What is the Consumer Genetic Testing Industry?
If you are not yet acquainted with the consumer genetic testing industry, here is a quick primer.
Genetic testing had remained confined to the medical field and was simply a particular test a doctor could order. The testing process was often long and seldom affordable, but it could deliver useful information on rare genetic illnesses for which a doctor might want to test. Since the late 2000’s, the technology relevant to reading a human’s genetic information became cheap enough to sell tests on a per-person basis of approximately $100. This low-cost testing technology enabled consumer genetic testing startups to emerge, perhaps the most recognizable among them being 23andMe. What made these companies unique was that they also provided non-medical information and marketed directly to the consumer. Moreover, by mailing testing kits, they bypassed the need to visit a doctor or any physical lab.
For the most part, the test was a matter of shipping off to the company a vial of saliva and waiting a few weeks to receive electronic information on your DNA. The company could then use genetic databases to compare the consumers’ DNA and create analyses for the likelihoods of certain traits. The genetic data would be displayed in a consumer-friendly breakdown of categories ranging from ancestry (e.g. X% Native American) to physical features predictions (e.g. chances of early balding). For several years, these companies served a relatively small consumer population and remained under the radar, until the FDA started to question their practices.
Certain companies, notably 23andMe, were scrutinized by the FDA in 2016 because of concerns over their genetic risk assessments, which were used to report the likelihood of developing certain illnesses, such as heart disease and Alzheimer’s. The FDA’s primary concern was ensuring that consumers were not being advised on medical matters by non-FDA approved entities. For a brief period, legitimate firms in the industry decided to no longer provide health-related information on their DNA feedback, but by spring 2017, the FDA put in new requirements, essentially guidelines to prevent the spread of misinformation. These allowed various types of genetic information to be screened by the industry once again. From then on, companies like 23andMe have given out information that meets FDA requirements on consumers’ risks for developing conditions like Celiac, Parkinson’s, and (fairly recently) breast cancer.
Nowadays, the industry is dominated by two companies: Ancestry.com and 23andMe, with the former holding a considerably larger portion of the market share, largely in part to its long history of providing genealogy information. The current market is at least valued at $100 million, with estimates ranging to the several hundreds of millions of dollars within the next few years, and the total number of people tested by the end of 2017 has reached just over 12 million. Once again, these numbers are expected to grow by the millions in the coming years as tests become cheaper; simultaneously, the information provided can become increasingly nuanced with data improvements and the FDA approval for more health tests. Clearly, the consumer genetic testing industry is on the rise and has begun to resonate with increasing numbers of customers. According to the growing number of interested individuals, this industry has emerged even stronger after surviving regulation. Looking ahead, it is likely that these tests will become more prolific in society, but as technology and industry progress, the ethics surrounding certain tests, such as predicting IQ level, may lag behind, which has caused some voices of concern to be raised. In any case, this industry is certainly one to look out for.