At this time, we are unable to facilitate bulk ordering and distribution of our Personal Genetic Service by healthcare providers. Patients need to be afforded the opportunity to review our labeling before purchasing our Genetic Health Risk, Cancer Predispositions, Pharmacogenetics, and Carrier Status reports* available here: www.23andme.com/fda-info/.
If your patients are interested in participating in our service, they can purchase a kit at www.23andme.com.
We also ask that you keep in mind that it is a violation of our Terms of Service (Section 15) for any third party, including a medical professional, to resell or redistribute 23andMe kits. You can find our Terms of Service here: www.23andme.com/about/tos/.
Yes. Anyone may return the packaged kit to the laboratory using the prepaid shipping materials. However, your patients must personally register their kits online prior to returning them to our lab to ensure that their samples are linked to their accounts and that each patient has direct access to their 23andMe experience.
No. Each of your patients must individually create an account using their email address and register their kit under that account. Once your patient’s reports are ready, s/he can print and share the reports with you.
During the registration process, there are a number of consent documents that each member must review, including, but not limited to, our Terms of Service, Research Consent and Biobanking Consent. Our Terms of Service contemplate a contract with, and are binding upon, the end-user customer (i.e. the individual providing his/her DNA), so it is important the end-user customer registers the kit.
If you need to transfer ownership of a patient’s profile from your account to an account controlled by the patient, please contact our Healthcare Professional Support Team for assistance at firstname.lastname@example.org.
Our Healthcare Professional Community was created to help providers and their patients navigate genetics together in order to make important decisions about prevention, treatment and lifestyle choices. You can join to receive notifications about educational events and product updates and to get in touch with our clinical team.
We welcome all members of your healthcare team to join the conversation about personal genetics and how this evolving life science can be integrated into their practice.
The U.S. Food and Drug Administration (FDA) authorization includes additional reports and provides a pathway for similar reports meeting the same requirements for clinical and analytical validity. We do plan to add more reports, but we cannot comment on whether or when specific reports might be added. We also cannot comment on future pricing.
23andMe customers do have access to their raw genetic data, which they can view or download from their 23andMe account. This raw data has undergone a general quality review; however, only a subset of markers has been individually validated for accuracy. Thus this data is only suitable for research, educational and informational use. It is not for medical use.
We are currently authorized only to provide information about clinically relevant variants associated with higher risk for disease, and specifically for the e4 variant of the APOE gene associated with late-onset Alzheimer’s disease. Additional variants would need to meet the same requirements for clinical and analytical validity and may require additional regulatory processes, so we cannot speculate on whether or when this might happen.
At this time, 23andMe does not offer pre- and/or post-test genetic counseling services. Instead, we encourage customers, especially those who may be identified as high risk for a condition, to speak with their healthcare provider and/or meet with a genetic counselor to learn more. Links are provided throughout the report for the “Find a Genetic Counselor Tool” via the National Society of Genetic Counselors. This tool allows individuals to search for those genetic counselors who specialize in at-home or direct-to-consumer DNA testing, some of whom provide services via non-traditional methods such as telephone and video.
The reports included in the current 23andMe service represent diseases with associated genetic variants known to have a significant impact on risk and include conditions with significant customer interest, such as late-onset Alzheimer’s disease. 23andMe has received authorizations from U.S. FDA for several report categories, including carrier status, cancer risk and reports about drug processing.
In November 2013, the U.S. Food and Drug Administration (FDA) required that we cease marketing certain reports until we obtained FDA clearance. The FDA reviewed extensive analytical, clinical and scientific data from peer-reviewed literature that we submitted as well as our study data demonstrating user comprehension of our reports, which we described in this presentation. We can’t speculate on what the FDA will require for future clearances.
Many customers receive results approximately 3 to 4 weeks after the sample is received at the lab. However, processing times may vary and it may take up to 8 weeks to receive results.
23andMe is an exclusively online service. We do not mail, email or fax hard copies of reports. The information available to customers through the 23andMe Personal Genetic Service is presented online within their secure 23andMe account. When results are ready, a notification email will prompt individuals to log onto their accounts to view their reports.
Each patient’s reports are only available within their secure 23andMe online account. However, patients have the option to print each individual report to share with you. They may also be able to save certain reports as PDFs through their browser’s print function or access their account from either a mobile device or through our mobile app.
Although every patient is different, 23andMe has performed rigorous user comprehension studies and met all U.S. Food and Drug Administration (FDA) requirements for consumer comprehension.
User comprehension studies were performed to assess how well people understand Genetic Health Risk, Cancer Predispositions, Pharmacogenetics, and Carrier Status reports*. A diverse group of people answered questions about the test reports in a controlled, lab-based setting. Comprehension was tested through a two-step process. First, participants’ understanding of genetics was tested prior to viewing the educational module and test reports. Second, participants were shown the educational module and the test reports. Participants then completed the test report comprehension survey. Overall comprehension rates per test report concept were greater than 90% across all concepts.
We offer an extensive Help Center where customers can find information about their reports and tools as well as answers to any frequently asked questions. Customers can also contact our dedicated Customer Care Team here.
Although customers can view the full list of conditions included in their reports prior to purchase, they may be surprised by their results, particularly if they are inconsistent with their family history. Additionally, because genetic information is hereditary, the customer may learn something through their reports that pertains to a close relative. Because this family member may or may not want to know this information, relationships can be affected. Sometimes customers unexpectedly discover previously unknown biological relatives or known relatives do not appear as a biological relatives in their DNA Relatives list. More information on unexpected findings can be found here.
We will continue to work with the U.S. Food and Drug Administration (FDA) to seek additional authorizations for new reports. Given that our dialogue is ongoing, we are not able to speculate about what information may be available in the future.
Notifications are typically sent via email to inform our customers when relevant updates occur. Registered members of the 23andMe Healthcare Professional Community will also be notified of relevant changes to our service. You can register here.
We strive to provide meaningful Carrier Status reports for over 40 autosomal recessive conditions. Our Carrier Status reports are regulated by the U.S. Food and Drug Administration (FDA) and meet FDA requirements for being clinically and analytically valid. For detailed clinical and analytical performance information, please see our package insert. In addition, genetic variants must meet one of the following criteria to be included in a Carrier Status report.
Learn more by reading our whitepaper here.
All genetic markers in our reports are evaluated to ensure high data quality and accuracy. In order to ensure that the data we return to customers is highly accurate, we use a stringent algorithm to make genotype calls. Occasionally, a person’s data may not allow us to determine his or her genotype confidently at a particular marker due to random test error or other factors that interfere with the test. When the algorithm cannot make a confident genotype call, it gives a “Variants not determined” result instead.
In certain rare instances, a “not determined” result may appear if a person has two copies of a variant. This is because the majority of our Carrier Status reports* can only be used to determine carrier status in adults and do not determine if someone has two copies of the tested variants.
23andMe Genetic Health Risk reports identify whether a person has specific genetic variants associated with various health conditions and provide information about risk for these conditions. In some cases, a single copy of a variant is associated with increased risk; in other cases, two copies or a combination of variants may be necessary. Many of these conditions are also influenced by non-genetic factors and genetic variants not covered by our reports. Thus, having a variant or combination of variants associated with increased risk does not mean a person will definitely develop the disease or condition, and vice versa.
Our Genetic Health Risk reports are regulated by the U.S. Food and Drug Administration (FDA) and meet FDA requirements for being clinically and analytically valid. For these reports, see our package insert for detailed clinical and analytical performance information.
Genetic variants must meet one of the following criteria to be included in a Genetic Health Risk report:
When reporting quantitative measures of risk in these reports, preference is given to absolute risk over relative risk and to larger and more recent studies when available. Likelihood ratios may also be provided when data is available to derive these estimates. The populations to which risk estimates apply are always reported, as these risk estimates may not be accurate across populations.
Read our whitepaper here.
Some individuals seem very motivated by the information they discover, which can help to engage them and lead them into thinking about how health, genetics and lifestyle are all related. It is important, though, to emphasize that the 23andMe Health + Ancestry Service does not diagnose any diseases or conditions and that it does not include all possible genetic variants associated with a condition. However, we strongly believe the information obtained can still be useful when shared with an individual’s healthcare provider. Regarding the Genetic Health Risk reports*, knowing that your patient has a genetic risk factor can enable further discussion and identification of additional risk factors that may be present in that patient’s life, such as family history or certain lifestyle choices. The information provided in 23andMe reports is just one piece of a much larger disease risk puzzle because the conditions included in the Genetic Health Risk report category are caused by both genetic and non-genetic factors. Learning more about one’s genetic risk does not complete the disease risk picture. Instead, genetic risk information is another data point that, when followed up with appropriate diagnostic testing, and/or when taken in context with a patient’s other risk factors, may be able to help improve patient care and empower a patient.
Providing each and every one of our customers with accurate data is a top priority for 23andMe. All saliva samples are processed in labs that meet local regulations.
In addition, 23andMe is the first and only direct-to-consumer genetic service that provides Genetic Health Risk, Cancer Predispositions, Pharmacogenetics, and Carrier Status reports* that meet FDA requirements.
For more on our analytical validity, visit About Our Test.
23andMe’s webinar series provides education for healthcare professionals on topics related to genetics, the 23andMe experience and how to support patients with 23andMe results. 23andMe webinars are offered live and on demand to make it easier for busy healthcare professionals to access relevant information at their convenience.
View our list of previously recorded webinars and upcoming webinars to find programs that meet your educational needs.
At this time, we are unable to provide CME/CE/CEU credits for our webinars.
Yes, webinars will be posted to the Healthcare Professionals website for future viewing. As long as you register for a webinar, you will receive an email containing a link for viewing once the webinar has been posted to our website. Webinars are typically uploaded to the Resources tab of our website within a few weeks of original broadcast.
The portal was designed assist healthcare providers in understanding select pharmacogenetic test results using FDA label information and independent clinical guidelines published in peer-reviewed journals.
23andMe Pharmacogenetics reports* provide information about DNA variants that may influence the body’s ability to process certain medications. Having a variant means that some medications may be processed faster or slower than normal, which, depending on the medication, may reduce effectiveness or increase the chance of experiencing side effects. However, most medications won’t be affected by having these DNA variants.
23andMe Pharmacogenetics reports are intended to provide genetic information that may aid discussions between consumers and healthcare professionals about therapeutic options.
Currently, 23andMe provides three Pharmacogenetics reports to customers, along with two CYP2C19-related Medication Insight reports:
23andMe Pharmacogenetics reports have been authorized by the FDA and meet similar FDA standards of clinical and analytical validity as the 23andMe Carrier Status* and Genetic Health Risk* reports. All saliva samples are processed in CLIA-certified and CAP-accredited labs and are genotyped using a custom version of the Illumina Global Screening Array (GSA).
Accuracy was determined by comparing results from the 23andMe genotyping array with results from Sanger sequencing. Greater than 99% of test results were correct. While unlikely, the 23andMe Pharmacogenetics test may provide false positive or false negative results.
Answers to many of your questions may be found on our website. For additional information, please contact the 23andMe Healthcare Professional Support Team at email@example.com or our Medical Science Liaison at firstname.lastname@example.org.
Confirmed cases of genetic discrimination are rare. As of 2009, the Genetic Information Nondiscrimination Act (GINA) has provided Americans with protections against discrimination based on genetic information by employers and health insurers. GINA does not provide protections for life insurance or long-term disability insurance. Many states also have their own statutes prohibiting, or at least limiting, genetic discrimination. In California, for example, individual and group insurers are prohibited from requiring an individual to provide genetic information, using genetic information to decide eligibility or risk status or disclosing such information without consent.
Learn more about privacy and security at 23andMe on our Healthcare Professionals website.
We take our customers’ privacy very seriously. 23andMe customer data is protected by state-of-the-art physical, technical and administrative security measures.
Separate databases are used to keep the customers’ genetic information separate from their personal information, protecting their identity. External firewalls restrict unauthorized connections to our databases. All connections to our website are encrypted using SSL (Secure Sockets Layer) technology.
Our consumers are in control of their genetic information. In certain cases, they can authorize it to be shared with specific individuals, such as family members, healthcare professionals or institutions conducting disease research. We make every effort to ensure they maintain complete control.
We will not share any customer’s individual data without his/her explicit consent, and we do not provide information to law enforcement unless required to do so by a valid subpoena or court order.
* The 23andMe PGS test uses qualitative genotyping to detect clinically relevant variants in the genomic DNA of adults from saliva collected using an FDA-cleared collection device (Oragene·DX model OGD-500.001) for the purpose of reporting and interpreting genetic health risks and reporting carrier status. It is not intended to diagnose any disease. The relevance of each report varies based on ethnicity. Each Genetic Health Risk report describes if a person has variants associated with a higher risk of developing a disease, but does not describe a person’s overall risk of developing the disease. These reports are intended to provide genetic information that can be used to inform lifestyle decisions and conversations with healthcare professionals, but are not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication or how much of a medication you should take. Any diagnostic or treatment decisions should be based on testing or other information deemed appropriate by a healthcare professional. Our Carrier Status reports can be used to determine carrier status, but cannot determine if you have two copies of any genetic variant. These carrier reports are not intended to tell you anything about your risk for developing a disease in the future or anything about the health of your fetus, or your newborn child’s risk of developing a particular disease later in life. For Gaucher Disease Type 1, we provide a single report that includes information on both carrier status and genetic health risk. The Late-Onset Alzheimer’s Disease Genetic Health Risk report is indicated for reporting of the ε4 variant in the APOE gene and describes if a person has a variant associated with an increased risk of developing late-onset Alzheimer’s disease. The ε4 variant included in this report is found and has been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent. The Parkinson’s Disease Genetic Health Risk report (i) is indicated for reporting of the G2019S variant in the LRRK2 gene, and the N370S variant in the GBA gene, (ii) describes if a person has variants associated with an increased risk of developing Parkinson’s disease and (iii) is most relevant for people of European, Ashkenazi Jewish and North African Berber descent.
For important information and limitations regarding other genetic health risk reports and carrier status reports, visit https://www.23andme.com/test-info/.