genetics, vaccinations or other important health information.” Visitors can interact with DANA through a touch screen (cleaned and sanitized after every encounter) to learn more about the study, enter their contact information and schedule an appointment to join the free genetics study or receive more information about their test results. Kiosk visitors are asked to maintain physical distance guidelines and use the hand sanitizer and Sani Wipes available next to the kiosk. 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