More and more companies are selling genetic tests directly to consumers. You don’t need a prescription. Just go online and order a test and you’ll get a cotton swab with which you scrape the inside of your cheek.
You then send the cotton swab to a laboratory and await the answer: What do your genes have to say about your disease risks?
These tests may seem harmless. It’s only a bit of information. No one can be harmed by some information, it may seem.
But the information is sensitive and can have consequences. For example, the test can provide information about genetic predispositions that you can transfer to your children. Paternity can be determined. You can get information that you are at risk for a certain form of cancer or can suffer side effects from the drug that your doctor prescribed. In addition, information about risk of disease can cause you to begin to exhibit symptoms prematurely!
Are the tests reliable? How should the information be interpreted in your case? What should you do with it? – Can one really market such tests directly to consumers as any commercial product?
No, it looks like it soon will be impossible. The US Food and Drug Administration (FDA) recently informed a number of companies that sell genetic tests directly to consumers that the tests will from now on be treated as medical devices. Such devices must meet specific quality requirements and be approved product by product.
Also in Europe a change is underway, going even further. The European Parliament is proposing a regulation that would more or less ban selling genetic tests directly to consumers.
This EU proposal is described and discussed in an article in Science, written by Louiza Kalokairinou, Heidi Howard (from CRB) and Pascal Borry:
From having been regarded as harmless, the authors write, genetic tests are now proposed to be classified as medical devices on risk level C (on a scale from A to D). In addition, a medical prescription will be required to get a genetic test, and the test must be ordered by a physician. Genetic counseling must also be given.
Genetic tests are here to stay, but presumably in a different context than today. The proposed EU regulation requires a medical context for genetic testing, the authors write: a patient-doctor relationship.
The article ends asking: Will doctors’ waiting rooms soon to be filled by people who want prescriptions for genetic tests? Can doctors keep up with the rapid development of the field, which is required to interpret new genetic tests and assess how these can benefit individual users?
Whereupon I ask: If it is unclear if even doctors can manage the genetic tests, how could one have assumed that individual consumers could do it?