Personal Genome

There has been an explosive growth in people wanting to get their genome analyzed. The FDA last Friday issued what in my opinion appears to be almost a cease and desist order, or as they phrase it:

must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.

 Specifically the FDA claims:

This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at ... markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

 There always has been a set of concerns here. Most people have no clue what some of these readings mean. Also the reading may be at best reflective a a still questionable result. One should ask even if most physicians have the ability to ascertain the results.

There is also the question of what rights have you lost by sending your DNA to some third party.

This has always been an issue and the FDA may very well have taken a proper and necessary step. It will be interesting to follow this.