Healthcare providers are used to the unexpected from patients showing up in the clinic: A scan ordered for liver symptoms might reveal a spot in the lungs. Irregular findings on a blood test during an annual physical exam might lead to follow-up tests for leukemia.&nbsp;



But what happens when a DNA test gives your patient a surprising result about family relationships? 



More surprises are being revealed with more people engaging in direct-to-consumer tests like 23andMe that share information about genetic relationships between customers. 



If you work with a patient who comes into the clinic with a surprise DNA family discovery, below are a few questions you should ask yourself to help your patient navigate this unexpected discovery. <code></code>



<h2 class="wp-block-heading" id="h-how-is-this-affecting-my-patient">How is this affecting my patient?</h2>



<figure class="wp-block-image alignright"><img loading="lazy" decoding="async" width="300" height="300" src="http://35.88.189.111/wp-content/uploads/2017/03/dna-300x300.png" alt="An illustration showing a double helix strand of DNA" class="wp-image-25152" srcset="https://blogcms.23andme.com/wp-content/uploads/2017/03/dna-300x300.png 300w, https://blogcms.23andme.com/wp-content/uploads/2017/03/dna-150x150.png 150w, https://blogcms.23andme.com/wp-content/uploads/2017/03/dna-271x271.png 271w, https://blogcms.23andme.com/wp-content/uploads/2017/03/dna-372x372.png 372w, https://blogcms.23andme.com/wp-content/uploads/2017/03/dna-574x574.png 574w, https://blogcms.23andme.com/wp-content/uploads/2017/03/dna.png 600w" sizes="auto, (max-width: 300px) 100vw, 300px" /></figure>



Surprise findings of family relationships uncovered by a <a href="https://www.23andme.com/">DNA test</a> can have an emotional impact, and the discovery could impact your patient’s health. 



Probably the most dramatic impact would be if a patient discovered through DNA testing that their parents are not their biological parents. To handle such a discovery, a healthcare provider can offer understanding and grief support. 



Beyond that potentially traumatic experience are other surprises that could impact a person’s sense of identity. For instance, a patient could learn that the ethnicity they have always identified with is different. Not everyone is quick to adjust to unexpected changes in the way they <a href="https://slate.com/technology/2020/07/dna-test-ancestry-results-identity.html">self-identify in the world</a>. 



However, perhaps most relevant for a healthcare provider is that discovering new genetic connections would change a patient’s reported family health history, a cornerstone for many medical records. A patient may be forced to disregard their family medical history and be unable to replace it immediately with an accurate report. For some people, it is a long road to identify a newfound biological parent, make contact with them, request family medical information, and receive answers. For some, that information might never come. 



A healthcare provider should consider the different aspects and impacts of a family discovery, let your patient know they are not alone in their experience, and begin looking into the options. Referring them to the <a href="https://you.23andme.com/public/unexpected-relationships">Navigating Unexpected Relationships</a> page on the 23andMe customer website, if they have not already found their way to it, can be a great start.



<figure class="wp-block-image aligncenter"><img loading="lazy" decoding="async" width="512" height="289" src="http://35.88.189.111/wp-content/uploads/2021/01/DNAR.png" alt="An example of how to opt into DNA Relatives that includes a warning." class="wp-image-28736" srcset="https://blogcms.23andme.com/wp-content/uploads/2021/01/DNAR.png 512w, https://blogcms.23andme.com/wp-content/uploads/2021/01/DNAR-300x169.png 300w" sizes="auto, (max-width: 512px) 100vw, 512px" /><figcaption class="wp-element-caption">23andMe asks customers whether they wish to connect to DNA relatives and reminds them that they may find unexpected results.</figcaption></figure>



<h6 class="wp-block-heading" id="h-diana-s-story-a-case-study-of-an-unexpected-dna-discovery">Diana’s story, a case study of an unexpected DNA Discovery:</h6>



As a proactive person about her health, Diana spoke with her physician about direct-to-consumer DNA testing. He said using 23andMe was a nice way for her to explore genetics.  Both were shocked when a match in her DNA Relatives results listed matches that revealed she had a different biological father. 



This discovery is known as an NPE (a “not parent expected” discovery) in genealogy. While this kind of thing is well known enough to warrant an acronym, neither Diana nor her doctor were sure what to do once the discovery was made. 



<h2 class="wp-block-heading" id="h-into-whose-domain-does-this-concern-fall">Into whose domain does this concern fall?</h2>



This discovery had a huge impact on Diana. She described how it changed not just her sense of identity but also certain relationships in her life. But are those impacts relevant to her doctor? 



The short answer is yes. The medical field has branched into specialties to address the specific needs of patients, whether their issues involve the workings of the heart or of the mind. If a patient is distressed by a family discovery, they may need support from someone in the mental health space.



If a patient comes to them after making a significant discovery from one of these tests, a doctor may have to be able to answer questions about the accuracy or meaning of a test finding.  A healthcare professional may need to refer their patient to someone in genetics and family relationships for follow-up testing. 



<h2 class="wp-block-heading" id="h-medical-questions">Medical Questions</h2>



If the questions raised by the test are medical in nature, think of three professionals: medical geneticists, genetic nurses, and certified genetic counselors. These specialists work in many different areas—cancer, prenatal and preconception, neurology, metabolism—and are your partners in helping patients navigate the unexpected findings from DNA tests.&nbsp;



For Diana, her surprising discovery even led her to change plans. She had to visit the place she had believed to be her ancestral homeland. She discovered online resources like the Watershed DNA online forum where members discuss online and over weekly video calls the aspects of surprise DNA discoveries that impact them. Here’s what Diana had to say about what she wishes her doctor had done during the testing process:



&#8220;I wish my doctor had executed the same proactive approach to my NPE discovery and mental health as he did for my physical health. It isn&#8217;t enough to warn your patient that they might discover some unsettling news but to be prepared on how to lead your patient if that trauma occurs. A simple handout with a list of resources would have been enough to get me started. Not only would it have pointed me in the direction of healing, but it would also have been tangible evidence that I wasn&#8217;t alone in this experience.&#8221;



<h2 class="wp-block-heading" id="h-preparation-for-the-unexpected-is-key">Preparation for the Unexpected is Key</h2>



Most people who undergo DNA testing and opt-in to view DNA relatives do not receive a surprise like Diana’s. Most customers <a href="https://www.23andme.com/stories/">learn more</a> about health information, make expected connections to family, or confirm what they know about their genetic ancestors. 



Most healthcare providers will find a different set of questions a patient hopes to answer when talking with them about their 23andMe results. Being prepared for any situation that arises from a DNA test is key to being ready when a patient reaches out to discuss 23andMe.



<figure class="wp-block-image alignright"><img loading="lazy" decoding="async" width="300" height="267" src="http://35.88.189.111/wp-content/uploads/2020/11/image001-300x267.jpg" alt="Brianne Kirkpatrick" class="wp-image-28650" srcset="https://blogcms.23andme.com/wp-content/uploads/2020/11/image001-300x267.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2020/11/image001-1024x911.jpg 1024w, https://blogcms.23andme.com/wp-content/uploads/2020/11/image001-768x683.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2020/11/image001-880x783.jpg 880w, https://blogcms.23andme.com/wp-content/uploads/2020/11/image001-1180x1050.jpg 1180w, https://blogcms.23andme.com/wp-content/uploads/2020/11/image001.jpg 1596w" sizes="auto, (max-width: 300px) 100vw, 300px" /><figcaption class="wp-element-caption">Brianne Kirkpatrick, MS, LCGC</figcaption></figure>



Brianne Kirkpatrick is a genetic counselor and DNA consultant. She previously wrote about <a href="https://blog.23andme.com/ancestry-reports/dna-testing-for-adoptees/">DNA testing and adult adoptees for the blog.</a> She founded Watershed DNA and the author of the book DNA Guide for Adoptees. An alumnus of Indiana University and Northwestern University, Brianne is a member of the National Society of Genetic Counselors, American Board of Genetic Counseling, American Counseling Association, and International Society of Genetic Genealogy. She lives in Crozet, Virginia, with her husband and their three children.



<hr class="wp-block-separator has-alpha-channel-opacity" />

A photo of a doctor showing a patient information on a digital tablet.

Brianne Kirkpatrick

Navigating Family DNA Surprises, A Guide for Healthcare Providers

By Joe Banks, 23andMe Tech Lead
Editor’s note: This post by 23andMe’s Joe Banks, first appeared on 23andMe’s engineering blog. We’re reprinting an excerpt of it here to highlight issues around online accessibility and ideas for improving it. You can see the full version <a href="https://medium.com/23andme-engineering/accessibility-and-me-812c362031d2">here</a>.
I have a disability. Two, actually.
I was diagnosed with Usher Syndrome Type 2A, a rare genetic disease characterized by hearing loss and progressive vision loss.
When I was 3, my parents discovered that I was born with moderate-severe hearing loss in both of my ears. I was fitted with a pair of hearing aids, devices that would allow me to finally understand and hear my family.&nbsp;
The vision loss has had more of a profound impact on my life. While I knew that I was going blind, it didn’t feel real to me until I was in my 20s. I started to bump into people more frequently, which was followed by a quick apology by me and a glaring stare by the one whose space I invaded. Driving became increasingly difficult. For the safety of others and myself, I stopped driving at age 25. A few years later, I would learn how to use a white cane.&nbsp;
My visual field has narrowed from 180 degrees of visual field to less than 10 degrees. At this point, I’m considered legally blind and someone who has low vision.
&nbsp;

 <figure class="wp-block-image size-large is-style-default"><img loading="lazy" decoding="async" width="921" height="1024" src="https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw-921x1024.png" alt="" class="wp-image-28733" srcset="https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw-921x1024.png 921w, https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw-270x300.png 270w, https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw-768x854.png 768w, https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw-791x880.png 791w, https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw-1061x1180.png 1061w, https://blogcms.23andme.com/wp-content/uploads/2021/01/1-H-8KJLI4jqzxEbpJPPBEw.png 1400w" sizes="auto, (max-width: 921px) 100vw, 921px" /></figure>
 
Today, I continue to do what I love: building websites — here at 23andMe I’m a tech lead writing the code that powers 23andMe’s website — and lifting heavy metal as well as enjoying the outdoors.&nbsp;
At work, I visually scan my computer screen with the vision I have left, increase the contrast and brightness of my screen, enlarge my mouse cursor, zoom in on smaller text, and use my keyboard as much as I comfortably can.
But even with these tools at my disposal, I run into issues that are difficult to overcome while browsing the web.&nbsp;
I’m sharing my experience both as someone with disabilities and as a tech lead at 23andMe, to highlight actions engineers, designers and others can take to fix the issues that exclude people with disabilities. The beauty of much of the technology today—like smartphones, computers, and the Web—is that they&#8217;re designed to be accessible to people with disabilities. Engineers, like me, who build on these platforms, have the responsibility to uphold this design, and not break it. Below are issues that I have personally experienced and steps engineers and web designers can take to fix these types of issues.

<h2>Accessibility issues that affect me</h2>
<h6>Low color contrast</h6>
I have enough functional vision to read text on a screen, but my sensitivity to contrast has diminished over time. I opt to increase the contrast and brightness on my computer screen, but that only can get me so far.
Low contrast text is a trendy design pattern, but it fails to consider how it affects people with low vision. Unfortunately, this practice is so popular that it ranks as the number one most common accessibility violation found in the <a href="https://webaim.org/projects/million/">WebAIM Million</a>, an accessibility audit of the one million most-visited home pages on the web.
I tend to skip over text that has low contrast because it’s too much of a strain to read it. I know that others like me with low vision, have the same issues. It’s common for me to leave a website or trash an email if the content is too difficult to read. A simple and subtle change in contrast to the design could open all that content to others who are visually impaired.&nbsp;
It’s simple to first check the contrast and then fix it if it falls below the threshold that is visible to the people with low vision. To measure contrast ratio, you can use <a href="https://webaim.org/resources/contrastchecker/">WebAIM’s contrast checker</a>, or something similar. Enter the text color and background color, and the checker will tell you if the contrast ratio passes.
While testing for color contrast is easy, changing a color palette that’s been tied to a brand, like 23andMe, can be difficult. However, that isn’t an excuse to avoid the problem. After all, continuing to use a color palette that’s discriminatory to people with low vision is not good for a brand.
At 23andMe, <a href="https://style.23andme.com/">our design system</a> provides a color palette that indicates what colors meet the <a href="https://www.w3.org/WAI/WCAG21/Understanding/contrast-minimum.html">minimum color contrast (AA) set by the Web Content Accessibility Guidelines (WCAG)</a>. This shared knowledge ensures that designers and developers are on the same page when it comes to accessible color usage.

 <figure class="wp-block-image size-large is-style-default"><img loading="lazy" decoding="async" width="512" height="338" src="https://blogcms.23andme.com/wp-content/uploads/2021/01/23andMe-Color-Palette.png" alt="" class="wp-image-28734" srcset="https://blogcms.23andme.com/wp-content/uploads/2021/01/23andMe-Color-Palette.png 512w, https://blogcms.23andme.com/wp-content/uploads/2021/01/23andMe-Color-Palette-300x198.png 300w" sizes="auto, (max-width: 512px) 100vw, 512px" /></figure>
 
<h6>Inability to zoom</h6>
Another issue that people with low vision experience is the inability to magnify the text to make it more readable. Fixing that is also pretty straightforward by ensuring that the site isn’t restricting or disabling the zoom function.&nbsp;
<h6>No captions</h6>
While my hearing aids help me hear, they don’t completely restore my hearing. I’ll still miss words when listening to speech and I tend to subconsciously lip read when I’m talking to someone. When watching a video, I don’t always have the benefit of lip reading, so that’s when captions come in handy for me.
At 23andMe, we host our videos on YouTube. One of the great features of the platform is automatic captioning. This provides a quick and easy way for video authors to include captions in their videos. However, the quality of captions can vary, so it’s best practice to validate the captions in the video settings and make any corrections where needed. This ensures that the correct information is being communicated.
<h6>CAPTCHAs</h6>
I personally hate CAPTCHAs. Although they’re intended to prevent spam by distinguishing a human from a bot, for people with visual impairments are just another hurdle to accessing content.&nbsp; As someone with low vision, there’s nothing more frustrating than filling out a form and reaching a CAPTCHA where I repeatedly fail at scanning low-res photos for obscure objects. And what’s the alternative? Making out words in an audio track with distracting background noise? That’s also really difficult for me to accomplish with my hearing impairment.
I’m not alone. <a href="https://webaim.org/projects/screenreadersurvey7/#problematic">WebAIM’s 2017 screen reader survey</a> respondents agree that CAPTCHAs are the number one most problematic issue they face on the web.
Determining if someone is a robot is a tough problem to solve and there isn&#8217;t a clear solution. Non-interactive solutions, like Google&#8217;s reCaptcha v3, are great for accessibility. However, since users are tracked, privacy rights need to be considered and handled appropriately. In addition, methods to handle ambiguous results need to also be accessible and effective at blocking bots. My hopes are that the solutions developed for CAPTCHA consider people with disabilities and don&#8217;t lock them out.
To learn more about the challenges with CAPTCHA and accessibility, check out W3C’s document on the <a href="https://www.w3.org/TR/turingtest/">Inaccessibility of CAPTCHA</a>.
<h6>Moving forward</h6>
My journey with Usher Syndrome is still unfolding and I’m learning along the way. While I’ve accepted that this is my reality, I have an uneasy feeling about the current state of the web and what that means for my future. I’d like to continue being independent on the web, but I will need the help of the tech community to build experiences that I can continue to access and enjoy as my vision loss progresses.
In February 2020, WebAIM reevaluated the state of web accessibility for the top one million visited websites. Unfortunately, things have gotten worse since last year. Ninety-eight percent of the top million failed the accessibility audit. The kicker is that the audit only covered 30 percent of accessibility bugs.
This is a big problem. We need to do better.&nbsp; If we’ve learned anything from this pandemic, it is that access to the web whether it is for work, online learning, entertainment, or even simple social interactions is crucial for everybody.
At 23andMe, we’ve acknowledged this and have put an enormous effort towards making our digital experiences accessible. We&#8217;ve been working on educating colleagues about accessibility through talks, workshops, demos, online resources, and tickets addressing accessibility issues. Our design system requires components to be accessible and documents proper usage and accessibility considerations. To help prevent regressions, engineers are trained and provided documentation on how to evaluate accessibility with an automated scan, a keyboard, and a screen reader. The work continues, but we&#8217;re happy with the progress that we have made for our users.
I’ll end this with a few tips on getting started with accessibility. The breadth of accessibility topics can be pretty overwhelming, but starting somewhere is better than avoiding the problem.
<h6>Find where you can help and get involved</h6>
Accessibility is not just a front-end engineering problem.&nbsp;
If you have a role in making digital experiences that people use, then you should be familiar with how your decisions impact people with disabilities. For examples on how each role can contribute to accessibility, check out <a href="https://accessibility-for-teams.com/">Accessibility for Teams</a> and <a href="https://developers.google.com/web/fundamentals/accessibility/a11y-for-teams">Accessibility for Teams by Google</a>.
<h6>Learn about accessibility and share the knowledge</h6>
I started understanding accessibility when I began manually evaluating interfaces with a keyboard and a screen reader. I saw how bad the UX could be when accessibility is overlooked and how some features were completely unusable… and it was everywhere.
This prompted me to go back and re-evaluate how I was building websites. I browsed through <a href="https://webaim.org/articles/">WebAIM’s articles</a> on accessibility, watched through <a href="https://www.udacity.com/course/web-accessibility--ud891">Google’s online accessibility course</a> and used the <a href="https://www.w3.org/WAI/WCAG21/quickref/">WCAG as a quick reference</a>.&nbsp;
The point is, when you find out how you play a role in accessibility (see previous section), start digging into the topics where you can make the most impact.&nbsp;
Then, share that knowledge with your colleagues. At 23andMe, we’ve organized workshops, demos, meetings, and a company-wide presentation on a11y. In addition, we’ve curated documentation on a11y and created an #accessibility Slack channel where people can ask questions.
I invite you to start learning about accessibility and making the web a more inclusive place. At 23andMe, our mission is to help people access, understand and benefit from the human genome. We’re doing our best to include everyone in this pursuit. If you’d like to help us, please send feedback to our customer care team.&nbsp;
<h6>About the Author</h6>
Joe Banks is a tech lead at 23andMe and helps write the code for www.23andMe.com. He loves learning about new tech and aspires to make the Web more inclusive.

23andMe Blog

23andMe Blog Team

Accessibility and Me

Like most offices in Silicon Valley, these days 23andMe’s headquarters is largely vacant as employees have adjusted to working from home during the pandemic. But that hasn’t stopped us all from admiring the innovative design that went into the construction of the 145,500-square-foot building and how it is now being managed.
It’s comforting to know we’re not the only ones who noticed, and this week we learned that the U.S. Green Building Council recognized 23andMe for designing and managing its offices with energy efficiency, waste reduction, and sustainability in mind.
<h6>Going Green</h6>
The council awarded 23andMe with a Leadership in Energy and Environmental Design (LEED) Platinum designation for its Sunnyvale office building. The designation is based on a green building rating. Through design, construction, and operations practices that improve environmental and human health, LEED-certified buildings are helping to make the world more sustainable.
&#8220;We strive to ensure our work environments are designed and operated to achieve high performance, improve human health and protect the environment,” said Jason Lester, 23andMe’s Director of Workplace Experience. “Obtaining LEED Platinum certification for our Sunnyvale location demonstrates our commitment to doing so.&#8221;
<a href="https://www.usgbc.org/help/what-leed">LEED</a> is a globally recognized green building rating system developed by the U.S. Green Building Council. Achieving LEED certification helps:
<ul>
<li aria-level="1">Save money in energy, water, maintenance, and waste</li>
<li aria-level="1">Improve health with cleaner air, access to daylight, and reduced pollution</li>
<li aria-level="1">Reduce energy and carbon emissions with water conservation, reduced waste, use green materials, and sustainable strategies</li>
</ul>
Buildings like 23andMe’s Sunnyvale office earn points across several categories for various green building strategies in order to achieve LEED Certification. There are four possible LEED rating levels that can be achieved:
<h6>LEED Platinum</h6>
23andMe achieved LEED Platinum Certification by implementing practical and measurable strategies and solutions in areas including sustainable site development, water savings, energy efficiency, materials selection, and indoor environmental quality.
23andMe has also gone above and beyond the majority of LEED Certified buildings by ensuring that paints and coatings, flooring, insulation, and other composite wood materials in the Sunnyvale building were installed to meet stringent emission testing standards.
<h6>Looking Ahead</h6>
Though COVID-19 guidelines are currently preventing the majority of Sunnyvale employees from returning to the office, members of our Workplace team have remained in the offices developing the most optimal environment for employees to eventually return to. This includes benefits like:
<ul>
<li aria-level="1">Over 20 percent energy savings including the use of onsite renewable energy generation</li>
<li aria-level="1">Over 40 percent reduction of indoor water use</li>
<li aria-level="1">Higher indoor air quality due to enhanced ventilation and low-emitting material selection.</li>
</ul>
In the coming months, the work to maintain these standards will continue in preparation for a time when employees will be able to come back to work safely.

23andMe Awarded LEED Platinum Status for HQ’s Environmental Design  

23andMe recently received two additional privacy certifications from third-party auditors, while successfully re-certifying an existing security certification.
ISO certifications are awarded after extensive audits by independent third-parties. An international standard-setting organization develops the standards for each certification. In line with this commitment, 23andMe asked independent third-party auditors, Schellman &amp; Company,  to test and assess 23andMe against the standards for security and privacy under the ISO 27001, ISO 27701, and ISO 27018 certification. 23andMe is the first direct-to-consumer <img loading="lazy" decoding="async" class="aligncenter wp-image-29797 size-full" src="http://35.88.189.111/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide.jpg" alt="An image of a lock a computer, DNA and a mobile phone representing security protections." width="1562" height="800" srcset="https://blogcms.23andme.com/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide.jpg 1562w, https://blogcms.23andme.com/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide-300x154.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide-768x393.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide-1024x524.jpg 1024w, https://blogcms.23andme.com/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide-880x451.jpg 880w, https://blogcms.23andme.com/wp-content/uploads/2022/06/Privacy-Feature-Image-Wide-1180x604.jpg 1180w" sizes="auto, (max-width: 1562px) 100vw, 1562px" />
<h6>Security Standards</h6>
23andMe’s first certification, which we first received in 2019, is <a href="https://www.schellman.com/certificate-directory">ISO 27001</a>. We started with that certification because it is one of the most widely recognized and internationally accepted information security standards. It identifies requirements and specifications for a comprehensive Information Security Management System (ISMS). This defines how an organization should manage and treat information more securely, including applicable security controls. 23andMe’s ISO 27001 certification was recently re-certified, an achievement built on all the great work that teams across the company did to support security and privacy since the beginning.
But we didn’t stop there. This year, 23andMe added two privacy-focused ISO certifications —ISO 27701 and ISO 27018 — to complement our ISO 27001 certification. What do these certifications mean?
<h6>Protecting Privacy Rights</h6>
The first, ISO 27701, is a new standard for protecting the privacy rights of individuals. It is an extension of the standards that are part of ISO 27001, and requires a Privacy Information Management System. Some of the key requirements of an ISO 27701 certification include privacy awareness training, privacy notices, supporting consumer privacy rights, and more.
The other certification, ISO 27018, establishes commonly accepted controls and guidelines to protect Personal Information in cloud computing environments. Some key requirements for ISO 27018 include encouraging accountability via breach notification procedures and having more stringent security requirements for cloud services providers.
Every year, a third-party auditor will validate that 23andMe can demonstrate on-going compliance with these ISO certificates. These certifications act as additional proof of our commitment to information security and privacy and providing the most trusted experience for our customers. Privacy and Security are in our DNA, and we have the certifications to prove it.
To learn more about our privacy and security practices, please take a look at our <a href="https://www.23andme.com/privacy/?nav2=true">Privacy Center</a>.

23andMe Receives Data Security and Privacy Certifications

New research published this month adds to a growing list of empirical evidence that people find value in health information gleaned from direct-to-consumer <a href="https://www.23andme.com/" target="_blank" rel="noopener">genetic testing</a>.
The 23andMe study, published in the journal Molecular Genetics &amp; Genomic Medicine, found that direct-to-consumer testing can lead people to engage in critical conversations with their healthcare providers. In some cases, the results from their reports lead people to make behavioral changes to help lower their disease risk.
&#8220;Most study participants reported that knowing their genetic risk was an advantage,&#8221; said co-lead author Sarah L. Elson, Ph.D., and a 23andMe senior research program manager and senior scientist. &#8220;Many of those who learned about their risk did what you would hope. They either talked to their doctor or made lifestyle changes to help lower their risk.&#8221; <img loading="lazy" decoding="async" src="https://blog-api.23andme.com/wp-content/uploads/2008/09/bloodclot-300x223.jpg" alt="Blood cells clotting" class="alignright size-medium wp-image-1400" width="300" height="223" srcset="https://blogcms.23andme.com/wp-content/uploads/2008/09/bloodclot-300x223.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2008/09/bloodclot.jpg 350w" sizes="auto, (max-width: 300px) 100vw, 300px" />
<h6>The Impact of Direct-to-Consumer Genetic Testing</h6>
There have been anecdotal stories from customers about how their results positively impacted their lives, but the study adds data from a large cohort of customers, Elson said.
The study looked at how more than 2,000 people reacted to 23andMe&#8217;s Hereditary Thrombophilia Genetic Health Risk report.* (At the time the name of the report was Inherited Thrombophilia (Factor V Leiden-and Prothrombin-Related.) The participants responded to questions in two different online surveys consisting of just over 100 questions. 
They were asked about their perceptions of venous thromboembolism (VTE) risk, whether they discussed their results with healthcare providers, what if any recommendations they received, what actions they took to manage risk, their emotional responses to receiving risk results, and their perceived value of the information. The report looks at the two most common genetic risk factors for hereditary thrombophilia, more generally known as venous thromboembolism (VTE). VTEs are characterized by either deep vein thrombosis, clots that typically form in the legs, or pulmonary embolisms when clots travel into the lungs. Both are very serious and can lead to long term problems, and in some cases, even death.
<h6>The Prevalence of  VTEs</h6>
In the United States alone, there are between 300,000–600,000 cases of VTEs each year. About a quarter of those with VTEs have one of the two variants tested by 23andMe. These two variants are the Factor V Leiden variant in the F5 gene and the Prothrombin G20210A variant in the F2 gene. This study looked at how people reacted to learning whether they had one of those variants, as reported by 23andMe.
A little more than half of those in this study had one of these 2 variants associated with a higher risk for VTE. Ninety percent of those with a high-risk variant had never been clinically tested for Factor V Leiden or the F2 gene variant. After testing, a majority of consumers in the study — 78 percent of those with one of the risk variants and 58 percent without one of the variants — said that it was advantageous to have the test&#8217;s information. Just under half used that information as the impetus for a discussion with their healthcare provider. 
A majority of participants in the study who learned they had a higher than average genetic risk, found personal utility in receiving that information. The study also found that about 30 percent of the research participants made positive behavioral changes to control their risk, such as exercising more, after learning about their risk. 
<h6>A Growing Body of Research </h6>
The research is the latest in what has been a series of peer-reviewed studies over the last decade, explicitly looking at the impact of direct-to-consumer genetic testing. The best known of these is the <a href="https://www.genomes2people.org/research/pgen/">Impact of Personal Genomics Study</a>, known as the PGen study. The study was led by scientists at the Broad Institute and Harvard Medical School. That study and others have tackled several central questions around direct-to-consumer testing. Among those questions are: Can people understand this information? How do they use their test results? Do they use this information to <a href="https://www.genomes2people.org/wp-content/uploads/2018/07/20170502_PGen_BMCMedicalGenomics_Nielsen_DietExerciseDTC.pdf">manage their health?</a> Does testing impact their level of knowledge or <a href="https://blog.23andme.com/23andme-research/few-worry-about-genetic-testing/">anxiety regarding genetic health risks? </a>
Previous 23andMe research has also tackled some of these questions. One <a href="https://peerj.com/articles/8/">study</a> looked at how consumers responded to reports that showed an increased genetic risk for breast cancer. That study found that people followed the recommendations in 23andMe&#8217;s BRCA1/BRCA2 (Selected Variants) Genetic Health Risk report,* and talked to their doctors. They also got confirmatory tests from their healthcare providers. And they talked to family members about their potential risk, thereby creating a cascade-like benefit. 
In this latest study, looking at how consumers respond to information in their Hereditary Thrombophilia Genetic Health Risk report, 23andMe’s report also helps people who are asymptomatic and, absent of family history, might not have known of their risk for a VTE without 23andMe&#8217;s test. While the report does not cover all the genetic variants associated with VTEs, it does include the two most common and best-understood variants.
As the researchers state in the new study: &#8220;Taken together, these results suggest that consumers may experience personal utility from receiving DTC genetic results for VTE risk that is distinct from the potential benefit in receiving clinically actionable information.&#8221;
<hr />
*The 23andMe PGS test uses qualitative genotyping to detect select clinically relevant variants in the genomic DNA of adults from saliva for the purpose of reporting and interpreting genetic health risks. It is not intended to diagnose any disease. Your ethnicity may affect the relevance of each report and how your genetic health risk results are interpreted. 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. The test is 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, how much of a medication you should take, or determine any treatment.  Warnings &amp; Limitations: The 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of the 185delAG and 5382insC variants in the BRCA1 gene and the 6174delT variant in the BRCA2 gene. The report describes if a woman is at increased risk of developing breast and ovarian cancer and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer. The three variants included in this report are most common in people of Ashkenazi Jewish descent and do not represent the majority of BRCA1/BRCA2 variants in the general population. This report does not include variants in other genes linked to hereditary cancers and the absence of variants included in this report does not rule out the presence of other genetic variants that may impact cancer risk. The PGS test is not a substitute for visits to a healthcare professional for recommended screenings or appropriate follow-up.  Results should be confirmed in a clinical setting before taking any medical action. For important information and limitations regarding other genetic health risk reports and carrier status reports, click <a href="https://www.23andme.com/test-info/">here</a>. 
&nbsp;

New Study on People’s Response to Information from Direct-to-Consumer Genetic Testing

Starting today, we are offering current 23andMe health service customers in the U.S. access to 23andMe+ Premium, a new annual membership. This membership provides customers with exclusive access to genetic reports, as well as new reports and features as they become available throughout the year. These additional benefits are on top of the initial set of genetic reports customers received when first purchasing their kit.
We’ve heard firsthand that customers want more ways to engage in their personal genetics journey. As science continually advances, we want to provide ongoing access to impactful new genetic health reports, and enhanced health and ancestry features. 
Priced at $29 / year, 23andMe+ Premium will offer existing customers instant access to 10+ exclusive reports and features, including:<img loading="lazy" decoding="async" class="alignright wp-image-28529 size-medium" src="http://35.88.189.111/wp-content/uploads/2020/09/Heart-Health-Intro-1-1-160x300.png" alt="" width="160" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2020/09/Heart-Health-Intro-1-1-160x300.png 160w, https://blogcms.23andme.com/wp-content/uploads/2020/09/Heart-Health-Intro-1-1-545x1024.png 545w, https://blogcms.23andme.com/wp-content/uploads/2020/09/Heart-Health-Intro-1-1-768x1444.png 768w, https://blogcms.23andme.com/wp-content/uploads/2020/09/Heart-Health-Intro-1-1-468x880.png 468w, https://blogcms.23andme.com/wp-content/uploads/2020/09/Heart-Health-Intro-1-1-628x1180.png 628w, https://blogcms.23andme.com/wp-content/uploads/2020/09/Heart-Health-Intro-1-1.png 982w" sizes="auto, (max-width: 160px) 100vw, 160px" />
<ul>
<li>Pharmacogenetics reports* — discover how your DNA may impact the way your body processes certain medications with three new Pharmacogenetics reports.
<ul>
<li>Includes a Medicine Cabinet feature — simply type in your medication’s name to see if it is included in your Pharmacogenetics reports.</li>
</ul>
</li>
<li>Heart Health reports — learn how genetics may influence your likelihood of developing certain heart-related conditions like high blood pressure and atrial fibrillation.</li>
<li>Migraine report (powered by 23andMe Research) — see if your genetics can increase your likelihood of experiencing migraine headaches and how to avoid certain triggers.</li>
<li>Obstructive Sleep Apnea report (powered by 23andMe Research) — learn if you have a greater chance of developing the condition based on your genetics and, if so, how you can take action.</li>
<li>Enhanced Ancestry features — advanced filtering of DNA relatives and access to up to 3,500 more DNA relatives.</li>
<li>Ongoing new reports and features — get even more personalized genetic reports and more actionable insights throughout the calendar year.<img loading="lazy" decoding="async" class="alignright wp-image-28527 size-medium" src="http://35.88.189.111/wp-content/uploads/2020/09/PGt-Home-231x300.png" alt="23andMe mobile pharmacogenomics" width="231" height="300" srcset="https://blogcms.23andme.com/wp-content/uploads/2020/09/PGt-Home-231x300.png 231w, https://blogcms.23andme.com/wp-content/uploads/2020/09/PGt-Home-790x1024.png 790w, https://blogcms.23andme.com/wp-content/uploads/2020/09/PGt-Home-768x996.png 768w, https://blogcms.23andme.com/wp-content/uploads/2020/09/PGt-Home-679x880.png 679w, https://blogcms.23andme.com/wp-content/uploads/2020/09/PGt-Home-910x1180.png 910w, https://blogcms.23andme.com/wp-content/uploads/2020/09/PGt-Home.png 1583w" sizes="auto, (max-width: 231px) 100vw, 231px" /></li>
</ul>
Existing Health + Ancestry Service customers on our v5 chip can join 23andMe+ Premium by visiting <a href="https://you.23andme.com/subscription/">https://you.23andme.com/subscription/</a>. In the coming months, new customers will be able to join 23andMe+ Premium when they purchase our health service. With more genetic reports, more health insights, and more features, we hope 23andMe+ Premium gives individuals the choice to help them discover even more about themselves. Health is in our DNA.
<hr />
*The 23andMe PGS test uses qualitative genotyping to detect 6 variants in 3 genes in the genomic DNA of adults from saliva for the purpose of reporting and interpreting information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic and does not describe the association between detected variants and any specific therapeutic. Results should be confirmed in a clinical setting with independent genetic testing before taking any medical action.  Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For a complete list of the 6 variants tested, visit <a href="https://permalinks.23andme.com/pdf/pgt_product_info_page_21jan2020.pdf">Pharmacogenetics Important Test Information</a>.

An illustration of a heart for heart health

23andMe+ Premium: An ongoing approach to your genetics

Last June, following the tragic deaths of George Floyd and so many others in the Black community, our CEO <a href="https://www.23andme.com/black-lives-matter">pledged to hold ourselves accountable</a> to make improvements to ensure our people, products, and practices are more diverse, equitable, and inclusive.
Today, we wanted to share some of the steps we’ve started to take.

 <figure class="wp-block-image size-large is-style-default"><img loading="lazy" decoding="async" width="1024" height="536" src="https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog-1024x536.png" alt="" class="wp-image-28515" srcset="https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog-1024x536.png 1024w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog-300x157.png 300w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog-768x402.png 768w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog-880x461.png 880w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog-1180x618.png 1180w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-Blog.png 1200w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>
 
<h2>Established clear Diversity, Equity &amp; Inclusion (DEI) focus areas</h2>
In order for us to have a clear understanding of the areas where we can best focus our efforts, we conducted an in-depth audit from 2019 through 2020, which included data and feedback from the following sources:
<ul>
<li>Discussions with current and former Black employees</li>
<li>Employee exit survey feedback</li>
<li>Reviewed hiring data, looking at ethnic and gender diversity</li>
<li>Company-wide employee engagement survey responses</li>
<li>Past and current workforce demographics</li>
<li>An audit conducted by <a href="https://mathison.io/">Mathison</a>, an organization focused on hiring diverse talent</li>
</ul>
Based on the findings of this audit, we were able to identify four key company focus areas:
<ol>
<li>Hiring: Attract and hire top, diverse talent.</li>
<li>Employee Experience: Cultivate an inclusive environment that authentically celebrates our shared genome and unique differences.</li>
<li>Product &amp; Research: Use our product to build and sustain DEI in every customer and community interaction.</li>
<li>Community Impact: Use our relationships to build diverse, equitable, and inclusive communities.</li>
</ol>
Our approach is to ensure DEI is the foundation of how 23andMe fundamentally operates—it’s not an afterthought or a separate side effort. We have set clear goals, codified each of these four focus areas in our annual company strategy, and will measure how well we’re making progress quarterly.

 <figure class="wp-block-image size-large is-style-default"><img loading="lazy" decoding="async" width="1024" height="546" src="https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company-1024x546.jpg" alt="" class="wp-image-28513" srcset="https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company-1024x546.jpg 1024w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company-300x160.jpg 300w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company-768x409.jpg 768w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company-880x469.jpg 880w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company-1180x629.jpg 1180w, https://blogcms.23andme.com/wp-content/uploads/2020/09/DEI-company.jpg 1600w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>
 
<h6>Additional efforts aimed at improving DEI</h6>
Although we’ve primarily been working on establishing clear company focus areas, we have made good progress in some workplace, research, product, and community efforts over the past three months. Specifically, the company:
<ul>
<li><a href="https://blog.23andme.com/articles/celebrating-pride-month-a-spotlight-on-sex-and-gender/">Hosted a company-wide Pride event</a> to celebrate our employees and to educate allies</li>
<li><a href="https://blog.23andme.com/articles/black-information-network/">Became a Founding Partner for iHeart Radio’s BIN: Black Information Network</a>, the first and only national and local news audio service dedicated to providing an objective, accurate, and trusted source of continual news coverage with a Black voice and perspective</li>
<li>Began to build a more diverse leadership team by welcoming <a href="https://blog.23andme.com/articles/l-okey-onyejekwe-jr">L. Okey Onyejekwe Jr., MD &amp; JD</a>, as 23andMe’s Vice President of Healthcare Operations &amp; Medical Affairs</li>
<li><a href="https://blog.23andme.com/articles/transatlantic-slave-trade-paper">Published research detailing one of the most comprehensive investigations of the transatlantic slave trade ever done</a>, based on genetic data from close to 50,000 people</li>
<li><a href="https://blog.23andme.com/articles/chronic-kidney-disease-report">Launched a new Genetic Health Risk report on APOL1-related chronic kidney disease</a>*, which has particular relevance for customers with African ancestry</li>
<li>Through our COVID-19 research study, we were able to <a href="https://blog.23andme.com/articles/impact-disparities-of-covid-19">identify racial and ethnic disparities in the impact of COVID-19</a></li>
<li>Joined <a href="https://www.surveymonkey.com/newsroom/tech-companies-join-push-for-diversity-inclusion/">SurveyMonkey’s new initiative</a> to audit and track the diversity, equity, and inclusion practices of our vendors and service providers</li>
<li>Implemented enhancements to our HR systems to better track more dimensions of diversity and reduce bias in the candidate application process</li>
</ul>
<h2>Engaging employees across the company</h2>
Since kicking off our concerted DEI efforts, 23andMe employees have truly come together to volunteer their time and energy to create a better workplace and improve our product and community efforts.
We now have 96 active employee resource group members devoted to DEI, 23andWe. And nearly 290 employees, roughly 51% of our workforce, have joined our company Slack channel #diversity, where we discuss and share interesting articles, videos, and resources.
We believe progress can only come if all employees are motivated and engaged to drive positive change.
<h2>Continuing down the DEI path</h2>
While we’ve just started on this journey, we are encouraged by the enthusiasm of our employees. Please stay tuned as we continue to share the latest updates and news of our commitment to improving diversity, equity, and inclusion across our company, product, and community.
*The 23andMe PGS test uses qualitative genotyping to detect select clinically relevant variants in the genomic DNA of adults from saliva to report and interpret genetic health risks. It is not intended to diagnose any disease. Your ethnicity may affect the relevance of each report and how your genetic health risk results are interpreted. 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. The test is 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, how much of a medication you should take, or determine any treatment. The Chronic Kidney Disease (APOL1-Related) genetic health risk report (i) is indicated for reporting the S342G and N388_Y389del variants in the APOL1 gene, which define the G1 and G2 haplotypes, respectively, and (ii) describes if a person has variants associated with an increased risk of developing chronic kidney disease. The variants included in this report are the most common and best studied in people of African descent.

23andMe’s Commitment to Diversity, Equity & Inclusion

How employee volunteerism led to 23andMe&#8217;s new Volunteer Time Off benefit
Each summer busses packed with exhilarated kids make their way through the windy roads of Fresno county and arrive at the gates of Wonder Valley Ranch. 
As the kids unload, a group of cheerful camp counselors welcomes them with a pleasant overload of smiles, e-hugs, and happy tears. This tradition kicks off their favorite week of the year: Champ Camp!
Run by the <a href="https://www.aarbf.org/">Alisa Ann Ruch Burn Foundation</a> (AARBF), Camp Champ is a week-long stay-away summer camp for child burn survivors, provided at no cost to the families of survivors. 
Campers spend their days playing with their friends, hitting the water slides, crushing the ropes courses, going horseback riding, making crafts, chanting songs, and giggling during evening campfires in a safe environment. They’ve been doing this every summer for 35 years and it requires many devoted volunteers to pull off a perfect week at camp.
“Volunteering at Champ Camp has been the single most rewarding experience of my life,” said Jamie Calnan, Paralegal at 23andMe. 
<div id="attachment_28447" style="width: 310px" class="wp-caption alignright"><img loading="lazy" decoding="async" aria-describedby="caption-attachment-28447" src="https://blog-api.23andme.com/wp-content/uploads/2020/08/Camp-Champ-1.jpg" alt="" class="wp-image-28447 size-medium" width="300" height="225" srcset="https://blogcms.23andme.com/wp-content/uploads/2020/08/Camp-Champ-1.jpg 640w, https://blogcms.23andme.com/wp-content/uploads/2020/08/Camp-Champ-1-300x225.jpg 300w" sizes="auto, (max-width: 300px) 100vw, 300px" />Jamie, third from the left, during the pre-COVID-19 camp days.</div>
<h6>Volunteer Benefit</h6>
Calnan has been volunteering each summer for several years, but this year was different for a number of reasons. It happened as 23andMe was going through an internal initiative to make the company a better place to work. And Calnan, taking her experience at Camp Champ, suggested a new kind of perk — offering employees paid time for volunteering. 
After the initial suggestion, Calnan compiled data on volunteer benefit programs, developed a proposal, presented to 23andMe executive staff, and then anxiously awaited feedback. Shortly after, the proposal was approved, a policy was drafted and the new benefit was shared company-wide. 23andMe’s Volunteer Time Off Policy became effective June 1, 2020, just in time for Champ Camp.
“It was great to see leadership hear my suggestion and support expanding our employee benefits with a policy that allows individuals to get more involved with charity organizations close to their hearts,” said Calnan.
<h6>Rewards of Volunteering</h6>
But volunteering at Champ Camp is no summer vacation. It involves a serious commitment that requires dedication, passion, and a fair amount of time. New counselors go through interviews and training sessions in spring and all counselors report to camp two days before campers arrive, staying through the end of the camp week. This requires volunteers to take between 9-11 days away from home and work each year to volunteer. 
But it’s worth it, says Calnan. 
“It’s a lot of hard work and responsibility but each year tops the previous year,” she said. “Working with children who come from such different cultures, families, and daily lives, who each have their own extremely unique journey is powerful.”
<h6>Summer Camp in the Time of COVID</h6>
Like many organizations, Champ Camp was faced with a very unique challenge due to COVID-19. There was a question about how AARBF could even have a summer camp for the kids. But with the help of Calnan and a group of resourceful volunteers, they were able to create and deliver the world’s first online burn survivor summer camp. One hundred and thirty-seven campers received a “camp in a box,” a special package filled with everything you’d expect from summer camp including snacks, arts and crafts, and plenty of water balloons. Campers participated in online calls, virtual campfires, various other activities, and most importantly, still spent a treasured week with their friends and favorite volunteer counselors on-screen. 
The success of this annual camp would not be possible without such an extraordinary group of volunteers who continue to make a monumental impact on the lives of the campers. 
“It feels great knowing that my employer not only supports my enthusiasm for volunteering with AARBF but now helps provide the extra time,” said Calnan. “Champ Camp Rocks!”
To learn more about the Alisa Ann Ruch Burn Foundation and Champ Camp, visit us online at:<a href="https://www.aarbf.org"> https://www.aarbf.org</a>, or follow us online on Facebook at <a href="https://www.facebook.com/AlisaAnnRuchBurnFoundation/">https://www.facebook.com/AlisaAnnRuchBurnFoundation/</a> or on Instagram at: <a href="https://www.instagram.com/aarbf/">https://www.instagram.com/aarbf/</a>. Donations are gladly being accepted this year to help AARBF keep up their phenomenal work. Donations can be made at <a href="https://www.aarbf.org/usapay/">https://www.aarbf.org/usapay/</a>.

Making Good of Your Time

This week, the U.S. Food and Drug Administration (FDA) granted 23andMe a 510(k) clearance for a <a href="https://www.23andme.com/test-info/pharmacogenetics/">pharmacogenetics report</a> on two medications, clopidogrel, prescribed for certain heart conditions, and citalopram, which is prescribed for depression.
<h6>CYP2C19</h6>
The decision this week modifies the labeling of the previously authorized <a href="https://www.23andme.com/topics/pharmacogenetics/cyp2c19/">CYP2C19 Drug Metabolism</a> report which was granted FDA authorization <a href="https://blog.23andme.com/news/23andme-granted-the-first-and-only-fda-authorization-for-direct-to-consumer-pharmacogenetics-reports/">in 2018</a>. The new 510(k) clearance for the pharmacogenetics report for CYP2C19 modifies the labeling to remove the need for confirmatory testing and allows 23andMe to report interpretive drug information for two medications.
“This impactful pharmacogenetics information can now be delivered without the need for confirmatory testing, a testament to the clinical validity of 23andMe results,” said Kathy Hibbs, 23andMe Chief Legal, and Regulatory Officer. “23andMe remains the only company with direct-to-consumer pharmacogenetic <a href="https://blog.23andme.com/articles/fda-clearance">reports cleared by the FDA</a>. Now that we have pioneered a regulatory path, we believe all companies marketing pharmacogenetic reports should go through the FDA review process to ensure the safety and effectiveness of their tests.”
<h6>Validation</h6>
The clearance follows what was a <a href="https://blog.23andme.com/articles/move-toward-fda-clearance">rigorous analytical validation process</a> necessary to meet FDA requirements. This process included method comparison studies with expanded sample collection activities in order to increase the likelihood of obtaining certain rare allele combinations. This further mitigated the risk of false-positive or false-negative results. Accuracy exceeded 99 percent agreement with Sanger sequencing, which is considered the clinical ‘gold standard’ for testing.
Besides analytical validity, both 23andMe and the FDA also want to ensure that consumers understand these reports and use them properly, which includes adhering to their current medications and consulting with their healthcare providers. Based on 23andMe&#8217;s previous consumer comprehension studies, over 95 percent of users understood that they should not use the report to make any changes to treatment without consulting their doctor.
In its clearance decision, the FDA found that:  &#8220;As presented, the modified pharmacogenetic report for CYP2C19, without the confirmatory testing requirement, is a safe and effective consumer product that can safely and effectively assist customers with certain CYP2C19 genotypes in understanding how their body may respond to certain medications and encourage informed conversations with their healthcare provider.&#8221;
<h6>Clopidogrel</h6>
The report looks at two commonly prescribed medications. <a href="https://blog.23andme.com/articles/the-debate-over-clopidogrel-continues">Clopidogrel</a> is used to prevent serious or life-threatening blood clots in people who have had a stroke, heart attack, or severe chest pain.<a id="f1" href="#a1">[1]</a> Citalopram is used to treat depression and is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).<a id="f2" href="#a2">[2]</a> Individuals with certain genetic variants in the CYP2C19 gene may metabolize these medications differently and experience reduced efficacy and/or increased chances of side effects from these medications.
People with certain genetic variants who are taking clopidogrel or citalopram have a higher risk of serious adverse events, such as life-threatening cardiac events.<a id="f3" href="#a3">[3]</a> <a id="f4" href="#a4">[4] </a> This clearance allows 23andMe to give consumers information to share with their doctors through accurate variant detection and clinically <a href="https://blog.23andme.com/articles/fda-clearance">validated pharmacogenomic associations</a>, consistent with the FDA-approved drug labels for both of these medications.
These new medication response reports may be particularly impactful because of how common CYP2C19 variants are. Looking at data from more than 2 million 23andMe customers from diverse ethnic backgrounds who consented to participate in research, 23andMe scientists recently found that more than half had at least one CYP2C19 variant that could alter how their bodies metabolize clopidogrel and citalopram. 
<code style="display: none;"> 
</code>
<hr />
<h6>Footnotes</h6>
<a id="f1" href="#a1">[1]</a> <a href="https://medlineplus.gov/druginfo/meds/a601040.html" target="_blank" rel="noopener noreferrer">https://medlineplus.gov/druginfo/meds/a601040.html</a> (MedlinePlus, National Institutes of Health resource on medication)
<a id="f2" href="#a2">[2]</a> <a href="https://medlineplus.gov/druginfo/meds/a699001.html" target="_blank" rel="noopener noreferrer">https://medlineplus.gov/druginfo/meds/a699001.html</a> (MedlinePlus, National Institutes of Health resource on medication)
<a id="f3" href="#a3">[3]</a> <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d010775-1160-4b2e-a928-563a02edd191">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0d010775-1160-4b2e-a928-563a02edd191</a> (DailyMed, National Library of Medicine, clopidogrel)
<a id="f4" href="#a4">[4]</a> <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cf7b6823-108b-ebff-8f41-91f8b8325e3a" target="_blank" rel="noopener noreferrer">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cf7b6823-108b-ebff-8f41-91f8b8325e3a</a> (DailyMed, National Library of Medicine, citalopram)

News — Page 9