Lifted this exscript from new next gen. sequencing government guidelines. Just remember, I'm from the Government and I'm here to help you. Below is the link to the rest of the story.

The guidance applies solely to “targeted and WES NGS-based tests intended to aid in the diagnosis of individuals with suspected germline diseases or other conditions.” However, the FDA repeats its implication that there is something inherently more dangerous or risky about direct-to-consumer (DTC) access to results as opposed to results obtained in a healthcare setting, noting that for DTC delivery “additional recommendations and controls would be needed.”

http://www.genomicslawreport.com/ind...on-sequencing/