Ok....so I have been reading Hsien's discussions about DTC testing good or evil?
This spirited debate is very important. Everyone has concerns about regulations. It is the reason why 23andMe jumped the non-clia certified lab ship (And probably Why Andrew's results were delayed) But it is also why LabCorp has now locked out all other corporate genomic companies for now....
"Predisposition is Pre-Disease". This is the case with BRCA testing, it is the case with some robust SNPs. The ICD10 codes will catch up with this....
If it is not the case (i.e. for entertainment purposes only, NO HEALTH IMPLICATIONS) then they don't need medical regulation.
So I ask, are the SNPs which are being tested for and reported robust? Are they medically actionable? If so, then you are absolutely practicing medicine...You can't deny that at all..........
Once again from Dr Ralph Snyderman,
Today, most health-care expenditure is focused on the later stages of this process, long after the development of many underlying pathological changes. Until recently, it could be argued that the focus on treating disease was justified because the ability to predict, track, and prevent its onset was not technically feasible. This is no longer the case, and the emerging sciences of genomics, proteomics, metabolomics, medical technologies and informatics are revolutionizing the capability to predict events and enable intervention before damage occurs. Personalized risk prediction and strategic health-care planning will facilitate a new form of care, which we have called 'prospective health care' [1].
The Sherpa Says:
So is it really over-regulation? Or is it just calling some genomic tests "The Practice of Medicine". Which brings up an even more interesting point. Why would anyone want "health related genetic tests" if they Weren't diagnosing a Pre-Disease?
So is it really over-regulation? Or is it just calling some genomic tests "The Practice of Medicine". Which brings up an even more interesting point. Why would anyone want "health related genetic tests" if they Weren't diagnosing a Pre-Disease?
2 comments:
Hi Steve,
Do you think tests for mutations of high penetrance and low penetrance should be equally regulated? Or, when exactly does a test for a mutation or mutations become a diagnosis of predisease?
-Kevin
Well,
I think you would have to ask the corporate genomics companies when a test becomes a diagnosis in their eyes.
Personally, I don't think any test should be offered UNLESS it is that test of predisease. Why? Because otherwise....(In this simple doctor's humble opinion).....it is noninformative. Would consumers looking for healthcare related testing want to know about something if it wasn't linked in anyway to getting a condition or having a particular health outcome? Otherwise, this whole testing business is like reading tarot cards....or fortune tellers, that give you vague, generalizable information that may not be specific to you at all.
If I was building a consumer genomics company I would use DVPMP's model. Which means, you will be involved in the practice of medicine. This is something that is inevitable....(ITSDHO)
But to answer the question
Low or High penetrance doesn't matter....especially when viewed with a family history (modifier genes and environment)....so that question is really irrelevant, I think.
-Steve
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