If you have thought about using on of the genetic test kits that only require you to spit in a cup and mail it in, the government wants you to think twice. In an undercover investigation the Government Accounting Office found them unreliable and of little use.
While all the tests have been available on the internet, Navigenics, deCode, Krome Inc., Pathway and 23andMe all came under GAO scrutiny when Pathway proposed selling their tests at Walgreen’s in May.
In the investigation 5 persons sent samples to 4 companies, when compared to their personal and family medical histories, the tests were wrong 68% of the time. In one instance a man, who uses a pacemaker for atrial fibrillation, was told that he was at low risk for the condition.
The report stated that the tests were, “misleading and of little or no practical use to consumers”.
The GAO has sent all five companies a letter informing them of their intent to bring them under FDA regulation. None of the firms had sought approval by the FDA earlier.
The companies have defended their product saying consumers have the right to know their own genome in order to make informed health decisions.