In the case of Mendelian disorders, if a specific high-risk SNP is analyzed by different companies, then these different companies should report a similar, high risk of showing symptoms of the disorder. If there are SNPs with a similar high risk for the disorder, which are, however, not reported back to the citizen, then the report will state “selected”.

The situation is different for multi-factorial diseases: each company will only test for some of the many SNPs known to have a, often weak, disease-association. Thus, the corresponding disease-risk predictions reported by different companies will naturally be non-identical.

I see no need for a regulatory agency to get involved.

The direct-to-citizen genetic testing companies only provide us with published, public knowledge (“according to the study published in … base … at SNP … is associated with a … higher/lower risk for disease …”). Many of the genome-disease-association studies, both for Mendelian disorders and multi-factorial diseases, were funded by the USA government itself via the NIH (National Institutes of Health). So one arm (FDA) of the government should not prevent the private sector from informing tax-paying citizens what discoveries were achieved using their taxes by another arm (NIH) of the government.

@Bob,
It is by Kant….

Is the Personalised Medicine Coalition doing anything? I read in a December 2007 letter the HHS (bit.ly/bYmpDY pdf) that “PMC is ready to convene stakeholders who could propose such [voluntary] standards to educate consumers and guide the field”. What happened there? Activity on the PMC regulatory oversight section of their website seems to stop at 2007 (bit.ly/dzxQbn)

BTW – congrats to Genome Unzipped so far, the articles and comments have been outstanding

Re: The only debate left here is “What is medical and what is not?” ICD9? ICD10? Medical Scoieties? IOM
How will we really decide that one?
One thing is for certain, it will not be decided by Silicon Valley or in a Genomics Lab.

Well, that is what most of the rest of us following this post are afraid of- “What is medical and what is not” involves a continuum of possibilities that is no more easily discerned by any of our current medical establishments, let alone by the FDA, than by those of us in Silicon Valley or in a Genomics Lab.

BTW, can I borrow your philosophy text?

Bob

The whole business adage of “All ships rise with a rising tide” certainly rings true here. In fact I heard it about a million times when my business buddies tried to get me to drop the blog as it was “bad for business”

It seems to me that the answers to these debates are:

1. Regulation is coming from the FDA not CAP, maybe even for Myriad.

2. The self-regulation thing only works when the self has teeth, think medical licensing boards here…Not country club buddies.

3. Transparency only works if the public can even understand what the hell you are saying. less than 35% of the US public is health literate let alone genomics literate

4. No one is singling out DTCG, LDT is involved here too. Annihilation will occur because
A. the chain of trust is broken, thanks YouTube
B. There is no market
C. Now the expense to operate will become too painful for any supposed hockey stick projection on a napkin

5. The model for regulation is already in place. Amplichip. Speaking up is nice, but there is a model in place. Maybe not for predisposition, but I would say we can find some there as well.

6. The press is on a wave of anger after PR people made them look stupid covering DTCG uncritically. Now they are going after DTCG uncritically. Nuance sells philosophy textbooks.

The only debate left here is

“What is medical and what is not?”

ICD9? ICD10? Medical Scoieties? IOM? How will we really decide that one?

One thing is for certain, it will not be decided by Silicon Valley or in a Genomics Lab.

-Steve

[I guess you mean Mark Henderson? DM]

absolute vigilance – I second that