3 ms·

In order to ensure that the risks are balanced, they need to evaluate the expected value of false negatives vs false positives. If they don't have this informat

In order to ensure that the risks are balanced, they need to evaluate the expected value of false negatives vs false positives. If they don't have this information, they are regulating blind. If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing. The FDA can play a role if they want to independently test sequencers and publish data like the highway safety council and crash test ratings, but I see no reason to "regulate" genetic sequencing anymore than someone should regulate mass spectrometers.

timr 13y ago
"If they don't have this information, they are regulating blind." Yes, exactly. That's why they've been asking the company for that information for months, and why they shut down sales of the product until the company complies. Glad we agree that this is the right move by the FDA. "If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing." They aren't sequencing anything -- they're using microarrays. How can you possibly have such a strong opinion on something that you know nothing about?
cromwellian 13y ago
Well, excuse me for being lazy and using less specific terminology than you desire. Yes, I know how 23andme's SNP probing works. I just prefer to imagine a personal genomics market in general that evolves to the state where we can all have our full genome sequenced. And we're not going to get there without having early adopters and baby steps instead. I don't need government protection from this, certainly not over a one time fee of $99 that has ample disclaimers, and at worst, will cause me to waste time asking my doctor over a condition I don't have, and at best, find out the cause of a disorder that doctors haven't been able to diagnose. Yes, and in some very rare cases, some people will be told they don't have the BRCA gene when they really do, as if there's an epidemic of women have been avoiding mammograms because of DNA tests, instead of lacking healthcare, or being given confusing directives over the years over when, and how often they need to have exams.

timr 13y ago

"If they don't have this information, they are regulating blind." Yes, exactly. That's why they've been asking the company for that information for months, and why they shut down sales of the product until the company complies. Glad we agree that this is the right move by the FDA. "If 23andme's gene sequencers are inaccurate, then I expect market competition between competitors over who has the most accurate sequencing." They aren't sequencing anything -- they're using microarrays. How can you possibly have such a strong opinion on something that you know nothing about?

cromwellian 13y ago

Well, excuse me for being lazy and using less specific terminology than you desire. Yes, I know how 23andme's SNP probing works. I just prefer to imagine a personal genomics market in general that evolves to the state where we can all have our full genome sequenced. And we're not going to get there without having early adopters and baby steps instead. I don't need government protection from this, certainly not over a one time fee of $99 that has ample disclaimers, and at worst, will cause me to waste time asking my doctor over a condition I don't have, and at best, find out the cause of a disorder that doctors haven't been able to diagnose. Yes, and in some very rare cases, some people will be told they don't have the BRCA gene when they really do, as if there's an epidemic of women have been avoiding mammograms because of DNA tests, instead of lacking healthcare, or being given confusing directives over the years over when, and how often they need to have exams.