Pharmaceutical Companies are not liking this at all.
Purchasers of 23andMe (http://www.23andMe.com) Health + Ancestry DNA test now have access to genetic health risk reports for conditions including late-onset Alzheimer’s disease, Parkinson disease, Celiac disease and seven others.
This is a big step, if incremental, step forward for the company. Its DNA service initially provided ancestry information and genetic risk reports on about 250 conditions. In 2013, the FDA ordered 23andMe to stop providing health-related information to US customers because the company hadn’t proven its test were analytically or clinically validated.
The new reports calculate genetic risk based on the presence (or absence) of specific markers in a person’s DNA. To obtain FDA authorization for them, 23andMe conducted “extensive validation studies for accuracy and user comprehensive that met FDA standards,” according to its announcement. FDA considered evidence tying each condition with relevant genetic markers in customers’ DNA.