Highlights
·
23&ME to offer BRCA cancer screening
test as apart of its genetic testing program
·
Test only covers 3 out of 1000 known genetic
variations within BRCA1/2 genes
·
23&Me BRCA negative test does not definitively
rule out the possibility of being diagnosed with breast, ovarian or prostate
cancer
In a blog post on it’s website 23&Me CEO and co-founder Anne
Wojcicki announced that the company has received FDA approval for a direct
–to-consumer genetic test that covers 3 variants of the BRCA1/2 genes that have
been linked to cause breast, ovarian and prostate cancer.
On the one hand this news does point to the scientific
headway that the company is making regarding the accuracy and ethical standards
of their genetic testing program with this recent stamp of approval by the FDA.
After an initial misstep, it appears that the company is now
playing nice with the FDA. In 2013 the FDA had previously halted production of
a direct-to-consumer genetic test for 254 medical conditions being promoted by
the company. Since then, in 2015 the FDA green lit a test providing future
parents with information about the genes their future children might carry and
in 2017 the FDA allowed 23&Me to provide genetic testing for 10 genetic
diseases including Parkinson’s and late onset Alzheimer’s.
The BRCA gene has been one of the greatest scientific
discoveries in regards to predicting risk of cancer risk. Women who have
inherited the BRCA1/2 genetic mutation are at a >75% lifetime risk for either
breast or ovarian cancer. So it is understandable women would want to get ahead
of this disease through genetic testing. Prophylactic measures have saved
thousands of women’s lives by knowing their BRCA status early on. Men who test
positive for the BRCA genetic mutations are also at risk for breast and
prostate cancer.
Movie star Angelina Jolie, increased awareness about BRCA
genetic testing when she made her own results public over the fact that she had
a mastectomy and both her ovaries removed as a result of testing positive.
This new information regarding the 23andMe offering should
be taken with a grain of salt. There are over 1000 different genetic variations
within these cancer causing genes that have been linked to an increased risk of
breast and ovarian cancer. Unfortunately, the 23andMe test only covers 3 of
those 1000 gene mutations. Therefore, this information should not be used in
lieu of complete genetic testing. A negative test does not indicate a zero or
reduced risk for getting cancer. Furthermore if you have a family history of
cancer, it is best to consult with a physician about the need for getting
genetic testing.
We at Jason-X are also concerned that this test ignores
higher at risk populations with African Founder mutations that are not covered
by the genetic variants approved for this test, (e.g. Bahamian Women).
The BRCA report will be included as apart of the larger full
health and genetic test that 23andMe offers for $199.
For a look at what that test looks like CLICK HERE.
Overall this is great news for 23&Me as it highlights
the strides that the company is making to empower consumers with their own
genetic information, however this information should not be used as a
definitive answer to "will you get cancer?"
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| 23andME Health + Ancestry Service ($199) |
