California Takes Step to Further Regulation of Gene Tests
California has sent cease-and-desist letters to companies that provide direct-to-consumer (DTC) genetic testing. California is worried that the results of the test aren’t very useful for customers, since data on the mutations DTC companies test for are generally limited. Most of the mutations DTC companies test for do not have 100% penetrance – if you have the allele, you will not necessarily get the disease. But the results of the tests may still be somewhat useful now, and probably more so in the future as new data becomes available. Some people clearly want to know – or else they wouldn’t pay for the tests. (Of course, government should ensure that the DTC companies are not providing fraudulent information about their services – but that does not appear to be the issue here.)
California is also attempting to check that the tests customers ordered were prescribed by a doctor – a ridiculous requirement, given that conducting a genetic test does not put the patient at any risk (unlike, say, a heart stress test).
Part of the problem is that DTC companies do not perform the sorts of simple diagnostic tests that could predict diseases with more certainty (on alleles with higher penetrance) – because, Ars notes, the FDA heavily regulates such tests. Ars sees California’s latest move as a step toward expanding regulation of all genetic tests. Instead, the government should go in the opposite direction: enforce fraud laws to ensure that no spurious claims are made, but allow customers to get their genes tested without extensive FDA regulation or even a doctor’s order. It’s a sad world where we have the technology to know who we are genetically, but the state won’t let us find out.