In the past, the analytical emphasis of DTC testing was on clinical and chemical testing. What research areas do these tests cover nowadays?
Genetic testing has become a new business model within DTC testing. The US company 23andMe, founded by Anne Wojcicki, the wife of Google founder Sergey Brin, does this on a grand scale. It offers comprehensive genetic tests to subsequently predict the risk for a whole number of diseases. This is problematic in two ways, because, on the one hand, it’s not measurable how these statements are actually scientifically substantiated. On the other hand, data protection is a big bone of contention, of course, especially because of the company’s close connection with Google. Thanks to this type of testing, information that is interesting for insurance companies, employers and life insurance companies, for instance, can be obtained and in turn be used against the consumer. These companies are generally not subject to doctor/patient confidentiality and don’t have to adhere to data protection laws as required by medical science. What’s also characteristic of these types of companies is that they take advantage of loopholes. Data is often stored in the cloud which is located somewhere abroad. If data is subsequently being abused, customers have no legal recourse since it is even unclear in which country a suit would need to be filed.
The business with DTC testing has already made its way into Germany. The Humatrix AG Company from Darmstadt has a similar business model. This company also takes advantage of a loophole to obtain the blood of its customers by having the patient go to a doctor after purchasing the test at a pharmacy, who then takes the blood sample and conducts genetic counseling. The problem here is that at that moment, the physician truly becomes the one that orders the test and bears the overall responsibility. That’s a clever trick: the company refers to the fact that the testing is done in accordance with the German Genetic Diagnostics Act (Gendiagnostikgesetz), GenDG. In reality however, physicians are actually unaware of the type of process they initiated by taking a blood sample and it is highly unlikely that a patient decides to forego the test when he or she has paid several hundreds of Euros for it a long time before being educated. The education itself then becomes a mere farce. Where do you see the risk of this type of diagnostics?
In medicine, laboratory tests need to attest a medical benefit before they can be used. However, this does not apply for testing outside of medicine! The test portfolio of 23andMe includes a fertility program. This testing can presumably not only determine the chances of future children having blonde hair but also whether they are at risk of developing colon or lung cancer in the future. Because of these inadmissible claims by 23andMe, the FDA initiated proceedings against the company and prohibited it from conducting these types of tests. The tests by 23andMe could also be ordered in Germany even though this is actually forbidden based on the German Genetic Diagnostics Act. Since these tests are used outside of the medical science realm, they are not subject to the necessary regulations such as quality controls and the required professional qualifications of the staff. Under the pretext of consumer protection and the guise of promoting free trade, very meaningful medical regulations are simply being circumvented! Referring to consumer protection is also misleading since the consumer is often not able to decide whether the product truly works and keeps its medical promises.