Article by Shannon Wieloch
The availability of genetic testing has exploded. You hear about it on television, the radio and the internet. Family members are verifying age-old stories of their ancestry. Co-workers are talking about the genes that predispose them to weigh 12% less than average.
With everyone doing it, a consumer may think, “Well, why not? It’s so simple.” Before grabbing a DNA kit, here are a few things to consider.
“Intended for clinical/diagnostic use or not intended for clinical/diagnostic use?” In the world of genetic testing, that is the distinction that needs to be made.
Genetic tests that are intended for clinical/diagnostic use are ordered by a physician. The results are then used to direct a patient’s medical care.
Genetic tests that are not intended for clinical/diagnostic use can be purchased directly by anyone, depending on the state in which they live. These tests generally fall into two groups:
As the name of the latter implies, the results from genetic tests that are not intended for clinical/diagnostic use are not intended to direct a person’s medical care. If a risk is identified, a genetic test that is intended for clinical/diagnostic use may be warranted.
For the sake of this blog post, we will focus on genetic tests that are not intended for clinical/diagnostic use.
Many companies offer these tests as DNA analysis can be conducted on a mail-in saliva or cheek swab sample. No laboratory visit is required.
Some companies don’t require a health care provider to order the test. Examples include 23andMe, Ancestry and National Genographic. Other companies require a physician’s order and contract with clinicians to review and obtain these orders. Examples of such companies include Mayo Clinic GeneGuide and Color.
Consumers are often notified through email when their results are ready and can then view them by logging into the company’s portal. Depending on the company, a genetic professional, such as a genetic counselor or medical geneticist, may be available to answer questions about genetic test results.
Of note, due to the sensitive nature of some results, consumers may wish to “opt out” of receiving results for certain diseases. An example of this is Alzheimer’s disease, for which prevention and treatment options do not currently exist.
Though not intended for clinical use, these tests may still identify the risk for a disease in a healthy person and thus may suggest the need to follow up with a genetic test that is intended for clinical/diagnostic use. This is especially true if a test includes information about how you may respond to different medications. Never change or discontinue your dosage in response to such test results. Consult with your provider to determine whether any changes to your medication would be appropriate.
So what are the benefits and limitations of genetic tests that are not intended for clinical/diagnostic use?
8 important considerations about genetic tests that are not intended for clinical/diagnostic use
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Shannon Wieloch, MS, LCGC is a Mayo Clinic genetic counselor supporting the Center for Individualized Medicine.
Tags: #direct-to-consumer genetic testing, #disease risk, #drug-gene interactions, carrier screening, center for individualized medicine, data privacy, diagnostic tests, education, Genetic Testing, mayo clinic, Mayo Clinic GeneGuide, pharmacogenomics, Precision Medicine, Rare diseases, undiagnosed diseases