Recently, the FDA moved to regulate the sale of home genetic testing kits. Such kits are planned on being sold to customers so that, in theory, they could better determine their genetic susceptibility to a variety of common medical diseases. Customers could then use this information to make more informed decisions about their health care. However, the FDA wrote that:
“it is important that they be analytically and clinically accurate so that individuals are not misled by incorrect test results or unsupported clinical interpretations.”
This actually makes a lot of sense as the companies who make these kits are motivated almost entirely by profit, rather than out of a desire to help people make better health decisions. Such as how fortune tellers have little ability to tell the future, but rather are telling their customers what they want to hear. Wouldn’t it be great if we could take a test to determine whether or not we would get Alzheimer’s disease or diabetes?
In fact, that are a variety of ways a person can tell if they are predisposed to getting diabetes or getting cancer, and you don’t need a DNA test to do them. Measuring your BMI and your waist circumference, and obtaining a blood pressure check and fasting glucose level, could help to determine if you might be at risk for developing diabetes or an obesity related illness. That doesn’t mean that genetic tests don’t, and won’t, have a place in modern medical practice.
Though normally, such genetic tests are interpreted and explained to patients by either a doctor or someone will special training in medical genetics. This is because the results of the tests are often ambiguous. Some genes discovered to predispose a person to a certain disease only increase risk by a small amount, and absence of the genes doesn’t mean that somebody is an OK to eat unhealthy food or get less exercise. Will genetic testing companies but as upfront about the limitations of their tests? That is a big concern that FDA has and is part of the reason why such genetic tests are now being regulated.
Often there is a complex interplay between a person’s genes, and their environment and lifestyle which determines their risk of developing a disease. For example, while there are a variety of genes which do predispose women to breast cancer, most cases of breast cancer are not inherited. In theory a woman who takes such a genetic test for breast cancer which comes up negative could be falsely reassured that she would not get breast cancer and she might delay seeking medical treatment for a suspicious lump or breast lesion.
But what about genetic tests made abroad and sold in the United States? There is already a thriving online pharmacy business which has somewhat circumvented laws in the United States. Genetic testing companies in other countries could send kits to consumers in the United States who would then send their DNA samples back to these companies to be analyzed. As more genes are discovered, and as DNA testing technology becomes less expensive, more of these companies may sprout up.
Some companies already offer genetic tests to determine where you’re ancestors came from. Savy consumers, who are making increased use of the internet to guide their medical treatment, may want to have their genetic susceptibility for certain diseases tested as well. Though how to interpret a genetic test and what to do next is something that is probably best left to professionals.
Nonetheless, a handful of such DNA testing services are being offered, and the FDA has not explicitly asked that they be discontinued. Though Walgreens have voluntarily dropped the sale of a DNA test kit it had been planning to offer. Likely, the FDA needs more time to study the implications of the DNA testing services and to see how customers use the service.
However, it is obvious that the results of such tests would be used to make medically related decisions, thus guaranteeing that the FDA will be watching this industry closely and will likely issue future guidelines.