23andme is one such genomics company. Since such a kit is a medical device, it requires approval to be sold. The Food and Drug Administration was concerned because 23andme had not provided evidence that all of their reports were accurate. 23andme and similar companies can give people insight into health risks to watch out for, and are cheaper than the genetic tests that are administered by medical professionals. On the other hand, it is easy to misinterpret the results without a genetic counselor to explain them.

One thing the FDA expressed worries about is the BRCA gene. The BRCA gene contains tumor-fighting proteins. When this gene is mutated, women have a significantly higher chance of getting breast cancer. Someone with a mutant form of the gene will need to make an important decision. Some will have more frequent screenings, but others will have a double mastectomy to eliminate any chance of getting breast cancer. 23andme tests for the BRCA gene and the FDA questions the validity. If 23andme gives a false result, someone could have an unnecessary and invasive procedure.

On the other hand, the decision to have a double mastectomy would not be taken lightly, and every doctor would order additional testing before doing such a permanent procedure. In that case, the 23andme test only gives information about what would be wise to watch out for. Even if the result is false, no harm has been done.

My concern with 23andme isn’t the risk of people having procedures they don’t need, but the mental aftermath. 23andme gives percentages of the likelihood to get a disease. Someone who gets the test when they’re young might spend the next 50 years worrying about potential diseases. 23andme offers prevention tips, like eating a balanced diet and exercising regularly — are precautions that people should be doing anyway for general good health.

People also might misinterpret a genetic test if they get generally good results. Someone might think “Oh, it says I’m at low risk for a heart attack, I can eat whatever I want.” Although most diseases have a genetic component, environmental factors play a huge role as well. Whether or not someone will get a disease is not an absolute — it’s more like rolling a weighted die, and both genes and the environment contribute to the weight of the die.

Additionally, 23andme, or any other commercial genetic test, does not sequence the entire genome. There are plenty of genetic factors it does not take into account. We still know very little about how genes and the environment work in tandem, so people should not count on genetic testing to tell them every single health problem they might encounter.

There is no real health danger in allowing companies like 23andme to exist. People should be cautioned that genetic testing does not tell you everything and that some things shouldn’t be taken too seriously, but with the right mindset, genetic testing is a useful tool. The FDA shouldn’t be so hard on companies like 23andme. However, it would help if the paranoid consumers would stop giving the FDA a reason to worry.

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