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:
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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
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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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