The 23andMe Personal Genome Service Genetic Health Risk tests may get to have potentially life-saving uses but it pays if consumers are aware about the potentials and limitations of the test.
For those planning to give the newly approved genetic testing kit a try, here are some of the things you need to know before sending in your saliva sample and spending $199.
Results Alone Won't Make A Difference
In an April 6 statement announcing the decision, the Food and Drug Administration said that the tests only assess the genetic risks for the conditions. The results alone won't be life-saving. Consumers still have to use the results they get to make lifestyle decisions or to consult with a health care professional.
The Test Does Not Give Disease Diagnosis
The test scans your DNA for genetic mutations that are linked to a specific disease. If it finds one, the mutation does not necessarily mean you will develop the illness. It simply tells you that you have an increased likelihood for that specific disease compared with someone without that genetic tweak.
The results would basically tell you if you have increased risk for a particular disease but these are not a diagnosis or a guaranteed predictor that you will develop a specific health condition.
Test To Assess Genetic Risks For 10 Diseases Or Conditions
The test will only provide genetic risk assessment for 10 diseases or conditions: Parkinson's disease, late-onset Alzheimer's disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia and other uncontrolled movements, factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis, and hereditary thrombophilia.
Relevance Of Results May Vary Depending On Your Descent Or Ethnic Group
Geneticists have conducted more studies of people of European descent so there are more genetic data on white people. Aware of this, 23andMe includes warnings in its reports to inform consumers that the results are more relevant for particular groups of people. The effects of mutations may also vary depending on which ethnic group a person belongs to. The effect of the ApoE4 variant, for instance, is weaker in African-Americans.
23andMe GHR Test May Give False Positives
The FDA said that among the risks associated with using the test are false positive findings, which occur when a person gets a result that incorrectly indicates that he or she has a particular genetic variant. False negatives can also happen if the result incorrectly indicates that he or she doesn't have a certain genetic variant. The agency said that this is among the reasons the results from the tests should not be considered as a diagnosis or basis for treatment.
"It is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won't ultimately develop a disease," said Dr. Jeffrey Shuren, director at the FDA's Center for Devices and Radiological Health.