There was a surprising amount of resistance yesterday regarding the FDA’s letter warning the genetics company 23 and Me about marketing their test as a diagnostic service.
To clear up a couple of issues:
1. The FDA is not requiring 23 and Me to stop administering the test. The FDA is requesting 23 and Me stops marketing it as a diagnostic test without having previously proven efficacy.
2. The FDA is not solely against 23 and Me. While the most high profile, the FDA has been targeting similar low-cost genetic companies over the past three years asking companies to provide the necessary analysis to validate their claims.
The broader issue is that while the cost for sequencing continues to decline, the cost of analysis is still relatively high because we don’t enough understanding to remove humans from the process (yet.) As companies like Moleculo (Illumina) and others continue to drop the cost of full long read sequencing (and your biology becomes more like code), this will eventually change.
In the short-term, the FDA is doing the right thing by preventing a test from being marketed for something its not – a diagnostic.