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While startups are always looking to disrupt established industries, healthcare has been a tricky one as it is heavily regulated by the government as well as strongly influenced by large pharmaceutical companies.
The latest business model taking hold is called “commercial” or “personal” genomics. These companies will compile a customer’s personalized genetic blueprint for a fee, using in-house medical doctors and scientists to determine the buyer’s susceptibility to various illnesses and diseases along with ways to prevent those outcomes. The optimistic viewpoint of this industry is that it gives full accountability to customers. People can now obtain a second opinion outside of their physicians and have an instruction manual of sorts, specific to their own genetic makeup.
Unfortunately, a commercialized approach to this type of genetic testing can influence patients to request drastic – and sometimes unnecessary – medical procedures from their doctors. It can lead someone with no medical background to come to conclusions too quickly about their health and genetic makeup.
A popular company that has made headlines recently is the Google-backed company 23andMe. The FDA is particularly concerned that 23andMe’s results could be misinterpreted by consumers, who fail to realize that these genetic screens only show an increased probability or higher degree of risk for the diseases and conditions tested. The company cannot definitively tell you if you’ll develop Parkinson’s in the next 10 years; it can only suggest that the likelihood is high, relative to other people.
Hank Greely, a professor at Stanford’s Center for Law and the Biosciences, said the term “accuracy” is highly complex. He argues that 23andMe’s analytic accuracy is good, but it lacks clinical validity, meaning that the results should not be used to diagnose patients. “I’m also confident that almost all of the health conditions they report have poor to terrible clinical validity,” he said. “One can’t really believe the health consequences will be as advertised.”
Though the medical field is always in need of technological and scientific advancement, we are still in the early stages of making DNA tests available to the general public. It is understandable from a business perspective to offer a service that people find useful and will pay for but until these tests are proven to have error rates near zero, the public may not be ready to have the full knowledge it provides.
These tests can provide relief to some or the opposite if a life threatening disease seems imminent. The best way to view these tests is with intelligent skepticism, and to leave the responsibility of medical diagnosis to the experts.
Biomedicine is always changing and it is something we are deeply passionate about. For the latest news and regulation changes subscribe to our newsletter, you’ll be well informed on all the latest industry developments.
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