23andMe CEO: We Are Now the 'Poster Child' for Patient Empowerment
Consumer Gene Tests Face Uncertain Future
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But regulators\u003ca href=\"http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm\"> feared that people would misinterpret this health data\u003c/a>, which had not been clinically validated, or take action based on a \"false positive\" result.\u003c/p>\n\u003cp>Obstacles aside, the company has continued to \u003ca href=\"http://www.foxbusiness.com/markets/2015/03/12/dna-testing-firm-23andme-hires-biotechnology-executive-in-bid-to-develop-its/\">grow its team with some high-profile\u003c/a> hires, ink partnerships with big\u003ca href=\"https://www.genomeweb.com/genetic-research/23andme-pfizer-partner-genetic-research-target-lupus\"> pharmaceutical companies like Pfizer\u003c/a> and expand its customer base to more than 850,000 people. All this, while it continues to work with the U.S. Food and Drug Administration (FDA) to bring its DNA test back to market.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The secret to the company's success? Its unstoppable chief executive, Anne Wojcicki, who has stayed true to the company's core mission: To improve access to the human genome.\u003c/p>\n\u003cp>I spoke with Wojcicki shortly after a meeting with her ever-expanding staff, and a week before a rare vacation to a remote corner of the world with her sister, Susan Wojcicki, another Silicon Valley power player who works as the CEO of \u003ca href=\"http://youtube.com\">YouTube\u003c/a>. Our interview has been condensed and edited for brevity.\u003c/p>\n\u003cp>\u003cstrong>23andMe has certainly had its critics over the years, as it's ambitious in scope. What prompted you to start the company in the first place?\u003c/strong>\u003c/p>\n\u003cp>As a young analyst on Wall Street, I invested in health care companies. I loved it, but I felt conflicted. I would go to parties filled with people in health care, and it was all about making money and having fun. I was also volunteering at hospitals in my spare time. I noticed this disconnect between the world that was making money on health care and those who are using it.\u003c/p>\n\u003cp>I still cringe at the U.S. health care system that is focused on optimizing revenues, versus improving access to care. I wanted to democratize access and I also knew that very little money was spent on prevention. 23andMe is focused on showing people their health risks. If I can do that, I think I'm doing a great service.\u003c/p>\n\u003cp>\u003cstrong>What are some of the most eye-opening discoveries you've made by using your own service?\u003c/strong>\u003c/p>\n\u003cp>I remember the first time my family took the test, because we found out that Sergey [Brin, cofounder of Google and Wojcicki's husband] was a carrier for the LRRK2 gene, making him a carrier for Parkinson's Disease. That was monumental. We also found out that I have a higher risk for breast cancer and I'm a carrier of an inherited disease called \u003ca href=\"http://ghr.nlm.nih.gov/condition/bloom-syndrome\">Bloom's Syndrome\u003c/a>. I am now more proactive about my diet.\u003c/p>\n\u003caside class=\"pullquote alignleft\">\"I still cringe at the U.S. health care system that is focused on optimizing revenues, versus improving access to care.\"\u003cbr>\n\u003ccite>Anne Wojcicki, 23andMe CEO\u003c/cite>\u003c/aside>\n\u003cp>Another cool thing is the first time you see that your children are actually our children. Obviously I know they're mine as I saw them being born. But when you can see it in a digital form, it's pretty awesome. It's one of those moments where you feel like you're part of this legacy.\u003c/p>\n\u003cp>[Editors' Note: Wojcicki is still legally married to Google cofounder Sergey Brin, but the pair are separated. Google invested \u003cspan class=\"st\">$3.9 million in 23andMe in 2007.\u003c/span>]\u003c/p>\n\u003cp>\u003cstrong>Were you surprised by the FDA's warning letter? Or did you expect to overcome some major hurdles with this company?\u003c/strong>\u003c/p>\n\u003cp>When I worked on Wall Street, we knew that stocks would go up and go down. Likewise, we have always anticipated that there would be ups and downs with an ambitious company like this, which is focused on helping people understand, access and benefit from the human genome. The FDA letter was obviously a big bump in the road for us, but our board and our investors understood from the beginning that it wasn't going to be easy.\u003c/p>\n\u003cp>\u003cstrong>You recently experienced a small victory, with the FDA approving your test for a rare genetic disease called Bloom Syndrome. How did you feel when you heard the news?\u003c/strong>\u003c/p>\n\u003cp>It was one of the first times in the company that we had a standing ovation. We felt a ton of pride. On a personal level, this has been a big lesson. There is a level of steps and patience that is required. I'm trying not to inhale the health revolution all at once.\u003c/p>\n\u003cp>I also felt fortunate to have Kathy Hibbs [\u003ca href=\"https://www.linkedin.com/pub/kathy-hibbs/40/679/a0a\">23andMe's chief legal and regulatory officer\u003c/a>] on board. We understood even back in 2010 that we would be regulated as a medical device. But there was a lot of miscommunication on our behalf. With Kathy, we have someone who has paved the way towards getting the product to market.\u003c/p>\n\u003cp>\u003cstrong>What's next in the pipeline for approval after Bloom Syndrome?\u003c/strong>\u003c/p>\n\u003cp>I'm playing the role of the obedient CEO and deferring to Kathy [Hibbs] on this. With the Bloom Syndrome approval, the FDA \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm\">down-classified \u003cspan class=\"st\">autosomal recessive disorder\u003c/span>s.\u003c/a> We're pretty excited about that. \u003ca href=\"http://www.nigms.nih.gov/Research/SpecificAreas/PGRN/Background/Pages/pgrn_faq.aspx\">We are also looking at pharmacogenetics [how individuals respond to drugs]\u003c/a>; the BRCA gene test for breast cancer and disease risks, including Alzheimer's Disease.\u003c/p>\n\u003cp>\u003cstrong>A recent Washington Post article \u003ca href=\"http://www.washingtonpost.com/national/health-science/23andme-co-founder-anne-wojcickis-washington-charm-offensive/2014/06/27/b465b086-f240-11e3-9ebc-2ee6f81ed217_story.html\">described you as being on the \"charm offensive\" in D.C.\u003c/a>, as you have been seen liaising with folks from the White House and other federal agencies. Why the shift in focus?\u003c/strong>\u003c/p>\n\u003cp>One of the benefits of the warning letter from the FDA is that it brought me to D.C. often for conversations with policymakers. We weren't in D.C. enough before.\u003c/p>\n\u003cp>23andMe is now seen in D.C. as a poster child for this \"consumer empowerment\" movement, as we've spoken out publicly on this topic. I've said many times that consumers with no background in medicine can understand complicated ideas. We're seeing this idea circulate on the Hill that it's the right time for the consumer to transition from subject to participant.\u003c/p>\n\u003cp>\u003cstrong>We've heard your name in association with the President's \"Precision Medicine\" initiative. How involved have you been?\u003c/strong>\u003c/p>\n\u003cp>We are not that involved, but I have been super impressed with the initiative so far. They called out the fact that there should be far more consumer engagement in health care. For example, why hasn't there been a single federally funded study where consumers get their genetic information? All this money is going into research, but participants aren't getting their data back.\u003c/p>\n\u003cp>I saw Eric Green [director of the \u003ca href=\"http://www.genome.gov/\">National Human Genome Research Institute\u003c/a>] last night. There is definitely a vision in the government to get a larger number of people engaged and leverage a lot of data. They have to put together a plan for the initiative soon. I feel lucky I'm not part of it. It's going to be a lot of work over the next three months.\u003c/p>\n\u003cp>\u003cstrong>You've been partnering up with big pharmaceutical vendors and other stakeholders. How can we be sure that you won't detract from the core mission, and end up like the money-guzzling entities you encountered on Wall Street? \u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignleft\">\"There's men, there's women and then there's assholes. I recommend trying to work with the men and the women.\"\u003cbr>\n\u003ccite>Anne Wojcicki, 23andMe CEO\u003c/cite>\u003c/aside>\n\u003cp>Pharma isn't all bad. It's a necessary component of the health care system. They are the ones who make the therapies. But I do want us to do things differently in making sure the consumer is part of the solution, and we also want to continue to do work on prevention. I'm also keeping an eye on different health care models in other parts of the world, which I feel morally better about.\u003c/p>\n\u003cp>\u003cstrong>\u003ca href=\"http://www.forbes.com/sites/matthewherper/2015/03/12/23andme-enters-the-drug-business-just-as-apple-changes-it/\">23andMe is getting into drug invention,\u003c/a> which seems very ambitious given the high costs of bringing a new pharmaceutical to market. How will you find the resources?\u003c/strong>\u003c/p>\n\u003cp>We're going to do it differently. I find it outright crazy that so few firms are researching who this drug will work for. We want to do the right thing even if it means cutting down our market size.\u003c/p>\n\u003cp>There are so many inefficiencies in drug development and we'll take a different approach in clinical trial recruitment. We have almost a million people and growing, and we'll recruit directly from our database. As for the money, it will be solvable if we get to that point. We'll raise the funds if we have good target ideas.\u003c/p>\n\u003cp>\u003cstrong>What's next for the future? How about sequencing the whole genome, given the \u003ca href=\"http://www.nature.com/news/technology-the-1-000-genome-1.14901\">recent claims that it can be done for $1000\u003c/a>?\u003c/strong>\u003c/p>\n\u003cp>We are definitely thinking about sequencing. It's high on our list of priorities and topics. We've always said we'll move into it when it finally gets to an even more consumer-friendly price point.\u003c/p>\n\u003cp>\u003cstrong>Finally, KQED's Future of You \u003ca href=\"http://ww2.kqed.org/futureofyou/2015/03/23/what-digital-health-lacks-female-ceos/\">published some findings\u003c/a> on the lack of gender diversity in health care. Any advice for would-be female founders?\u003c/strong>\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>There's men, there's women and then there's assholes. I recommend trying to work with the men and the women! On a more serious note though, there should be more women in the industry. Gender diversity leads to more innovation for the entire sector.\u003c/p>\n\n","blocks":[],"excerpt":"23andMe's secret weapon? Its mission-driven, straight-talking CEO Anne Wojcicki. She opens up with KQED about DNA, diversity and more.","status":"publish","parent":0,"modified":1477283137,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":38,"wordCount":1639},"headData":{"title":"23andMe CEO: We Are Now the 'Poster Child' for Patient Empowerment | KQED","description":"23andMe's secret weapon? Its mission-driven, straight-talking CEO Anne Wojcicki. She opens up with KQED about DNA, diversity and more.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"23andMe CEO: We Are Now the 'Poster Child' for Patient Empowerment","datePublished":"2015-04-10T15:56:06.000Z","dateModified":"2016-10-24T04:25:37.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"1394 http://ww2.kqed.org/futureofyou/?p=1394","disqusUrl":"https://ww2.kqed.org/futureofyou/2015/04/10/23andme-ceo-we-are-now-the-poster-child-for-patient-empowerment/","disqusTitle":"23andMe CEO: We Are Now the 'Poster Child' for Patient Empowerment","path":"/futureofyou/1394/23andme-ceo-we-are-now-the-poster-child-for-patient-empowerment","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>\u003cstrong>Update, 12:00 p.m. Oct 21: \u003c/strong>\u003ca href=\"http://ww2.kqed.org/futureofyou/2015/10/21/its-back-23andme-relaunches-its-consumer-gene-test/\">23andMe relaunched\u003c/a> its gene test with dozens of health reports, making it the first direct to consumer DNA test to gain approval from FDA.\u003c/p>\n\u003cp>\u003cstrong>Original story:\u003c/strong>\u003c/p>\n\u003cp>Many media pundits wrote off a genetic-testing start-up called \u003ca href=\"http://23andme.com\">23andMe\u003c/a> in November of 2013, when federal regulators ordered an immediate halt to sales of its flagship product.\u003c/p>\n\u003cp>In exchange for a swab of spit, Google-funded 23andMe provided people with direct access to over 200 health reports, detailing their risk of getting or carrying the gene mutation for a disease such as breast cancer or Parkinson's disease. But regulators\u003ca href=\"http://www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm\"> feared that people would misinterpret this health data\u003c/a>, which had not been clinically validated, or take action based on a \"false positive\" result.\u003c/p>\n\u003cp>Obstacles aside, the company has continued to \u003ca href=\"http://www.foxbusiness.com/markets/2015/03/12/dna-testing-firm-23andme-hires-biotechnology-executive-in-bid-to-develop-its/\">grow its team with some high-profile\u003c/a> hires, ink partnerships with big\u003ca href=\"https://www.genomeweb.com/genetic-research/23andme-pfizer-partner-genetic-research-target-lupus\"> pharmaceutical companies like Pfizer\u003c/a> and expand its customer base to more than 850,000 people. All this, while it continues to work with the U.S. Food and Drug Administration (FDA) to bring its DNA test back to market.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The secret to the company's success? Its unstoppable chief executive, Anne Wojcicki, who has stayed true to the company's core mission: To improve access to the human genome.\u003c/p>\n\u003cp>I spoke with Wojcicki shortly after a meeting with her ever-expanding staff, and a week before a rare vacation to a remote corner of the world with her sister, Susan Wojcicki, another Silicon Valley power player who works as the CEO of \u003ca href=\"http://youtube.com\">YouTube\u003c/a>. Our interview has been condensed and edited for brevity.\u003c/p>\n\u003cp>\u003cstrong>23andMe has certainly had its critics over the years, as it's ambitious in scope. What prompted you to start the company in the first place?\u003c/strong>\u003c/p>\n\u003cp>As a young analyst on Wall Street, I invested in health care companies. I loved it, but I felt conflicted. I would go to parties filled with people in health care, and it was all about making money and having fun. I was also volunteering at hospitals in my spare time. I noticed this disconnect between the world that was making money on health care and those who are using it.\u003c/p>\n\u003cp>I still cringe at the U.S. health care system that is focused on optimizing revenues, versus improving access to care. I wanted to democratize access and I also knew that very little money was spent on prevention. 23andMe is focused on showing people their health risks. If I can do that, I think I'm doing a great service.\u003c/p>\n\u003cp>\u003cstrong>What are some of the most eye-opening discoveries you've made by using your own service?\u003c/strong>\u003c/p>\n\u003cp>I remember the first time my family took the test, because we found out that Sergey [Brin, cofounder of Google and Wojcicki's husband] was a carrier for the LRRK2 gene, making him a carrier for Parkinson's Disease. That was monumental. We also found out that I have a higher risk for breast cancer and I'm a carrier of an inherited disease called \u003ca href=\"http://ghr.nlm.nih.gov/condition/bloom-syndrome\">Bloom's Syndrome\u003c/a>. I am now more proactive about my diet.\u003c/p>\n\u003caside class=\"pullquote alignleft\">\"I still cringe at the U.S. health care system that is focused on optimizing revenues, versus improving access to care.\"\u003cbr>\n\u003ccite>Anne Wojcicki, 23andMe CEO\u003c/cite>\u003c/aside>\n\u003cp>Another cool thing is the first time you see that your children are actually our children. Obviously I know they're mine as I saw them being born. But when you can see it in a digital form, it's pretty awesome. It's one of those moments where you feel like you're part of this legacy.\u003c/p>\n\u003cp>[Editors' Note: Wojcicki is still legally married to Google cofounder Sergey Brin, but the pair are separated. Google invested \u003cspan class=\"st\">$3.9 million in 23andMe in 2007.\u003c/span>]\u003c/p>\n\u003cp>\u003cstrong>Were you surprised by the FDA's warning letter? Or did you expect to overcome some major hurdles with this company?\u003c/strong>\u003c/p>\n\u003cp>When I worked on Wall Street, we knew that stocks would go up and go down. Likewise, we have always anticipated that there would be ups and downs with an ambitious company like this, which is focused on helping people understand, access and benefit from the human genome. The FDA letter was obviously a big bump in the road for us, but our board and our investors understood from the beginning that it wasn't going to be easy.\u003c/p>\n\u003cp>\u003cstrong>You recently experienced a small victory, with the FDA approving your test for a rare genetic disease called Bloom Syndrome. How did you feel when you heard the news?\u003c/strong>\u003c/p>\n\u003cp>It was one of the first times in the company that we had a standing ovation. We felt a ton of pride. On a personal level, this has been a big lesson. There is a level of steps and patience that is required. I'm trying not to inhale the health revolution all at once.\u003c/p>\n\u003cp>I also felt fortunate to have Kathy Hibbs [\u003ca href=\"https://www.linkedin.com/pub/kathy-hibbs/40/679/a0a\">23andMe's chief legal and regulatory officer\u003c/a>] on board. We understood even back in 2010 that we would be regulated as a medical device. But there was a lot of miscommunication on our behalf. With Kathy, we have someone who has paved the way towards getting the product to market.\u003c/p>\n\u003cp>\u003cstrong>What's next in the pipeline for approval after Bloom Syndrome?\u003c/strong>\u003c/p>\n\u003cp>I'm playing the role of the obedient CEO and deferring to Kathy [Hibbs] on this. With the Bloom Syndrome approval, the FDA \u003ca href=\"http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm\">down-classified \u003cspan class=\"st\">autosomal recessive disorder\u003c/span>s.\u003c/a> We're pretty excited about that. \u003ca href=\"http://www.nigms.nih.gov/Research/SpecificAreas/PGRN/Background/Pages/pgrn_faq.aspx\">We are also looking at pharmacogenetics [how individuals respond to drugs]\u003c/a>; the BRCA gene test for breast cancer and disease risks, including Alzheimer's Disease.\u003c/p>\n\u003cp>\u003cstrong>A recent Washington Post article \u003ca href=\"http://www.washingtonpost.com/national/health-science/23andme-co-founder-anne-wojcickis-washington-charm-offensive/2014/06/27/b465b086-f240-11e3-9ebc-2ee6f81ed217_story.html\">described you as being on the \"charm offensive\" in D.C.\u003c/a>, as you have been seen liaising with folks from the White House and other federal agencies. Why the shift in focus?\u003c/strong>\u003c/p>\n\u003cp>One of the benefits of the warning letter from the FDA is that it brought me to D.C. often for conversations with policymakers. We weren't in D.C. enough before.\u003c/p>\n\u003cp>23andMe is now seen in D.C. as a poster child for this \"consumer empowerment\" movement, as we've spoken out publicly on this topic. I've said many times that consumers with no background in medicine can understand complicated ideas. We're seeing this idea circulate on the Hill that it's the right time for the consumer to transition from subject to participant.\u003c/p>\n\u003cp>\u003cstrong>We've heard your name in association with the President's \"Precision Medicine\" initiative. How involved have you been?\u003c/strong>\u003c/p>\n\u003cp>We are not that involved, but I have been super impressed with the initiative so far. They called out the fact that there should be far more consumer engagement in health care. For example, why hasn't there been a single federally funded study where consumers get their genetic information? All this money is going into research, but participants aren't getting their data back.\u003c/p>\n\u003cp>I saw Eric Green [director of the \u003ca href=\"http://www.genome.gov/\">National Human Genome Research Institute\u003c/a>] last night. There is definitely a vision in the government to get a larger number of people engaged and leverage a lot of data. They have to put together a plan for the initiative soon. I feel lucky I'm not part of it. It's going to be a lot of work over the next three months.\u003c/p>\n\u003cp>\u003cstrong>You've been partnering up with big pharmaceutical vendors and other stakeholders. How can we be sure that you won't detract from the core mission, and end up like the money-guzzling entities you encountered on Wall Street? \u003c/strong>\u003c/p>\n\u003caside class=\"pullquote alignleft\">\"There's men, there's women and then there's assholes. I recommend trying to work with the men and the women.\"\u003cbr>\n\u003ccite>Anne Wojcicki, 23andMe CEO\u003c/cite>\u003c/aside>\n\u003cp>Pharma isn't all bad. It's a necessary component of the health care system. They are the ones who make the therapies. But I do want us to do things differently in making sure the consumer is part of the solution, and we also want to continue to do work on prevention. I'm also keeping an eye on different health care models in other parts of the world, which I feel morally better about.\u003c/p>\n\u003cp>\u003cstrong>\u003ca href=\"http://www.forbes.com/sites/matthewherper/2015/03/12/23andme-enters-the-drug-business-just-as-apple-changes-it/\">23andMe is getting into drug invention,\u003c/a> which seems very ambitious given the high costs of bringing a new pharmaceutical to market. How will you find the resources?\u003c/strong>\u003c/p>\n\u003cp>We're going to do it differently. I find it outright crazy that so few firms are researching who this drug will work for. We want to do the right thing even if it means cutting down our market size.\u003c/p>\n\u003cp>There are so many inefficiencies in drug development and we'll take a different approach in clinical trial recruitment. We have almost a million people and growing, and we'll recruit directly from our database. As for the money, it will be solvable if we get to that point. We'll raise the funds if we have good target ideas.\u003c/p>\n\u003cp>\u003cstrong>What's next for the future? How about sequencing the whole genome, given the \u003ca href=\"http://www.nature.com/news/technology-the-1-000-genome-1.14901\">recent claims that it can be done for $1000\u003c/a>?\u003c/strong>\u003c/p>\n\u003cp>We are definitely thinking about sequencing. It's high on our list of priorities and topics. We've always said we'll move into it when it finally gets to an even more consumer-friendly price point.\u003c/p>\n\u003cp>\u003cstrong>Finally, KQED's Future of You \u003ca href=\"http://ww2.kqed.org/futureofyou/2015/03/23/what-digital-health-lacks-female-ceos/\">published some findings\u003c/a> on the lack of gender diversity in health care. Any advice for would-be female founders?\u003c/strong>\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>There's men, there's women and then there's assholes. I recommend trying to work with the men and the women! On a more serious note though, there should be more women in the industry. Gender diversity leads to more innovation for the entire sector.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/1394/23andme-ceo-we-are-now-the-poster-child-for-patient-empowerment","authors":["3252"],"series":["futureofyou_135"],"categories":["futureofyou_1060","futureofyou_1064"],"tags":["futureofyou_15","futureofyou_36","futureofyou_17","futureofyou_138","futureofyou_120","futureofyou_61","futureofyou_171","futureofyou_80","futureofyou_170"],"featImg":"futureofyou_1396","label":"futureofyou_135"},"futureofyou_45":{"type":"posts","id":"futureofyou_45","meta":{"index":"posts_1591205157","site":"futureofyou","id":"45","score":null,"sort":[1399336204000]},"guestAuthors":[],"slug":"consumer-gene-tests-face-uncertain-future","title":"Consumer Gene Tests Face Uncertain Future","publishDate":1399336204,"format":"audio","headTitle":"Future of You | KQED Future of You | KQED Science","labelTerm":{"term":54,"site":"futureofyou"},"content":"\u003cp>http://www.kqed.org/.stream/anon/radio/science/2014/05/20140505science.mp3\u003c/p>\n\u003cp>Consumers who want to find out about their genetic health risks without going to the doctor and paying a hefty price may have to wait. For a while, personal genetic tests were becoming more affordable and informative. But the industry took a blow last year when the government cracked down on Mountain View company \u003ca href=\"https://www.23andme.com/\">23andMe\u003c/a>.\u003c/p>\n\u003cp>That was the last consumer gene testing company still offering health information after two years of federal efforts to regulate the industry. Unlike other companies, many of which folded or sold, 23andMe is working with regulators to come back to the consumer genetic health market.\u003c/p>\n\u003ch2>A Passion for Consumer Genetics\u003c/h2>\n\u003cp>On a recent Thursday evening at the \u003ca href=\"http://www.calacademy.org/\">California Academy of Sciences\u003c/a> in San Francisco, the star of the show was not the giant T-Rex skeleton in the lobby but a small-framed, energetic Silicon Valley entrepreneur speaking about personal genetics.\u003c/p>\n\u003caside class=\"pullquote alignleft\">'One of the main things people think about when they think of their genetic information, is that they want the health interpretation.'\u003c/aside>\n\u003cp>\"I want to ask this audience, how many people have ever had a genetic test?\" said \u003ca href=\"https://www.23andme.com/about/board/\">Anne Wojcicki\u003c/a>, CEO of 23andMe.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>Of about 150 people in the audience, some 30 people raised their hands.\u003c/p>\n\u003cp>\"So my goal is in the next ten years that every single one of you would raise your hand,\" Wojcicki said.\u003c/p>\n\u003cp>Wojcicki said since 2007, more than half a million customers have sent in a saliva sample and gotten information that included their risks for developing cardiac disease and breast cancer, as well genetic traits such as how fast they metabolize caffeine. But last November the FDA ordered 23andMe to stop sales of its $99 tests.\u003c/p>\n\u003ch2>FDA to 23andMe: Stop Selling Gene Tests\u003c/h2>\n\u003cp>\u003ca href=\"http://www.fda.gov/newsevents/testimony/ucm219925.htm\">The FDA said\u003c/a>, in a very public letter, that the company's test kit was a medical device that needed to be regulated and that 23andMe failed to prove it was interpreting health results accurately.\u003c/p>\n\u003cfigure id=\"attachment_129\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2014/09/Wojcicki.jpg\">\u003cimg class=\"size-full wp-image-129\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2014/09/Wojcicki.jpg\" alt=\"23andMe CEO Anne Wojcicki, speaking at the annual SXSW festival in Austin, Texas in March 2014. (Jenny Oh/KQED)\" width=\"640\" height=\"480\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2014/09/Wojcicki.jpg 640w, https://ww2.kqed.org/app/uploads/sites/13/2014/09/Wojcicki-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2014/09/Wojcicki-320x240.jpg 320w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">23andMe CEO Anne Wojcicki, speaking at the annual SXSW festival in Austin, Texas in March 2014. (Jenny Oh/KQED)\u003c/figcaption>\u003c/figure>\n\u003cp>Wojcicki said the ruling has hit her company hard. \"As a result, we have had to stop offering our healthcare service, and it's had a significant impact because it's one of the main things people think about when they think of their genetic information, is that they want the health interpretation.\"\u003c/p>\n\u003cp>So now, 23andMe is working with the FDA in an effort to once again be able to offer health information. Meanwhile, the company can still provide ancestry information, which is already a crowded field.\u003c/p>\n\u003cp>Hank Greely directs the \u003ca href=\"https://www.law.stanford.edu/organizations/programs-and-centers/center-for-law-and-the-biosciences\">Center for Law and the Biosciences\u003c/a> at Stanford. He said dwindling sales will impact the company’s efforts to build a sizable research database—and that's important to its business strategy.\u003c/p>\n\u003cp>\"For those customers who agree to it by signing a somewhat opaque consent form,\" Greely said, \"they can sell that information to pharma and bio, but without lots of new customers coming in that service becomes less attractive to pharma and biotech.\"\u003c/p>\n\u003cp>Some have criticized 23andme for considering selling anonymized data. But Wojcicki is unapologetic.\u003c/p>\n\u003cp>\"23andMe partners with those companies because those are the people who are making therapies,\" she said. \"And if we want to get better therapies for breast cancer, and you want to get better therapies for asthma and migraines and all kinds of the other conditions that impact our lives, we have to work with pharma companies.\"\u003c/p>\n\u003ch2>Big Data May Lead to Medical Breakthroughs\u003c/h2>\n\u003cp>And here's where consumer genetics isn't just about the consumer. All that genetic information, or big data, can be used to run studies in search of medical breakthroughs. That means any company that wants to stay at the forefront has to keep up with the changing science.\u003c/p>\n\u003caside class=\"pullquote aligncenter\">'We know that the world has been quite focused on getting the so-called thousand-dollar genome.'\u003c/aside>\n\u003cp>In your human genome you have an entire set of 23 human chromosomes, made up of, among other things, DNA building blocks called base pairs. The human genome is composed of 3 billion base pairs.\u003c/p>\n\u003cp>Right now consumer gene tests take tiny snips of less than a million base pairs to look at one person’s unique genetic blueprint. Each of these unique variations is called a snp (yep, pronounced “snip”), for \"single nucleotide polymorphism.\"\u003c/p>\n\u003ch2>The Future Lies in Sequencing the Whole Genome\u003c/h2>\n\u003cp>But a snp is just a fraction of the entire genome. Scientists say the key to the future of genetics lies in sequencing the whole genome.\u003c/p>\n\u003cp>\"We know that the world has been quite focused on getting the so-called thousand-dollar genome,\" said Vance Vanier, vice president of reproductive and genetic health at San Diego-based \u003ca href=\"http://www.illumina.com/\">Illumina\u003c/a>. The company has just unveiled a system it claims can sequence a human genome for $1,000. That’s a big drop from the nearly $3 billion dollar price tag to sequence the first genome in 2003.\u003c/p>\n\u003cp>\"I think the story of the next five years is to see that affordability spread more and more to broader segments of society and to clinical laboratories specifically,\" said Vanier, who was CEO of an early consumer gene testing company called Navigenics.\u003c/p>\n\u003cp>And while he believes genetic testing will continue to be done primarily through medical professionals, he said he still sees a place for consumer gene tests. After all, Vanier said, there was a time home pregnancy tests had to be done in a doctor’s office. Now people can even buy over-the-counter HIV tests.\u003c/p>\n\u003cp>\"I think the pattern you see,\" Vanier said, \"is as information gets better understood and as there are more social safeguards around it to protect from a misuse of it, then there is increasing comfort of how it can evolve into the consumer market.\"\u003c/p>\n\u003cp>[ad floatright]\u003c/p>\n\u003cp>And so the debate continues between those that believe accessing your DNA has become a basic right and those who believe gene tests are better left to a doctor.\u003cbr>\n\u003cem>\u003cbr>\nSince this story published, 23andMe officials confirm they \u003ca href=\"http://www.reuters.com/article/2014/05/06/23andme-genetictesting-idUSL2N0NS0Y820140506?feedType=RSS\">are considering selling their gene tests in markets outside the U.S.\u003c/a> after facing hurdles with the FDA.\u003c/em>\u003c/p>\n\n","blocks":[],"excerpt":"Personal genetics companies that offer health insights are working to satisfy federal regulators and keep up with changing science.","status":"publish","parent":0,"modified":1477283845,"stats":{"hasAudio":true,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":25,"wordCount":1044},"headData":{"title":"Consumer Gene Tests Face Uncertain Future | KQED","description":"Personal genetics companies that offer health insights are working to satisfy federal regulators and keep up with changing science.","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":"","schema":{"@context":"http://schema.org","@type":"Article","headline":"Consumer Gene Tests Face Uncertain Future","datePublished":"2014-05-06T00:30:04.000Z","dateModified":"2016-10-24T04:37:25.000Z","image":"https://cdn.kqed.org/wp-content/uploads/2020/02/KQED-OG-Image@1x.png"}},"disqusIdentifier":"45 http://ww2.kqed.org/futureofyou/?p=45","disqusUrl":"https://ww2.kqed.org/futureofyou/2014/05/05/consumer-gene-tests-face-uncertain-future/","disqusTitle":"Consumer Gene Tests Face Uncertain Future","WpOldSlug":"45","path":"/futureofyou/45/consumer-gene-tests-face-uncertain-future","audioUrl":"http://www.kqed.org/.stream/anon/radio/science/2014/05/20140505science.mp3","audioDuration":null,"audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"audioLink","attributes":{"named":{"src":"http://www.kqed.org/.stream/anon/radio/science/2014/05/20140505science.mp3"},"numeric":[]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Consumers who want to find out about their genetic health risks without going to the doctor and paying a hefty price may have to wait. For a while, personal genetic tests were becoming more affordable and informative. But the industry took a blow last year when the government cracked down on Mountain View company \u003ca href=\"https://www.23andme.com/\">23andMe\u003c/a>.\u003c/p>\n\u003cp>That was the last consumer gene testing company still offering health information after two years of federal efforts to regulate the industry. Unlike other companies, many of which folded or sold, 23andMe is working with regulators to come back to the consumer genetic health market.\u003c/p>\n\u003ch2>A Passion for Consumer Genetics\u003c/h2>\n\u003cp>On a recent Thursday evening at the \u003ca href=\"http://www.calacademy.org/\">California Academy of Sciences\u003c/a> in San Francisco, the star of the show was not the giant T-Rex skeleton in the lobby but a small-framed, energetic Silicon Valley entrepreneur speaking about personal genetics.\u003c/p>\n\u003caside class=\"pullquote alignleft\">'One of the main things people think about when they think of their genetic information, is that they want the health interpretation.'\u003c/aside>\n\u003cp>\"I want to ask this audience, how many people have ever had a genetic test?\" said \u003ca href=\"https://www.23andme.com/about/board/\">Anne Wojcicki\u003c/a>, CEO of 23andMe.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>Of about 150 people in the audience, some 30 people raised their hands.\u003c/p>\n\u003cp>\"So my goal is in the next ten years that every single one of you would raise your hand,\" Wojcicki said.\u003c/p>\n\u003cp>Wojcicki said since 2007, more than half a million customers have sent in a saliva sample and gotten information that included their risks for developing cardiac disease and breast cancer, as well genetic traits such as how fast they metabolize caffeine. But last November the FDA ordered 23andMe to stop sales of its $99 tests.\u003c/p>\n\u003ch2>FDA to 23andMe: Stop Selling Gene Tests\u003c/h2>\n\u003cp>\u003ca href=\"http://www.fda.gov/newsevents/testimony/ucm219925.htm\">The FDA said\u003c/a>, in a very public letter, that the company's test kit was a medical device that needed to be regulated and that 23andMe failed to prove it was interpreting health results accurately.\u003c/p>\n\u003cfigure id=\"attachment_129\" class=\"wp-caption aligncenter\" style=\"max-width: 640px\">\u003ca href=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2014/09/Wojcicki.jpg\">\u003cimg class=\"size-full wp-image-129\" src=\"http://ww2.kqed.org/futureofyou/wp-content/uploads/sites/13/2014/09/Wojcicki.jpg\" alt=\"23andMe CEO Anne Wojcicki, speaking at the annual SXSW festival in Austin, Texas in March 2014. (Jenny Oh/KQED)\" width=\"640\" height=\"480\" srcset=\"https://ww2.kqed.org/app/uploads/sites/13/2014/09/Wojcicki.jpg 640w, https://ww2.kqed.org/app/uploads/sites/13/2014/09/Wojcicki-400x300.jpg 400w, https://ww2.kqed.org/app/uploads/sites/13/2014/09/Wojcicki-320x240.jpg 320w\" sizes=\"(max-width: 640px) 100vw, 640px\">\u003c/a>\u003cfigcaption class=\"wp-caption-text\">23andMe CEO Anne Wojcicki, speaking at the annual SXSW festival in Austin, Texas in March 2014. (Jenny Oh/KQED)\u003c/figcaption>\u003c/figure>\n\u003cp>Wojcicki said the ruling has hit her company hard. \"As a result, we have had to stop offering our healthcare service, and it's had a significant impact because it's one of the main things people think about when they think of their genetic information, is that they want the health interpretation.\"\u003c/p>\n\u003cp>So now, 23andMe is working with the FDA in an effort to once again be able to offer health information. Meanwhile, the company can still provide ancestry information, which is already a crowded field.\u003c/p>\n\u003cp>Hank Greely directs the \u003ca href=\"https://www.law.stanford.edu/organizations/programs-and-centers/center-for-law-and-the-biosciences\">Center for Law and the Biosciences\u003c/a> at Stanford. He said dwindling sales will impact the company’s efforts to build a sizable research database—and that's important to its business strategy.\u003c/p>\n\u003cp>\"For those customers who agree to it by signing a somewhat opaque consent form,\" Greely said, \"they can sell that information to pharma and bio, but without lots of new customers coming in that service becomes less attractive to pharma and biotech.\"\u003c/p>\n\u003cp>Some have criticized 23andme for considering selling anonymized data. But Wojcicki is unapologetic.\u003c/p>\n\u003cp>\"23andMe partners with those companies because those are the people who are making therapies,\" she said. \"And if we want to get better therapies for breast cancer, and you want to get better therapies for asthma and migraines and all kinds of the other conditions that impact our lives, we have to work with pharma companies.\"\u003c/p>\n\u003ch2>Big Data May Lead to Medical Breakthroughs\u003c/h2>\n\u003cp>And here's where consumer genetics isn't just about the consumer. All that genetic information, or big data, can be used to run studies in search of medical breakthroughs. That means any company that wants to stay at the forefront has to keep up with the changing science.\u003c/p>\n\u003caside class=\"pullquote aligncenter\">'We know that the world has been quite focused on getting the so-called thousand-dollar genome.'\u003c/aside>\n\u003cp>In your human genome you have an entire set of 23 human chromosomes, made up of, among other things, DNA building blocks called base pairs. The human genome is composed of 3 billion base pairs.\u003c/p>\n\u003cp>Right now consumer gene tests take tiny snips of less than a million base pairs to look at one person’s unique genetic blueprint. Each of these unique variations is called a snp (yep, pronounced “snip”), for \"single nucleotide polymorphism.\"\u003c/p>\n\u003ch2>The Future Lies in Sequencing the Whole Genome\u003c/h2>\n\u003cp>But a snp is just a fraction of the entire genome. Scientists say the key to the future of genetics lies in sequencing the whole genome.\u003c/p>\n\u003cp>\"We know that the world has been quite focused on getting the so-called thousand-dollar genome,\" said Vance Vanier, vice president of reproductive and genetic health at San Diego-based \u003ca href=\"http://www.illumina.com/\">Illumina\u003c/a>. The company has just unveiled a system it claims can sequence a human genome for $1,000. That’s a big drop from the nearly $3 billion dollar price tag to sequence the first genome in 2003.\u003c/p>\n\u003cp>\"I think the story of the next five years is to see that affordability spread more and more to broader segments of society and to clinical laboratories specifically,\" said Vanier, who was CEO of an early consumer gene testing company called Navigenics.\u003c/p>\n\u003cp>And while he believes genetic testing will continue to be done primarily through medical professionals, he said he still sees a place for consumer gene tests. After all, Vanier said, there was a time home pregnancy tests had to be done in a doctor’s office. Now people can even buy over-the-counter HIV tests.\u003c/p>\n\u003cp>\"I think the pattern you see,\" Vanier said, \"is as information gets better understood and as there are more social safeguards around it to protect from a misuse of it, then there is increasing comfort of how it can evolve into the consumer market.\"\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"floatright"},"numeric":["floatright"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>And so the debate continues between those that believe accessing your DNA has become a basic right and those who believe gene tests are better left to a doctor.\u003cbr>\n\u003cem>\u003cbr>\nSince this story published, 23andMe officials confirm they \u003ca href=\"http://www.reuters.com/article/2014/05/06/23andme-genetictesting-idUSL2N0NS0Y820140506?feedType=RSS\">are considering selling their gene tests in markets outside the U.S.\u003c/a> after facing hurdles with the FDA.\u003c/em>\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/futureofyou/45/consumer-gene-tests-face-uncertain-future","authors":["212"],"programs":["futureofyou_54"],"categories":["futureofyou_1060","futureofyou_1064"],"tags":["futureofyou_15","futureofyou_36","futureofyou_37","futureofyou_38","futureofyou_39","futureofyou_40","futureofyou_41","futureofyou_42","futureofyou_43","futureofyou_44"],"featImg":"futureofyou_51","label":"futureofyou_54"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. 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