In Case You’re Considering Using a Home Genetic Test, Don’t.

Consumers like to cut regulators and other authoritative bodies out of their transactions with health with health information providers.  Just look at the enormous sales achieved by non-regulated treatments, such as herbs and mineral supplements.  Now enterprising companies are promoting their home genetic testing kits.  The US Government Accounting Office has investigated the reliability of such services, and found them wanting, according to a Reuters report.      

The investigators employed 5 volunteers who sent their saliva samples to 4 unnamed genetic testing labs.  Four of the 5 got results that conflicted with their actual medical conditions and family histories.  The costs to the consumer ranged from $300 to $1,000.

It’s obvious that such testing systems are crying out for regulation.  The Food and Drug Administration (FDA) has recently become more aggressive in controlling companies that step over the line.  This Agency is now preparing to regulate the sales of home genetic tests.  They have already sent letters to Pathway Genomics, Knome Inc., Navigenics Inc., deCODE Genetics, and 23andMe.  According to the FDA, these companies’ products meet the Agency’s definition of a medical device, and should be regulated accordingly, so that the consumer can trust the product.

It’s clear that the results of home tests being promoted directly to the consumer have little or no value.  If you’re considering trying such an offer, we recommend you don’t.  Go to your family physician, who can direct you to a recognized practicing geneticist for reliable testing.  But on the way there, consider what you will do with any results you may get.  For instance, would it help you, at age 50, to know if you have a genetic likelihood of contracting Alzheimer’s disease when you are 75?