The FDA’s activities concerning 23andMe’s personal genetic testing kit center around the idea

that the information the patient receives from the test is considered medical advice. Any
healthcare tool that offers medical advice must be approved for use through the FDA. In its
letter, the F.D.A. seems to argue that it’s not the actual DNA genotyping microarray that it sees
as the medical device but, rather, the combination of the assay and the company’s offer to tell
customers what the assay means (Dobbs, 2013). 23andMe has been selling the personal genetic
testing kit without FDA approval and so the FDA issued a mandatory withdraw of the product
from consumers
The decision by the FDA to block 23andMe from marketing their personal genetic testing kits
came from the understanding that the testing system has the potential for errors from the
complicated process of collection, transport, and mapping. 23andMe did not supply the
information regarding this process in detail enough for the FDA.
Another problematic issue surrounds interpretation of test results. The FDA stipulates that the
information received from testing can be used by the patient to make potentially harmful
decisions about personal healthcare. For example, a patient is shown to have no genetic risk for
diabetes through 23andMe’s genetic testing. That patient then ignores a physician’s warning
about the possibility of developing diabetes in the future and does not implement recommended
lifestyle changes base on the information from 23and Me’s genetic test. This patient develops
diabetes in the next year.
23andMe’s genetic testing kit, along with other diagnostic services, need to be run through the
FDA’s review process. These processes determine patient safety and create procedures to ensure
quality healthcare is being given and received.

Breanna,
I agree with you that the next steps are to aim for a partnership between new technologies and
the FDA. We must assume that the FDA has the well being of the population at heart and work
with them to improve patient care and treatment. 23andMe’s genetic testing is a great piece of
medical tech that has its place as a tool for healthcare providers to help inform patients of
possible risk and future treatments. Your statement about customers also understanding the limits
of this tech and meeting with their provider to determine future steps is what should be expected.
Great post!
Samantha,
While I agree with you that 23andMe’s genetic testing kid provided “estimation on disease risks
made by the personal genomic service are based on extrapolations of research associating
specific genetic sequences with the risk of clinical disease, emphasizing the inconsistencies
among the products” I do not believe that was the whole issue the FDA stipulated. Another
factor surrounding the test was the way in which results were viewed by the patient. The
patient, without having medical training, would not be able to interpret the results readily and
correctly. This could possibly lead to patient harm. Test results only do not show what genetic
mapping and counseling provide. Great post!

Dobbs, D. (2013, November 27). The FDA vs Personal Genetic Testing. New Yorker. Retrieved
from https://www.newyorker.com/tech/annals-of-technology/the-f-d-a-vs-personal-genetic-
testing
Downing, N. & Ross, J. (2013, November 22). Innovation, Risk and Patient Empowerment: FDA
Mandated Withdrawal of 23andMe’s Personal Genome Service. Retrieved from
https://learn.umgc.edu/d2l/le/content/515927/viewContent/18907681/View