FDA approves 23andMe at home genetic testing kit

Using genetic testing kit a bit like spitting in the wind

As you might know from personal experience, some things are best left to the pros!

Where your home is concerned, fixes like electrical repairs, complicated plumbing issues or patching the roof should probably have you asking for referrals instead of reaching for your tool kit.

And the same thing applies when it comes to trying to unravel the highly complex world of genetics.

Which is why so many who have spent so long studying and practicing in this field were utterly shocked when the FDA just allowed genetic testing kits to be marketed directly to consumers.

The idea is to send in a saliva sample and the company will analyze it and tell you if your genes say you’re more likely to get one of ten big diseases — including Alzheimer’s.

But before you reach for your credit card to order one of these kits, you need to know that it’s not quite as simple as it sounds.

A slippery slope
Like a fortune teller with a crystal ball, genetic testing appears to be a sure-fire way to find out if someone is more likely come down with a terrible illness.

But while it seems scientists know so much about DNA (police are able to catch crooks with just a cheek swab, right?), it’s got a whole lot not going for it if you’re not trained in how to interpret the results.

And despite the glowing reports you may read about this product, as two experts, both with the Division of Bioethics at New York University Langone Medical Center, have said, “genetic testing is still in its infancy.”

Plus that, they added, knowing what it might “mean for you,” is something that requires a professional, a “trained genetic counselor” to advise you what to make of your results. It’s all about “risk and probabilities.” And that’s not as easy to unravel as you might think.

Despite all the cons involved in do-it-yourself testing to find out if your genes are leaning you towards Alzheimer’s, Parkinson’s, certain blood, lung and liver diseases and several more deadly ailments, the FDA went ahead and approved it, all from a company called 23andMe (named after the 23 pairs of chromosomes people have).

This company isn’t a newcomer to the idea. In fact, 23andMe tried this before, but the FDA made them pull their DIY testing kits off the market four years ago saying it was “concerned about the public health consequences.”

But that was then. Now, the agency has decided that the instructions are “easy to follow and understand.”

But what caused the FDA do such an about-face, which not only opened the door for 23andMe, but any other company that wants to get into the act?

Don’t bother asking, because all you’ll get is some “agency speak” saying things like “special controls,” and a “streamlined, flexible approach.” To top that off, in its press release the FDA said that the tests “cannot determine a person’s overall risk of developing a disease or condition.”

Well, FDA, try telling that to someone whose test appears to indicate they’re a potential goner from one of the diseases these kits test for.

It should be obvious that 23andMe customers will be taking the results a lot more seriously. And the company knows it. On the FDA-approved labeling for the test kits it says that being anxious about your results is normal, and if you’re feeling too nervous over the outcome to talk with your doctor.

Genetic testing is certainly a remarkable science that will only be getting better. But if you want to play along, it’s best done under the supervision of a pro who knows what it all means and how to interpret the results correctly.

Otherwise you might be opening yourself up to a lifetime of unnecessary anxiety.

“The FDA’s 23andMe decision will also change the rules for all at-home medical genetic testing” Dave Gershgorn, April 10, 2017, Quartz, qz.com