The FDA Shuts Down Home Genetic Testing Company 23andMe

On Monday the US Government FDA forced the main home testing company 23andMe to stop selling its saliva genetics home testing kit. As this is their only product this means that they effectively shut down their operation.

Looking at Genes

The problem seems to be that the company is offering testing for gene mutations that may lead to rises in probability of contracting diseases. This is considered a medical test by the FDA, and so they require trials and results in order to see how well the tests work before they license them. 23AndMe have been unable or unwilling to provide such results, so cannot market their device unless they take away all of the medical arguments.

This is the technical reason, but there are serious ethical issues surrounding home genetic testing. The following are just a few of my own ideas:

Without serious research doubt must remain about the quality of the results. The samples are not second tested, and the quality of testing cannot be of the same level as other medical hight cost exams. There have been problems reported due to the small number of people involved in the test groups, as statistics require masses of data that are not yet available.

Are customers qualified to interpret the results? What does a statistical rise in probability actually mean to a person that has never studied statistics or probability? And the results are delivered without any counseling, so if there is bad news the customer is left to process the information alone.

Here just a few examples might demonstrate the difficulty. If I have a 1% chance of contracting problem A, but I have a gene variant that means that I am 70% more likely to contract it, I might be distraught. The reality is that I now have a 1.7% chance, very little difference, but I might try to change my lifestyle, treat my kids differently, get paranoid, have preemptive surgery, who knows how an individual will react without medical advice?

If on the other hand I am negative for a mutation for something I might adopt an equally problematic stance. I don’t have the gene mutation that leads to skin cancer so I can stop worrying and have another hour on the sun bed. Social factors are really the big ones in many cases.

And what about testing your children? How will parents react knowing that their child might be susceptible to certain problems later in life?

Oh and if I discover that I have something hideous, should I tell my brothers? They might carry it and pass it on to their children. How personal is this type of medicine? It is familial, not individual.

The 23andMe problem is a prime example of money ruling. They have operated for 6 years, without regulation and blatantly challenging the FDA and medical profession that they see as holding up progress. As far as I can see this is about as far away from the responsible innovation that I have spent my recent life trying to promote as I would like to see anyone go. I would add though that it is a systemic problem here in the USA, not a personal divisive choice, and it is very different to the European approach underscored by the precautionary principal (with all its critics).

For further reading you will find several of my articles linked through this post on the same subject from last year.

The National Post has a good article too that includes both sides of the argument.