3 ms·

no. the symptom checker is just a document. it is a not a device or an ingested substance.

Dylan16807 13y ago
23AM's offering is in two parts. First, they do some genetic mapping. Second, they do an analysis on the markers found. The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.
- smackfu 13y ago
  Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
  - Dylan16807 13y ago
    There is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
    - smackfu 13y ago
      To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.
- jes5199 13y ago
  It seems to me that it's the link between those two parts that is problematic! If someone sold genetic tests that just output a list of markers, and the clients consulted publicly available literature to discern the meaning of those results, then no one would have taken the responsibility of giving advice to a client. By packaging a specific, curated set of information with the test results, 23andme has crossed over from offering tools to offering expertise - and has therefor taken on responsibilities.

23AM's offering is in two parts. First, they do some genetic mapping. Second, they do an analysis on the markers found. The objections are based on the second part (and the marketing for it), which seems by itself to be very equivalent to WebMD. I don't think there's any suggestion that abstract-genetic-marker-finding is the problem here.

smackfu 13y ago
Any lab test is going to have those two parts, a lab procedure and an analysis. I would expect both parts to be governed by the FDA to ensure reliable results.
- Dylan16807 13y ago
  There is a difference between mechanical analysis and medical analysis. Obviously they need to analyze the raw signals coming out of the machine to figure out what markers are present. But they could stop there, saying "with four nines certainty you have genes ABJ2, CBI8, LOC9, JOLO, ZZT". The FDA is objecting to doing a medical correlation/explanation beyond that point, doing the things WebMD does.
  - smackfu 13y ago
    To be honest, I think they have to do both things to get regulated under the FDA. The FDA is involved because they consider it a "device" that is "intended for use in the diagnosis of disease or other conditions." If they just did the analysis based on provided data, I don't think that would count as a device.
jes5199 13y ago
It seems to me that it's the link between those two parts that is problematic! If someone sold genetic tests that just output a list of markers, and the clients consulted publicly available literature to discern the meaning of those results, then no one would have taken the responsibility of giving advice to a client. By packaging a specific, curated set of information with the test results, 23andme has crossed over from offering tools to offering expertise - and has therefor taken on responsibilities.