If you could look into a crystal ball and see your future health status, would you do it? What if there were a simple test to make it possible? Would knowing the risks of getting sick in the future make you change your behavior?

In 2007 a company named 23andMe decided to find out. Personalized genetic testing was offered, done by a simple saliva sample, and sent away to a laboratory for analysis. Initially, it was quite expensive — almost $1,000 — but as time went on, the cost dropped to $99. Diseases such as Alzheimer’s, diabetes, breast cancer and many more have been linked to certain genetic markers, and people could now test to see if they had an increased risk of them.

More than 700,000 people decided they wanted to know. They ordered testing kits to be delivered to their homes and provided saliva samples for analysis. After a few weeks, each received a package in the mail listing their genetic results, including potential risks for future illnesses based on an analysis of their DNA.

DNA Helix

The double helix structure of DNA, which carries genetic characteristics.

Christian Ude via Wikimedia Commons

Genetic testing has been available to medical scientists for a decade, but making it accessible to consumers for such a reasonable cost was a revolutionary idea. Putting the power in the hands of the people, letting those who want to know their medical future make the choice to find out.

Insurance companies didn’t have to pay for it, doctors didn’t have to order it, and the whole thing could be done from the privacy of home. It truly was a way to empower patients to make their own decisions about their health.

After all, no one ever claimed that having a genetic risk was equivalent to having the disease. But knowing more about what could happen might just change what someone does today to prevent it.

The possibilities seemed endless. However, it all came to a crashing halt in November 2013. The Food and Drug Administration declared that all commercially available genetic testing services were banned in the United States. The theory was that it was a medical device of sorts and therefore required FDA approval.

Concerns brewed over the accuracy of the testing. Those concerns were ultimately resolved when studies showed it to be similar in accuracy to testing done at research laboratories. In fact, one of the tests offered by 23andMe was recently granted FDA approval because of the documented accuracy.

The FDA based its decision on fears that people might misunderstand their results or panic and rush to their doctors’ offices for unnecessary testing. But those fears also proved to be unfounded. In a study of people who have had these tests done, there were no documented negative psychological effects of learning their genetic information from commercial testing.

So what’s the hold-up? It’s been over a year and a half, and the genetic testing offered by 23andMe is still not authorized by the FDA to be done in the United States. But just across the pond, the United Kingdom is moving boldly ahead.

Three months ago, officials from the UK’s Medicines and Health Care Products Regulatory Agency (England’s equivalent of our FDA) approved the use of commercial genetic testing for their residents. The theory was that it helped patients become better informed about their health and future medical decisions. Caution was advised, but the test was not restricted in any way.

Why can’t we make this available once again to people in the United States?

The implications are enormous. Knowing the risks for diseases such as Alzheimer’s, for instance, might make people more proactive in treating their condition. The current medication used for this disease only works in the beginning of the disease process, far before anyone reports routine memory losses. Starting medication earlier could help prevent the disease from progressing.

Type 2 diabetes, which is now known to be a result of more than one genetic mutation, could be managed better with the right medicines. Not all medication works for everyone; knowing which gene is involved would make the choice of treatment more personalized, and not based on trial and error, as it largely is now. This could be especially significant in Hawaii, where Native Hawaiians, Filipinos and other Pacific Islanders are at greater risk of diabetes than other ethnic groups.

Cancer risks can be discovered, and those whose genes show them to be at higher risk for breast and ovarian cancer can be given the choice to act before they develop cancer by having more advanced screenings or even prophylactic surgery.

Right now, doctors and insurance companies decide who can receive genetic testing, and for what genes. The decision is not in the hands of the person most affected: the patient.

It’s time we follow the lead of the UK and allow commercially available genetic testing to be offered once again here in the United States. We should all have the chance to decide whether we want to know our medical futures.

I’m going to be first in line!

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