F.D.A. Will Allow 23andMe to Sell Genetic Tests for Disease Risk to Consumers

      A company named 2andMe based in Mountain View, California has long sought the green light to sell consumers genetic tests. The Food and Drug Administration is allowing the company 23andMe to sell genetic test kits to consumers, this will allow them to test for the likelihood that they will inherit genetic diseases such  as Alzheimer's. Currently the companies test only include ten diseases including Parkinson , Celiac disease, Alzheimer's, Gaucher disease type 1, etc.  This landmark decision for the FDA is expected to allow more companies to release tests directly to the consumer. The health kit sold by 23andMe is retailed for $199.00 and is a simple process.

   

    After a customer purchases the kit they then spit into a tube and mail it o the 23andMe headquarters. The companies lab will extract DNA from the saliva and test it against genetic markers for certain diseases. The customer can then log into their account and see the report and its interpretation. Although i believe this is a big step in allowing the public to readily know if they are carrying a disease, i also find man drawbacks. Most who have a family history of illness may want to know right away if they too inherited the disease and with the new technology can know in a matter of days without properly preparing themselves mentally for the news. Once you have received the results there is no unknowing and that could lead to depression. Also the tests could confuse customers as the results do not indicate you have the disease but that you have a higher likelihood.

https://www.nytimes.com/2017/04/06/health/fda-genetic-tests-23andme.html?_r=0

https://techcrunch.com/2017/04/06/23andme-is-finally-allowed-to-tell-you-if-you-have-the-genes-for-parkinsons/

https://www.23andme.com

The Dark Cloud Around Genetic Testing

Thanks to advances in medical science over the years, doctors and patients are now able to rely on genetic tests to determine the occurrence of an array of medical issues. Genetic tests allow doctors to test the likelihood that an unborn child has a medical condition such as Down Syndrome or Edwards syndrome, or if a woman has a high risk for developing breast cancer. However, according to the New England Center for Investigative Reporting (NECIR), many of these genetic tests run a high percentage of false positives.

In the USA alone, there are over 13,000 genetic tests available. However, none of these genetic tests are required to prove to the FDA that the tests are accurate. For example, in a 2014 study by the New England Journal of Medicine, one prenatal genetic test on the market for Edwards syndrome, was found to be accurate only 40% of the time!

Inaccurate results can not only cause extreme emotional trauma, but can also lead to improper diagnoses and unnecessary treatments. In regards to prenatal testing, a patient who learns that their unborn child might have Edwards syndrome or Down syndrome may choose to end the pregnancy. According to a NECIR investigation, every false positive was found to, on average, cost the patient $775,278 worth of unnecessary treatment.

It is important to note that most of these genetic tests are done under the advisory of a genetic counselor, who is a trained medical professional that helps families select the right tests and decide on what to do with those test results. However, according to the NECIR, this is where another problem has recently begun to develop. Unlike with other healthcare professionals, companies are not required by federal law to report payments to genetic counselors. As a result, there is no real way of knowing if a particular genetic counselor has a conflict of interest with a certain test/company.

The way I see it, the FDA really needs to step in, and regulators must crack down on both genetic testing companies and genetic counselors. There should be mandatory guidelines and quality control tests that these genetic tests need to pass to be used, as well as including genetic counselors on the list of healthcare professionals that companies must report payments to. By doing the above, genetic tests will become more accurate, lead to more productive and true outcomes, and keep the evils of business out of the science. 

http://www.popsci.com/theres-no-guarantee-that-genetic-tests-are-accuratehttp://features.necir.org/genetic-counselors-independence