Discovery

University of Vermont Health Network begins offering Genomic DNA Testing

by Luna

Pilot project holds promise for helping inform Vermonters’ health care decisions

BURLINGTON — The University of Vermont Health Network has begun a pilot project to offer Genomic DNA Testing to patients as part of their clinical care. The pilot program is the beginning of an effort to increase the integration of genetic disease risks into routine medical care, which holds promise for providing Vermonters with valuable information to guide their health decisions.

Our overall health and longevity are determined about 30 percent by genetics,” said Debra Leonard, MD, PhD, Chair, Pathology and Laboratory Medicine. “But until now, most of our clinical health care decisions have been made without understanding the differences in each individual’s DNA that could help guide those decisions.”

Patients who choose to get the Genomic DNA Test can learn about differences in their DNA that make certain diseases more likely, such as cancer and heart disease. Knowing these genetically-determined disease risks may help patients and health care providers adjust their care to keep people as healthy as possible. While genetic testing to identify the cause of a patient’s symptoms to reach a diagnosis is now common in health care, proactive genomic testing to identify health risks across a population is just beginning to be considered, and most projects are being done only in the research setting.

The UVM Health Network is partnering with Invitae and LunaPBC on the pilot project. Invitae will provide information for 147 genes that are well-established indicators of increased risk for certain diseases for which clinical treatment guidelines are established. The test also screens for carrier status for other diseases. Follow-up testing for family members will be provided when appropriate.

Nearly 1 in 6 healthy individuals exhibits a genetic variant for which instituting or altering medical management is warranted,” said Robert Nussbaum, MD, Chief Medical Officer of Invitae. “Genetic screening like the Genomic DNA Test in a population health setting can help identify these risk factors so clinicians can better align disease management and prevention strategies for each patient.”

The UVM Health Network is offering the Genomic DNA Test as part of clinical care, but health and genomic data can also help researchers learn more about health and disease. Patients who get the test can consent to securely share their data with researchers through LunaDNA, partner LunaPBC’s sharing platform. LunaDNA provides patients with the opportunity to share their genomic and electronic health record information to advance health and disease management research. In the future, patients will also be able to share lifestyle, environment, and nutrition data. Shared data is de-identified and aggregated during studies to protect the privacy of each patient while being used to answer important medical research questions.

Vermonters who choose to share their genomic data for research will play a leading role in the advancement of precision medicine,” said Dawn Barry, LunaPBC President and Co-founder. “This effort puts patients first to create a virtuous cycle for research that doesn’t sacrifice patients’ control or privacy. We are proud to bring our values as a public benefit corporation and community-owned platform to this partnership.”

Dr. Leonard spoke about the project, the UVM Health Network’s partnership with LunaPBC and Invitae, and the role of genomics in population health on Monday at the Santa Fe Foundation’s Clinical Lab 2.0 Workshop in Chicago, a national conference at which pathologists and healthcare leaders from across the country share ways that pathology can be integral to improving population health.

Vermont and other states are moving away from ‘fee-for-service’ health care and toward a system that emphasizes prevention, keeping people healthy and treating illness at its earliest stages,” Dr. Leonard said. “Integrating genetic risks into clinical care will help patients and providers in their decision-making.”

The pilot project began on Friday, November 1, when the first patient agreed to have the test. During the pilot stage of the project over the next year, the Genomic DNA Test will be offered to approximately 1,000 patients over the next year who: are at least 18 years old; receive their primary care from a participating UVM Health Network Family Medicine provider; are not currently pregnant or the partner of someone who is currently pregnant; and are part of the OneCare Vermont Accountable Care Organization (ACO), a care coordination and quality improvement organization.

Patients do not have to pay for the test or for discussions with the UVM Health Network’s Genomic Medicine Resource Center’s genetic counselors before and after testing. The test uses a small amount of blood, and focuses on the parts of a patient’s DNA that most affect health and health care. Results will go into each patient’s medical record, protected like all medical information, and available to the patient and all of their health care providers.

Much work has gone into getting ready to start this project and it has taken an entire team,” Dr. Leonard said. “Providers from Family Medicine, Cardiology, the Familial Cancer Program, Medical Genetics and Pathology, patient and family advisors, ethics and regulatory compliance leaders, Planning, Finance and OneCare Vermont have all worked together to get us across the start line for this initiative.”

Patients should be aware that the UVM Health Network will never call them on the phone to ask them to get this test. Testing is arranged through a patient’s primary health care provider and only if the patient agrees to have the test.

About The University of Vermont Health Network
The University of Vermont Health Network is an academic health system comprised of six affiliate hospitals, a multi-specialty medical group, and a home health agency. We serve the residents of Vermont and northern New York with a shared mission: working together, we improve people’s lives. Our 4,000 health care professionals are driven to provide high-quality, cost-efficient care as close to home as possible. Strengthened by our academic connection to the University of Vermont, each of our hospitals remains committed to its local community by providing compassionate, personal care shaped by the latest medical advances and delivered by highly skilled experts.

About Invitae
Invitae Corporation (NYSE: NVTA) is a leading genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae’s goal is to aggregate the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company’s website at invitae.com.

About LunaPBC
Public Benefit Corporation, LunaPBC, is a private investor-owned company founded in November 2017. It is chartered to drive societal value through the aggregation and organization of genomic and health data at a scale and diversity rich enough to solve today’s greatest health challenges. LunaPBC founded LunaDNA, the first people-powered, community-owned data sharing platform. The LunaPBC team, investors, and advisors are renowned in the patient-advocacy, health, and science fields, including several former chief executives of Illumina, industry academics, and financial executives. For more information visit www.lunadna.com.

LunaDNA Partners with Genomelink
News

LunaDNA Partners with GenomeLink to Offer Members Even More

by Luna

We’re excited to announce our strategic partnership with Genomelink, the largest and fastest growing web platform that enables members to upload their raw DNA data file and discover more about their DNA identities and traits through intuitive visualization and scientific educational content.

Now, LunaDNA™ members can contribute their DNA data to Genomelink and learn more about their unique health data, from personality traits, fitness and nutrition, and more.

This partnership allows LunaPBC™, manager of LunaDNA, to unite our shared mission with Awakens, creator of Genomelink, and close the gap between individual and researcher by positioning individuals at the center of health discovery. Together, we’re supporting health research, advancing science and accelerating medical breakthroughs.

We are excited to see organizations like Awakens recognizing that modern data stewardship means individuals must come first. People coming together at scale as a data sharing community represents the next frontier in making research more efficient, inclusive, and informative, but it requires earning people’s trust through transparency, reciprocity, and honoring their control at all times.”

Dawn Barry, President + Co-founder at LunaPBC

As LunaDNA’s platform evolves, LunaDNA members will have the ability to earn additional shares by importing their weekly trait data from GenomeLink onto the LunaDNA platform. For now, Awakens invites Genomelink members to participate in the new wave of people-powered health by becoming a pioneering member of LunaDNA and joining a health movement that’s reshaping the traditional health research model.

Awakens believes personal DNA engagement should be a life-long journey for individuals and their families because the knowledge embedded in our DNA is continuously being discovered.”

Tomohiro Takano, CEO + Co-founder at Awakens

This partnership comes just 15 years after DNA Day was officially declared a national holiday, commemorating the day James Watson, Francis Crick, Maurice Wilkins, Rosalind Franklin and colleagues published papers in the journal Nature on the structure of DNA back in 1953. Furthermore, we recognize April 25th as the day when the Human Genome Project was near-completion, with the remaining gaps considered “too costly” to fill. It’s an eventful day in DNA history and we’re thrilled to be celebrating it improving quality of life for all.

About Luna

Luna’s suite of tools and services connects communities with researchers to accelerate health discoveries. With participation from more than 180 countries and communities advancing causes including disease-specific, public health, environmental, and emerging interests, Luna empowers these collectives to gather a wide range of data—health records, lived experience, disease history, genomics, and more—for research.

Luna gives academia and industry everything they need from engagement with study participants to data analysis across multiple modalities using a common data model. The platform is compliant with clinical regulatory requirements and international consumer data privacy laws.

By providing privacy-protected individuals a way to continually engage, Luna transforms the traditional patient-disconnected database into a dynamic, longitudinal discovery environment where researchers, industry, and community leaders can leverage a range of tools to surface insights and trends, study disease natural history and biomarkers, and enroll in clinical studies and trials.

LunaDNA is Approved by the SEC
News

LunaDNA Is Approved By The SEC to Offer Ownership Shares to Individuals for Sharing Data

by Luna

SOLANA BEACH, Calif., Dec. 5, 2018  — LunaDNA LLC announced today that its securities offering has been qualified and its platform is now open to U.S. residents. LunaDNA™ is the first community-owned health and DNA data platform to offer ownership shares for contributing personal health information.

The Final Offering Circular for the offering is available at the U.S. Securities and Exchange Commission (SEC) website here. U.S. residents can sign up at LunaDNA.com to contribute data and obtain shares.

Founded by the Public Benefit Corporation LunaPBC, Inc., LunaDNA’s platform is rooted in putting individuals at the center of health research, with unique features for data privacy, voluntary inclusion, transparency, and sharing in the value created from use of their data. The monetary value of LunaDNA share ownership will be expressed through dividends consistent with an individual’s ownership percentage. Holders of shares can increase their holdings over time by contributing more data, and intrinsic value in the database is created as research advances and medical discoveries are accelerated.

This people-first model is designed to address previous industry research challenges such as data silos limitation, data usage non-transparency, and value imbalance. LunaDNA has created a global community for data sharing where community is the core tenet. Members control their inclusion in the database by always having the option to remove consent and delete their data from the platform.

Nothing is more personal than our health and DNA data. LunaDNA, in a precedent-setting move, is enabling individuals to own shares in the company that monetizes their data. This new data paradigm enables a community to control their continued inclusion, learn about studies undertaken with the database, celebrate discoveries, and participate in the financial rewards that come from commercial partnerships.”

Bob Kain, CEO + Co-founder, LunaPBC™

Researchers from nonprofits, for-profits, disease organizations, and research communities will be able to query the LunaDNA platform for research studies. Members’ de-identified and aggregated health data provided in response to those queries will help power research at the scope and scale needed for medical breakthroughs. While maintaining anonymity and only with consent, LunaDNA members may further opt-in to receive communications from researchers interested in including them in a research study or trial.

Medical breakthroughs and improving quality of life depend on comprehensive, continuous, real-world health data organized to support medical discovery. People are the best curators of their health data, and we need them as partners in research,” said Dawn Barry, president and co-founder, LunaPBC. “This model brings together social responsibility with technology for real-world, frictionless, passive information capture. We can imagine research as a continuous relationship versus a moment in time transaction.”

Beginning today, you can receive shares for contributing eligible data types, including DNA data files from services such as 23andMe, AncestryDNA, and MyHeritage, on the LunaDNA platform.

GET MORE INFO OR VIEW THE FINAL OFFERING CIRCULAR

VIEW OFFERING

About LunaDNA
LunaDNA is the first health and DNA data platform owned by its community of personal health information donors. LunaDNA empowers individuals to share their health data for medical research and the greater good of the community. As community owners in the LunaDNA platform, holders of shares participate in the value created from health discovers and medical breakthroughs.

LunaDNA was created by the privately-owned Public Benefit Corporation LunaPBC, founded in 2017 and headquartered in Solana Beach, California. The LunaPBC team, investors, and advisors are renowned in the patient-advocacy, health, and science fields, including several former chief executives of Illumina, industry academics, and financial executives.

LunaDNA does not provide genetic testing services, as it focuses on aggregating health information that individuals already own to accelerate health research. LunaDNA does not endorse any specific genetic testing company.

Forward Looking Statements
The matters contained in the discussion above may be considered to be “forward-looking statements” within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations or anticipations of LunaDNA and LunaPBC and members of LunaPBC’s management team. Factors currently known to management that could cause actual results to differ materially from those in forward-looking statements include the following: LunaDNA’s ability to attract and retain members; breaches of network security or the misappropriation or misuse of personal and health data; dependence on LunaPBC for funding; market demand for analysis of genomic information and LunaDNA’s ability to recruit researchers to query the database; the need to comply with complex and evolving U.S. and foreign laws and regulations; dependence on third parties to generate data contributed by members; competition; dependence on LunaPBC as manager of LunaDNA, including dependence of key personnel of LunaPBC; the ability of LunaPBC to unilaterally change LunaDNA’s operating agreement and management services agreement; potential for disruption from network outages; failure to maintain the integrity of systems and infrastructure; liabilities as a result of privacy regulations; failure by LunaPBC to adequately protect intellectual property rights or allegations of infringement of intellectual property rights; the general non-transferability of shares and the lack of a trading market for the shares; uncertainty in the ability of LunaDNA to earn sufficient revenue, after expenses, to have sufficient funds to pay dividends to holders of shares; the discretion of LunaPBC as to the declaration of dividends on the shares; lack of voting rights and other typical shareholder rights; potential adverse effects of LunaPBC’s conflicts of interest; and the limited recourse of LunaDNA share holders against LunaPBC for its actions as manager. These and additional factors to be considered are set forth under “Risk Factors” in LunaDNA’s Final Offering Circular and in its other filings with the Securities and Exchange Commission. LunaDNA undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results or expectations, except as otherwise required by law.

Genetic Alliance and LunaPBC Partner
News

Genetic Alliance and LunaPBC Partner to Support Personal Health and Accelerate Medical Breakthroughs

by Luna

SOLANA BEACH, Calif., Jan. 22, 2019 — LunaPBC™, founder of LunaDNA™, the first community-owned genomic and health data platform, announced today its partnership with Genetic Alliance, a non-profit dedicated to providing ordinary people with powerful tools to transform research. Over the course of 2019, the organizations will merge Genetic Alliance’s Platform for Engaging Everyone Responsibly engagement platform with LunaDNA to provide individuals and communities with more resources to support health management while maximizing research opportunities.

Genetic Alliance Logo

The partnership enables LunaPBC and Genetic Alliance to unite their shared mission and technologies to create seamless solutions to support individuals, disease foundations, and patient advocacy organizations while also powering disease research at scale. Shared values across both organizations will ensure the ongoing focus of honoring a person’s preferences and rights for data transparency, privacy, and control while accelerating science and creating shared value.

In December 2018, LunaDNA received precedent-setting approval from the U.S. Securities and Exchange Commission (SEC) to recognize an individual’s health data as currency with which to acquire shares of ownership in the company. Researchers from nonprofits, for-profits, disease organizations, and research communities can request access to the LunaDNA platform to conduct research studies. LunaDNA members’ de-identified, aggregated, and encrypted health data helps power research at the scope and scale needed for medical breakthroughs.

The joining of Genetic Alliance’s patient outreach and engagement with LunaDNA’s person-centered data management expertise takes advantage of both organizations’ exceptional strengths. This will accelerate the research opportunities afforded by rich, longitudinal data, and a cohort of research-aware participants and has the potential to change the clinical research paradigm and how participants are connected to clinical trials,” said Michelle Penny, co-chair of the National Academies of Sciences, Engineering and Medicines Roundtable on Genomics and Precision Health.

Genetic Alliance’s Platform for Engaging Everyone Responsibly (PEER) is an award-winning technology solution for collecting health data directly from individuals. The platform gives individuals complete control over how their data is shared for research. Organizations and communities interested in using PEER to collect individual health data for a specific purpose do so by creating customized registries. PEER participants will join the LunaDNA community and be invited to receive ownership shares in LunaDNA when contributing their personal health information. Dividends from shares may be donated to charitable organizations of the individual’s choosing. Currently, PEER is used by 45 disease communities representing more than 50,000 individual participants. The Genetic Alliance network includes more than 1,200 disease-specific advocacy organizations, as well as thousands of universities, private companies, government agencies, and public policy organization. In 2015, PEER was honored by the White House as one of nine leading platforms in the advancement of precision medicine.

Most research endeavors leave out the most critical stakeholder: people. While health data is a critical component to the advancement of new treatments, research, and medical technology, data alone will not lead to solutions that alleviate suffering. The biomedical research enterprise tries to cut corners and sever people’s connection to their data, or keep it opaque how individual health data is used and who gains access to the data individuals provide. We are excited to partner with LunaPBC because, like us, they believe individuals need and deserve opportunities to be active participants in their own health and research opportunities. The day of de-identified data is over – we need to understand what happens over time, we need people to be partners in their own research to care cycle. Together, we’re providing a people-centric model that empowers the individual to offer access to their health data and also receive support. We are building secure and transparent communities and connections geared towards supporting the individual that will accelerate medical breakthroughs,” said Sharon Terry, president and CEO, Genetic Alliance.

“By putting people truly at the center of the model versus just leveraging them as sources of specimens, we engage individuals as true partners in creating a dynamic, real world asset for research. Rather than having researchers wait for sufficient data to pose questions, the community-owned data is poised to address their novel hypotheses. The opportunity to reshape research and be inclusive is good for both people and discovery,” said Dawn Barry, president and co-founder, LunaPBC.

About Genetic Alliance
Genetic Alliance, a non-profit organization founded in 1986, is a leader in deploying high tech and high touch programs for individuals, families and communities to transform health systems by being responsive to the real needs of people in their quest for health. The alliance is comprised of 10,000 organizations, 1,200 of which are disease and patient advocacy foundations and include community health programs, employee wellness programs, local nonprofits, religious institutions, and community-specific programs to grow and expand their reach and mission.

About LunaDNA
LunaDNA is the first health and genomic data platform owned by its community of personal health information donors. LunaDNA empowers individuals to share their health data for medical research and the greater good of the community. As community owners in the LunaDNA platform, members share in the value created from health discoveries and medical breakthroughs.

LunaDNA was created by the privately-owned Public Benefit Corporation, LunaPBC, founded in 2017 and headquartered in Solana Beach, California. The LunaPBC team, investors, and advisors are renowned in the patient-advocacy, health, and science fields, including several former chief executives of Illumina, industry academics, and financial executives.