Early in April 2017, the FDA approved a DNA test kit for home use. Developed by the genetic testing company, 23andMe, the kit reveals an individual’s genetic risk for developing 10 diseases including Parkinson’s, Alzheimer’s, celiac and a variety of blood diseases. It is the first kit of its kind to receive FDA approval for home use, although in 2015, the FDA approved a 23andMe home test kit for Bloom syndrome, a rare condition that increases cancer risk.
DNA – deoxyribonucleic acid – is the hereditary material contained in the cell nucleus and mitochondria of almost every living organism. It carries the instructions for building and maintaining the body’s functions, much in the way letters go together to form words.
Genetic testing examines an individual’s DNA to determine their genetic risk for developing specific diseases. It does this by identifying changes in the genes that cause the disease.
The approval means consumers now have direct access to DNA testing, but it is important to point out that while DNA testing can determine an individual’s genetic risk, it cannot confirm that the individual will get the disease. Along with genetic tendencies, lifestyle and environmental factors also play a role in disease development.
Although the kits are scheduled for release this month, some consider the FDA’s decision to be controversial due to past problems encountered by 23andMe. Prior to this month’s approval, in 2013, the FDA forced the 23andMe company to pull its over-the-counter genetic tests off the market amid concerns there was a lack of evidence the kits were accurate.
Now that 23andMe has received approval for the home genetic testing kit, it is predicted that additional DNA test kits will soon be approved as well.