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Comment by mkopinsky | Hacker News Reader

The lesson here is don't use shoddy diagnostics. CT is a proven technology, which gets things right the vast majority of the time, and also has a false positive rate. 23andMe is relying on technologies or algorithms that have not undergone the requisite scrutiny to lose the label (in the FDA's opinion) of "shoddy diagnostics", and are thus far more likely to have a higher false positive or false negative rate.

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Isn't the lesson here not to rely on any one source of diagnosis?

There have always been differing medical opinions, so allowing patients to cheaply sample many in order to rapidly get to the end is better than having a one off rarely in practise used test because it's prohibitively expensive.

The FDA are simply enforcing the medical industry monopoly on diagnosis. You can expect any potentially disruptive effort along these lines to also mysteriously fail to ever be approved.

> The FDA are simply enforcing the medical industry monopoly on diagnosis.

23andMe could sell their product as not being diagnostic. Since 23andme chose to sell their product as being diagnostic it's fair enough that their held to the same level of regulation as everyone else in the sector.

They explicitly did not. From their TOS:

As a result of the current state of genetic knowledge and understanding, our Services are for research, informational, and educational purposes only. The Services are not intended to be used by the customer for any diagnostic purpose and are not a substitute for professional medical advice.

The TOS is irrelevant if they're elsewhere making diagnostic claims.

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