LunaDNA Team Movember

How Health Movements Build Awareness for Social Good


As a 20+ year veteran in advertising, it’s no easy feat to show attribution between awareness, engagement and action — whether in the act of purchase, donation or advocacy. But something as simple as hair is capable of cutting through the BS, sparking a conversation, and creating a dialogue that’s become a bastion of hope for many deadly diseases.

Too often people are falsely confident about their health history or outcomes. Men, in particular, are hesitant to undergo predictive or preventive measures that are not commonly talked about — like taking a DNA test or getting an annual check up — to identify baseline biomarkers or health indications. As a result, fathers, partners, brothers and friends are experiencing health crises, some even life-threatening.

In the last decade, there has been a rise in consumer products and services that have brought more attention to the health challenges men face. For Hims, a San Francisco-based personal care brand for men, highlights previously-taboo issues men face — like erectile dysfunction, premature ejaculation and hair loss — and empowers men to feel comfortable about seeking treatment. The brand has been able to tap into the male psyche of anonymity + awareness = action. And this is not the only successful model.

For Hims Home Page
For Hims Home Page

Global Mo-vements for the Greater Good of Men

Another empowering health movement has broken barriers for men’s health challenges by reintroducing the power of hair. Gentlemen, that normally are clean shaven are taking great pride to grow, groom and coiffure their moustaches and beards. This phenomenon has created a global “mo-vement” of hairy men and brave associates worldwide striving to encourage hair growth in return for conversation and action.

Movember is an annual event that invites participants to grow their moustaches during the month of November to raise awareness about men’s health issues, such as anxiety, prostate cancer, testicular cancer, and men’s suicide. Similarly, No-Shave November invites participants to forgo shaving and grooming beyond their moustaches to evoke conversation and raise cancer awareness.

According to the US Movember.com, 1 in 9 men will be diagnosed with prostate cancer in the US. Research studies and papers have shown that threshold changes in PSA levels can help identify early onset prostate cancer and lead to interventions and treatments. And events like Movember and No-Shave have brought public awareness to these facts and figures.

LunaDNA No-Shave November Team 2019
The LunaPBC No-Shave November 2019 Team from top left to bottom right: Genevieve Lopez, Mike Fennessy, Kevin Brennan, James White, Alex Leonidova,Tommy Rodriguez, Sanjay John, David Latuno.

How Action Leads To Cure

The success of Movember goes beyond evoking important conversation and building awareness. The health movement has funded more than 1,250 men’s health projects across more than 20 countries. It’s funded the research and medical studies that have discovered the genetic “fingerprint” within men’s prostate cancer cells which will help build a more tailored treatment plan and eliminate over-treatment and side effects.

Another example is a San Diego non-profit, Padres Pedal, a community of cancer fighters, including survivors, families, children, doctors and researchers, who participate in a one-day cycling, running, and stationary bike event to raise funds for local cancer research. This year almost 3,000 people, including me and the LunaDNA team, are participating and have collectively raised ~$2M dollars to help fight for a world without cancer.

Padres Pedal the Cause 2019
Padres Pedal the Cause 2019

In just six years, Padres Pedal the Cause has donated more than $10 million dollars to fund collaborative discovery research at the best cancer institutions in San Diego. Scientists at Moores Cancer Center at UC San Diego Health, Salk Institute for Biological Studies, Rady Children’s Hospital-San Diego, and Sanford-Burnham Prebys Medical Discovery Institute have initiated 48 translational cancer research projects and 5 clinical trials for all types of cancers, including pancreatic, breast, brain, pediatric, skin, lung, colorectal, gastrointestinal, ovarian, and endometrial.

If you cannot actively participate in the event, you can also donate to those who are, like me and the LunaDNA team, riding countless miles on Saturday, November 16.

Luna is bringing together individuals, communities, and researchers to better understand life. The more we come together to contribute health data for the greater good, the quicker and more efficient research will scale, and improve the quality of life for us all.  

Directly drive health discovery by joining the Tell Us About You study. 


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.


JAMES WHITE

VP EXPERIENCE + MEMBER ENGAGEMENT


UVMHN LunaDNA

University of Vermont Health Network begins offering Genomic DNA Testing


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.


How Precision Medicine is Changing Clinical Trial Recruitment

How Precision Medicine is Changing Clinical Trial Recruitment

By Elizabeth Whittington, LunaDNA Contributor


When President Barack Obama introduced “precision medicine” in his 2015 State of the Union, many in the medical field were already familiar with the term. But for the general public, the Precision Medicine Initiative sparked a new way of thinking about disease treatment and prevention; one that takes into account an individual’s genes, environment, and lifestyle.

In just a few years, precision medicine has changed not only the way we treat and prevent diseases, it has also changed the way research scientists think about drug development and clinical trials. By diving into the causes of certain diseases, scientists have found that many are multifactorial. A one-size-fits-all treatment approach rarely works. The age of blockbuster drugs has been replaced with targeted therapies. And clinical trials that test these new types of treatments are getting an overhaul too.

The precision problem in clinical trial recruitment

The traditional clinical trial process follows a lengthy and expensive path, from preclinical laboratory work to increasingly larger clinical trial phases that may study treatment safety, dosage, and effectiveness. But as common diseases are stratified into more narrow subpopulations, that model is becoming unrealistic.

Clinical trial participation in the U.S. has traditionally been very low. Current figures estimate that less than 5 percent of cancer patients enroll in clinical trials. So it’s not surprising that about 40 percent of cancer clinical trials are believed to close before completion merely because researchers cannot accrue enough participants.

In the age of precision medicine, clinical trial participants must meet a precise list of requirements, such as having a certain subtype of disease or a specific genetic mutation.

To overcome these challenges, the research field is now looking at clinical trial recruitment proactively. Instead of recruiting for patients after a lengthy study design, researchers are directly asking the public to provide their health data as clinical trials roll out.

Partnering with advocacy groups

It’s a strategy Sharon Terry is already very familiar with. In the 1990s, when her two children were diagnosed with a rare genetic disorder that doctors knew little about, she conducted her own research to discover the genetic cause, and subsequently developed diagnostic testing, clinical trials, and a biorepository to hold biological samples.

Today some organizations, such as the Cystic Fibrosis Foundation, maintain biorepositories, in which scientists can query the data to find new discoveries. These nonprofits may also allow researchers to recruit clinical trial participants from their communities with approval.

“This allows the individuals themselves to raise their hands to be involved in research,” says Terry, who now heads Genetic Alliance, an advocacy organization that hosts patient communities and a biobank to aid in medical research.

Clinical trial recruitment creativity

Pharmaceutical companies, study investigators, and medical research institutions are now reaching out to nonprofit and advocacy organizations in unique ways to recruit for highly specialized clinical trials.

“I think the common conditions have the opportunity to learn a lot from us rare diseases because we’ve always dealt with small populations,” Terry says, especially when a non-profit group is filled with empowered patients who want to advance medical research.

Nonprofit organizations were founded on the goals of providing resources and emotional support, and raising awareness of a particular disease to the general public, especially rare diseases. Many quickly evolved into activism, lobbying, and research funding. The next evolution is having a direct impact in medical research through education on precision medicine, research funding, and recruiting for clinical trials.

Earlier this year, LunaDNA announced a partnership with the Genetic Alliance. By linking the participant and patient communities of the Genetic Alliance to LunaDNA’s research platform, individuals will have more resources to share their health data for medical research and to understand their options for clinical trials.

Industry-advocacy partnerships will continue to evolve, but it may not be from necessity, but from a shared mission.

“[They] say that finding people for clinical trials is like looking for a needle in the haystack,” Terry describes. “But basically, no, it’s not. The haystack is made out of needles.

“In this case, every single one of us is useful to a clinical trial somewhere. My goal and the goal of LunaDNA is to bring as many people as possible into the system, and then they’re ready for a clinical trial.”

Luna is bringing together individuals, communities, and researchers to better understand life. The more we come together to contribute health data for the greater good, the quicker and more efficient research will scale, and improve the quality of life for us all.  

Directly drive health discovery by joining the Tell Us About You study. 


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.


Pharmacogenomics and FDA Regulations

Here’s How Pharmacogenomics Is Changing Medicine For The Better


There are currently more than 40 drugs approved to treat depression. For many patients, it can be an experience in trial and error to determine what drug or combination works the best with the fewest side effects.

In an ideal situation, your genetic profile could inform your doctor the best drug, along with the best dose. The good news is that this scenario is a growing and exciting field of research called pharmacogenomics. 

Pharmacogenomics describes how your genetic make-up could affect your response to certain drugs. This relatively new field combines the study of pharmacology with genomics, allowing researchers and clinicians to understand how individual genetics can be used to determine the best treatment in regards to efficacy, safety and other factors. Pharmacogenomics has found uses in cardiology, psychiatry, and oncology, among other therapeutic areas.

There are nearly 400 drugs approved by the U.S. Food and Drug Administration (FDA) that use pharmacogenomics in prescribing. In addition, there are non-human genetic biomarkers, including those found in your microbiome, that can affect how your body reacts to drugs like antibiotics.

One example of using pharmacogenomics in treatment is the use of CYP2D6, an enzyme metabolized in the liver. There are over 100 variations of this enzyme, with many dependent on ethnicity, that can affect toxicity and efficacy. For example, drugs that treat high blood pressure and depression can be personalized dependent on CYP2D6 pharmacogenetics, such as the dose, response and toxicity risk. It can also affect the efficacy of the breast cancer drug tamoxifen and the body’s metabolizing of codeine to morphine.

Psychiatry is one field where pharmacogenomics is gaining increasing attention. The Clinical Pharmacogenetics Implementation Consortium recommends clinicians not prescribe certain drugs to patients who carry variations of CYP2D6 or CYP2C19 associated with rapid or slow metabolism of these drugs. However, few clinical guidelines exist on when and how to provide patients genetic testing to determine if they carry these variations. It’s estimated that at least 8% of patients would benefit from this type of testing. However, research is still ongoing, and the relationship between these genetic variations and the effectiveness of antidepressants has not been confirmed.

While this medical information is useful when clinicians are prescribing medicine for their patients, direct-to-consumer genetic testing companies are now providing pharmacogenomic results directly to individuals.

In late 2018, the FDA approved the first commercial pharmacogenomics test, however, it cautioned that the test is not intended to provide information on an individual’s response to a specific medication or be used to make treatment decisions. Almost immediately, the FDA issued a statement on direct-to-consumer genetic tests that provide pharmacogenomic results, essentially recommending against changing treatment decisions based on results from these types of genetic tests.

The FDA is now looking at regulating consumer companies in this field, especially as more and more companies provide pharmacogenomic results in their client reports. The federal agency is concerned that as this field grows, patients may receive inaccurate or incomplete results that lead them to make poor or even harmful treatment decisions. In April, the FDA issued a warning letter to one company it said was illegally marketing its pharmacogenomics test to the public

“We are particularly concerned about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established and are not described in the drug labeling and continue to warn patients and health care professionals that they should not rely on these tests for treatment decisions, ”said Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a recent press release from the FDA.

Similar to releasing genetic results without the nuances of a genetics counselor to help interpret the results, the agency is concerned patients will make treatment decisions based on tests that could be inaccurate.

However, several groups are questioning the FDA’s recent actions. 

Four mental health advocacy  groups recently sent a joint letter to the FDA citing that this recent decision could impede innovation and inflict harm on patients. Health care providers and patients, they say, should have all of the information, tools and resources to advocate for the best treatments for themselves. In addition, the American Clinical Laboratory Association issued a letter to the FDA, sharing that the recent restrictions could increase medical costs and impact care.

While the use of marketing pharmacogenomics is being debated, the obvious answer is the need for more confirmatory research where pharmacogenomics is being used in clinical decisions. That’s where LunaDNA can help. 

Individuals who securely and privately share their genetic results in the LunaDNA platform can contribute to research, which may include pharmacogenomic. Users can be rewarded for their participation in crowd-sourcing science, while helping to advance discoveries in this field.


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.


Electronic Health Record Integration

Give More and Get More With Your Electronic Health Records


Now, you can directly contribute to research and earn ownership shares when you upload your digital health records to LunaDNA™ beginning today!

LunaPBC™, the public benefit corporation behind LunaDNA, reached a milestone today announcing our partnership with Medfusion. The partnership enables LunaDNA members to access electronic health records (EHR) privately and securely on LunaDNA via Medfusion’s Patient Data Application Program Interfaces (APIs). 

The ability to connect personal health records – doctor visit reports, lab test results, and more – with the LunaDNA platform is a giant step towards accelerating health discovery. For the first time, meaningful longitudinal data paired with genetic and lifestyle data will be available for researchers to drive discovery. Since your health data changes over time, combining it with your medication information, your exercise habits, and your genetics, is amazingly powerful for understanding disease and wellness.

Not only does access to health record information help researchers uncover new diagnoses and treatments, it also helps you manage your own well-being. By reviewing your own records on a regular basis, you can have more informed conversations with doctors and caregivers to take control of your health. Take the first step by connecting to your physician’s portals.

Connect Your Electronic Health Records – It’s Easy! 

If you haven’t connected to your Patient Portals yet, all you need to do is contact your doctor’s office and ask how to connect to the portal. They should provide you with a link and login information. From there, it’s pretty simple to log in and access your account and health records.

When connecting your health records to LunaDNA, all you need is the name of your doctor or doctor’s office and your portal login information. We have partnered with a company with over 15 years of experience in the healthcare industry to create and manage these integrations. Your data is synced to the LunaDNA platform, encrypted, and structured to enable downstream research aligned to our consent and privacy policies.  It is also available for you download and review at any time. 

If you need help connecting your EHR to LunaDNA, you can always contact our support team at support@lunadna.com or visit our Twitter status page for updates. 

TAKE THE FIRST STEP—CONNECT YOUR PATIENT PORTALS TOday.


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.