23andMe’s COVID-19 study
The major goal of 23andMe’s COVID-19 study is to uncover genetic risks associated with severe outcomes of infections by SARS-CoV-2. Such associations may explain some variation in COVID-19 disease severity. In addition to providing direct-to-consumer genetic testing through the 23andMe® Service, 23andMe endeavors to advance biomedical science through genetic research.
What is the rationale for the 23andMe COVID-19 study?
Our primary objective is to investigate genetic links that could predispose individuals to severe COVID-19 symptoms. 23andMe’s large research database containing millions of genotyped individuals, combined with our ability to quickly survey our research participants, means that we are well placed to address questions related to the genetics of COVID-19 outcomes. If we are able to identify genetic links with COVID-19 outcomes, it may ultimately help researchers and scientists better understand the biology of the disease and why some experience more severe symptoms than others.
5/13/2020 Update: Study Expansion
We are now opening up the study to more individuals beyond just 23andMe customers, so that non-customers who have experienced severe symptoms of COVID-19 can contribute to research. Opening the study to those outside 23andMe will provide us with even more insights into COVID-19. For this latest arm of the study we are hoping to enroll an additional 10,000 participants, but depending on the interest we receive, we may consider opening it up to more individuals over time.
We’ve already enrolled more than 500,000 participants, 7,000 of whom have been diagnosed with COVID-19, into our study. Given that genetic studies often require large numbers of research participants, the more people involved in the study, the more likely we are to be able to identify genetic associations.
In order to participate in this latest arm of the research study, we are initially looking for individuals who have had COVID-19 and were hospitalized due to the disease. Understanding that these cases are extremely sensitive and many people are still undergoing the recovery process, we will not be directly targeting COVID-19 patients with recruiting materials. Rather, our hope is that once patients have recovered and are in a position to contribute, that they have the option to do so, if they choose.
Those participants who meet study eligibility requirements – determined through a detailed screening process – will receive a complimentary 23andMe Health + Ancestry kit. Like all 23andMe H+A customers, participants will have the option to receive and view 23andMe health reports. A full list of eligibility requirements is available at the 23andMe COVID-19 study public landing page.
We aim to publish results of the study for the benefit of the broader scientific community in the hopes the data can be used by other researchers to treat the disease. We are exploring potentially working with external researchers, but have not confirmed any collaborations as yet. We encourage any hospitals and healthcare systems who are interested in collaborating to reach out to us at email@example.com.
Who can I contact if I want to collaborate with 23andMe on the COVID-19 study?
23andMe is eager to hear your ideas about how our database can support your research on COVID-19 or SARS-CoV-2. If you are a researcher and have an idea for a collaboration project, please contact us at firstname.lastname@example.org.
What methods will be used by 23andMe during the study?
23andMe will be collecting data through baseline and longitudinal surveys targeted to both symptomatic and asymptomatic individuals. Using those data, our researchers will conduct a genome-wide association study (GWAS) to determine if any genetic variants are associated with severity of COVID-19 symptoms or disease susceptibility. Additionally, in order to elucidate possible non-genetic factors influencing variance in symptom severity, we will implement environment-wide association studies (ENWAS) at a regular cadence contrasting our baseline results on seasonal influenza with the current COVID-19 pandemic.
Why did 23andMe choose to administer longitudinal surveys vs. a one time survey?
A longitudinal approach enables us to collect data regarding new infections in the population should the outbreak continue to spread.
Does 23andMe have plans to assess the impact of the COVID-19 pandemic on mental health?
Assessing the impact of the COVID-19 pandemic on mental health is not the main goal of the study. However, we have been collecting longitudinal data for years through several surveys on anxiety, depression, recent emotions, and other factors influencing mental health that could be useful in future analyses relating to the COVID-19 study.
Will 23andMe investigate the role of non-genetic factors in COVID-19 susceptibility and severity of symptoms?
Yes. A body of evidence supports non-genetic factors in the etiology of pandemic influenza outcomes. Specifically, age, obesity, and neuromuscular disease have previously been identified as susceptibility markers, with odds ratios for mortality exceeding 2.5 for all three groups of outcomes. Other potential modifiers include pregnancy, prior exposure, frailty, and immune comorbidities. Given the observed effect sizes for non-genetic factors in pandemic influenza susceptibility, we would be remiss to exclude these variables from our examination of interindividual variation in susceptibility and severity of coronavirus infections.
To further our understanding of this pandemic and to contextualize the genome-wide association study (GWAS) results, we may also investigate non-genetic factors that play a role in COVID-19 severity, including but not limited to geography, demographics, and lifestyle.
How does 23andMe plan to differentiate between participants with influenza-like symptoms and COVID-19?
We will be asking participants if they have been diagnosed with COVID-19, confirmed by a test for SARS-CoV-2. However, we know that many individuals will not be tested for SARS-CoV-2, despite having symptoms. As such, there is a concern that we may have difficulty differentiating between individuals with flu-like symptoms and those with COVID-19. However, we may be able to identify this by shifts in the genetic associations over time; which is why our study design includes longitudinal surveys and repeated genome-wide association studies (GWAS). Additionally, 23andMe has influenza data collected over multiple years, which can serve as a baseline for comparison.
How many participants does 23andMe expect to have for this study?
Of those who have been diagnosed and those who are asymptomatic, we hope to obtain over 1 million total responses to the baseline survey. The number of people responding who have been diagnosed with COVID-19 will depend on the proliferation of the disease. It’s important to note that the best possible outcome is that the pandemic decelerates, which could leave us unable to identify people with COVID-19, and would limit our ability to identify genetic associations.
What are the inclusion criteria to participate in the study?
All study participants must be (1) existing 23andMe research participants, (2) living in the United States of America, and (3) over the age of 18.
Why is participation limited to individuals in the United States?
The majority of 23andMe research participants reside in the United States, where the study has been approved by an independent Institutional Review Board (IRB). There are no plans to pursue IRB approval to launch in other countries at this time, but this may be re-evaluated at a future date.
I think I fit the inclusion criteria for the study, and I am interested in participating. How can I join the study?
If you are eligible to participate in the 23andMe COVID-19 study, and have consented to participate in research with 23andMe, you can find the survey here. You must sign in to your account to access the survey.
How will 23andMe communicate the results of this study to the scientific community?
We are committed to publishing the results in open access journals. We will provide updates about the study and any associated publications on our @23andMeResearch Twitter account.
Will an Institutional Review Board (IRB) oversee the 23andMe COVID-19 study?
As with all our research, an independent institutional review board (IRB) will oversee the study. The IRB, E&I Review Services, has reviewed and approved the scope of the study, enrollment criteria, and the language used in the survey questions we will ask participants.
How will 23andMe protect the confidentiality of participants’ data collected during the COVID-19 study?
We have taken great care to design our service and research program with research participant’s privacy and data security in mind and we have a number of safeguards in place to ensure confidentiality. All data in the research computing environment are disconnected from contact and identifying information, and instead are coded with a unique research ID.
All 23andMe research is performed in a secure computing environment with access restricted to research scientists and system administrators. All 23andMe servers are protected by technical, physical, and administrative procedures. Additionally, our servers are monitored for unauthorized activity. Genetic data and sensitive account information such as passwords are encrypted, as are all data transfers between our servers and participants’ computers. For more information, please refer to our Privacy Statement.
How can I learn more about the study?
For more information, please check out our blog post.