Direct-to-consumer genetic testing companies could cause their own controversy. Many of these companies are expanding their services to offer more information about health, and the FDA may crack down on the kind of info that can be provided.
About Direct-to-Consumer (DTC) Genomic Tests
There are many interesting things our DNA can tell us. Scientists have developed several different ways of querying our DNA for information. For example, they can look at the arrangement of our DNA in chromosomes (a karyotype). They can look for patterns in tiny portions of our genome called short tandem repeats (STRs), which can reveal our paternity and our ancestry. They can test for specific changes within a gene, or perform more comprehensive DNA sequencing of particular genes to look for changes that may cause disease. They can also scan our entire genome for single base changes and try to estimate what effect, if any, these changes will have on our health.
DTC or consumer genomic tests typically involve analyzing hundreds of thousands to over a million single nucleotide polymorphisms (SNPs). Some of these SNPs are known to be associated with a disease, drug response, or other phenotype that consumers might want to know about.
23andMe, for example, provides consumers with information on 78 gene-trait associations. According to information posted on the company’s website, 23andMe analyzes only those associations that have been published in peer-reviewed scientific literature. They divide the associations into two categories: established research and preliminary research.
Established research associations are those that have been confirmed in at least two large studies or have gained widespread scientific acceptance in the scientific community. Preliminary research associations are those that still need to be confirmed by the scientific community and may not stand the rigors of scientific replication. The company relies on an editorial team, which includes three Ph.D. scientists with university affiliations, to make decisions about which gene-trait associations to include in its analysis.
DTC Cenomic Test Controversies
Unquestionably, there are advantages to allowing consumers to access genetic tests directly. For example, DTC testing helps raise awareness of genetics in general and the interaction between genes and environment in particular, and it challenges physicians to be better educated. However, real and potential harms do exist. For one, there is currently very little federal oversight of DTC genetic testing.
Although all U.S. laboratories that offer test results to the public are required to be certified and employ certain basic practices per the Clinical Laboratory Improvement Amendments of 1988 (CLIA), these regulations do not address the clinical validity of the tests that a lab offers. In other words, even if a lab is certified, there is no guarantee that the test results that the lab provides are relevant to existing or future diseases or conditions.
In response to the consequential mishandlings of digital consumer data by Silicon Valley tech giants, California legislators have unanimously adopted the California Consumer Privacy Act. The bill will increase online privacy standards by forcing tech companies to disclose the information they collect about users, allowing them to opt out of having their information shared with third parties.
Although genetic testing companies like 23andMe aren’t monitoring and marketing your online profile like Facebook and Google, they are collecting and selling your genetic profile. The new California law appears to exempt DTC genetic testers, but should it? Genetic information is perhaps an individual’s most intimate information, and the European Union’s recently enacted General Data Protection Regulation has chosen to recognize this. The European policy includes DNA in the basket of “personal data” it governs, whereas in the U.S. the flow of genetic information remains curtained from political oversight.
Privacy risks for consumers sharing their DNA with testing companies shouldn’t be underestimated. Here are several potential risks that consumers should be concerned about.
Law Enforcement May Want Your DNA
Requests from law enforcement and courts for your data are already happening and also can be done under subpoena. Remember the Golden State Killer case that was recently cracked after decades? It was cracked with the help of DNA from a genealogy company. Catching a murderer is a good thing, but the ability of law enforcement to target your DNA through these testing companies is a big issue.
Laws Covering Genetic Privacy Not Comprehensive
Many privacy experts are concerned that the only law currently covering genetic privacy, the Genetic Information Non-discrimination Act (also known as GINA) is too narrow in its focus on banning employers or insurance companies from accessing this information. Other than GINA, there really is nothing.
Obviously, this is not a risk that the genetic-testing industry alone faces, but it is an industry that has a unique set of information on its consumers. And there was a recent hack in the space. More than 92 million accounts from the genealogy and DNA testing service MyHeritage were found on a private server, the company announced earlier this month. DNA data, specifically, was not breached, the company said. But a hack in this space is a concern, regardless.
A Company’s Situation Can Change
Unintended consequences — not just acute incidents like hacking — are also inherent in this business model’s risks. Companies change — they are bought, sold and go out of business — and what happens to your data then?
Who May Profit From Your DNA Unclear
One of the most compelling signs that consumers have a positive view of these companies is that a majority agree to let them share DNA with researcher partners. All of these companies make clear that they will not share your DNA with any third-party unless you explicitly consent to it, but as 23andMe data shows, the vast majority of consumers opt in.
People do think they are helping the world, helping society, even though they may not as an individual benefit. But if your DNA helps develop a drug for a pharmaceutical company, there is nothing governing what they do. It could be a drug they sell at a high profit but doesn’t help the world become a better place.
Genetic testing services let consumers analyze their DNA to learn about their heritage, their relatives, and their risk for certain heritable diseases. But access to such personal data hasn’t been without controversy, stoking privacy fears.