FDA, 23andme, and Innovation

http://archetyp.al/blog/2013/11/26/fda-23andme-and-innovation/

by excid3 • 13 years ago

12 5 13 years ago

codex• 13 years ago

I think the issue is that 23andme has no rigorous data on what the false positive and negative rates are. Unless they can supply that it's snake oil. And I say that as a 23andme customer.

Symmetry• 13 years ago

23andme has always been regulated as a clinical laboratory, the same as any other genetic testing laboratory. What's different with 23andme is that besides just telling you that you have a certain BRCA mutation, 23andme goes on to say that based on current research that suggests you might have a higher risk of breast cancer. It's that later part which the FDA says pushes 23andme from being a genetics lab to being a medical device.

marris• 13 years ago

Why did you use such a dangerous product?

Unless the kit includes a self-mastectomy tool, I don't think the FDA should get hysterical.

dbcooper• 13 years ago

This is the bit on their marketing that Derek Lowe highlighted from the FDA letter:

For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) 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.

http://pipeline.corante.com/archives/2013/11/27/23_and_me_an...

streptomycin• 13 years ago

23andme provides answers to specific questions like “do I have the BRCA mutations which make me much more susceptible to breast cancer?”

Just so anyone is not misled... 23andme tests for some BRCA mutations, but not all. From https://customercare.23andme.com/entries/23241132-Does-the-2... "The BRCA Cancer Mutations (Selected) report includes 3 selected BRCA mutations. The BRCA mutations covered by this report are only three of hundreds in the BRCA1 and BRCA2 genes that can cause cancer."

I believe the reason is patents on tests for other mutations.

I think this is a good example as to why the marketing behind this type of test is important. If some people are misled into thinking that 23andme tests for all BRCA mutations (keep in mind that most people probably don't even know there are many different BRCA mutations), that could be dangerous. The page I linked to is clear on the issue, but their more prominent marketing is (was?) much more flamboyant.

FDA, 23andme, and Innovation

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