Highlights

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.

Which DNA test kit is better? 23andME vs. Ancestry DNA

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.

What is a BRCA test?

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?"