23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post.pdf

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Unformatted text preview: 23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post 3/7/18, 4)23 PM The Washington Post Wonkblog 23andMe gets FDA approval to report breast cancer risk without a doctor By Carolyn Y. Johnson March 6 at 2:53 PM The direct-to-consumer genetic testing company, 23andMe, has received federal approval to inform people of breast cancer risk linked to three gene mutations — making it the first company allowed to test for cancer risk without a doctor's prescription in the United States. The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics. The company can report back the three mutations in the BRCA1 and BRCA2 genes that are the most common in the Ashkenazi Jewish population. Those mutations are not the most common BRCA mutations in the broader population. Donald St. Pierre, acting director of the office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, called the approval a step forward with “a lot of caveats” in a statement. “Most BRCA mutations that increase an individual’s risk are not detected by this test,” St. Pierre said. “The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.” …port-breast-cancer-risk-without-a-doctor/?utm_term=.5bd04299ea1d Page 1 of 6 23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post 3/7/18, 4)23 PM 23andMe previously included breast cancer risk in its genetic tests in the United States but stopped in 2013 after the FDA sent the company a warning letter stating the company was marketing their test without approval. Anne Wojcicki, the co-founder and chief executive of 23andMe said the company's experience selling the test before 2013 in the United States and in the United Kingdom and Canada had provided insight into how useful the information can be, particularly to customers who did not realize they had Ashkenazi Jewish heritage. “Since the FDA warning letter, it's been a high priority for me and the company to get this report back,” Wojcicki said. “I'm thrilled today.” Wojcicki said although the company has not yet announced specific cancer risk mutations that it will add in the future, the approval surmounts a major hurdle. Direct-to-consumer genetic tests have typically raised concern because of fears people may not understand the information and panic or might be falsely reassured. Any person who comes back with a negative for these three gene mutations, for example, could still carry other mutations in the BRCA genes that elevate their cancer risk. They could also face elevated breast cancer risk because of other gene variations or other factors. Robert C. Green, a medical geneticist at Brigham and Women's Hospital, said the FDA's decision was somewhat surprising but gratifying — and a step forward in democratizing genomic information. Green has studied how people handle information about genetic disease risks, and he said that although the information can be upsetting, it can empower people to take actions. “I don’t want to trivialize the potential for serious psychological burden that this risk information might provide; however, it is risk information that we know can lead to life saving interventions,” Green said. “So you have to balance that against the distress people might feel.” …port-breast-cancer-risk-without-a-doctor/?utm_term=.5bd04299ea1d Page 2 of 6 23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post 3/7/18, 4)23 PM Read More: Why you shouldn’t know too much about your own genes Prenatal tests can now reveal whether a mom-to-be has cancer Gene therapy for inherited blindness sets precedent: $850,000 price tag ! 6 Comments Carolyn Johnson is a reporter covering the business of health. She previously wrote about science at the Boston Globe. " Follow @carolynyjohnson Your profile is incomplete Before you can contribute to our community, please visit your Profile page in order to complete your profile. Read These Comments: Subscribe to our weekly newsletter dedicated to the best conversations and comments on The Washington Post. Sign me up Comments My profile The conversation here is moderated according to The Post's discussion guidelines. …port-breast-cancer-risk-without-a-doctor/?utm_term=.5bd04299ea1d Page 3 of 6 23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post 3/7/18, 4)23 PM Post's discussion guidelines. Please read the rules before joining the discussion. Looking for your comment history? Your recent comments are available under the My Profile tab directly above this message. Comments submitted to our previous system can be found here. Send feedback about the comments section here. All Comments (6) Viewing Options! ddhunt 7 hours ago Of the people who test negative a few will have mutations not detected by 23 and Me's test. Some of these people will think they are in the clear and won't worry about breast cancer until the day the lump or invasive cancer is found. In the course of their care their mutation will be discovered. They will try to sue 23 and Me, but due to the FDA approved disclaimer they either did not read nor understand it will be near impossible to win. They will die. Wojcicki will continue to profit and will not care. Like " Reply # Link $ Report % drantigmo 1 day ago (Edited) Oh you're all sooo happy right now, right? "OH they are going to help save me!" When 23& me starts reporting the mutations to your insurance company, to the federal government, to the cloning farms, I wonder what you'll say then. Idiots. You should be suing; not clapping. Like " Reply # Link $ Report % …port-breast-cancer-risk-without-a-doctor/?utm_term=.5bd04299ea1d Page 4 of 6 23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post 3/7/18, 4)23 PM Katy Cart 1 day ago A win for consumers rather than Big Pharma or Big Medicine under Trump is a Big Win indeed. I'm adopted and the information in 23&Me offered, for the very first time, a look at health risks most people get at a family reunion. Please keep this available to me and others like me. Like " 1 Reply # Link $ Report % panoramapanache 8 hours ago Well actually, it's a win for Big Pharma given that selling the DNA to B.P. is exactly how they make their money. In fact, most of the info from 23andMe is not the type of health info people get at a family reunion. For those who are adopted, full sequencing of the coding regions of the genome is a reasonable option, with proper pre- and posttest genetic counseling. Remember the 23andMe assay assesses only 3 of over 20,000 mutations in the BRCA1 and BRCa2 genes. If you don't have those mutations it tells you nothing about your breast/ovarian cancer risk. Like " Reply # Link $ Report % unidentifiedsource 1 day ago Just a few weeks ago, commercialized genetic testing was labeled "recreational science" because the results provided by companies like 23andMe varied greatly and were often not reproducible. Now they can play doctor.... I wonder who got paid off for that to happen? Like " 1 Reply # drantigmo Link $ Report % 1 day ago …port-breast-cancer-risk-without-a-doctor/?utm_term=.5bd04299ea1d Page 5 of 6 23andMe gets FDA approval to report breast cancer risk without a doctor - The Washington Post 3/7/18, 4)23 PM drantigmo 1 day ago And I wonder who will be next to gather your DNA info.... and I wonder who passes what law FORCING them to turn over your DNA info to....... Like " 1 Reply # Link $ Report % …port-breast-cancer-risk-without-a-doctor/?utm_term=.5bd04299ea1d Page 6 of 6 ...
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