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CEO and Founder, Techstars
CEO of Zero Locus
Professor of Systems Biology, Columbia University
Founder and CEO, Acme Packet
Nobel Laureate, Professor of Biology, Caltech
Founder and CEO of Brooks Bell Inc.
Former CEO, Calistoga Pharmaceuticals
Dan Vorhaus is an attorney with Robinson, Bradshaw & Hinson and Editor of the Genomics Law Report. Follow @
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Whether it’s transparency or regulation the DTC genomic data needs to be more fully disclosed publicly. It is fairly well understood amongst genetic researchers that the vast majority of SNP data accounts for a fraction of the total genetic variability of any given person with regards to complex disease let alone treatment options for said patients. Furthermore, the SNP data is non-adative so it is difficult to combine the various alleles into an aggregate risk/prognosis etc.
There are however, other more directed technologies (e.g. http://www.dynemobiosystems.com) that can combine the massive amounts of molecular information within say tumors into an aggregate prognosis or likelihood of response to therapy.
My primary worry with DTC genomic data is that it will poison the well for consumers and medical practitioners to the use of personalized medicine since those technologies will (at this juncture) provide little data to the actual health outcomes of patients.
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Could you elaborate on what is meant with regards to the FDA “dampening crucial innovation in an emerging field, by imposing time-consuming and costly regulatory burdens on genetic test providers”, especially for those of us who are not very familiar with the regulatory realm?
I don’t think paternalism is the goal of regulation on DTC genetic testing. No one wants to tell individuals whether or not to access their own genetic information. However, no one should access their own genetic information without understanding clearly what that information means to them. Uneducated misinterpretation can result in disastrous consequences for people’s health. Additionally, this information not only reveals health information about the test-taker but also about the test-taker’s blood-related relatives. It is important that those consumers consider this information prior to taking the test. Once the results are known, you can’t take them back.
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It is pretty typical that the government wants to regulate something that people should have access to in the first place.
Knowing ones genetic make up can see if they might be prone to some illness that they might not have thought otherwise. Or maybe even give them a glimpse into their genetic background; a glimpse of who their ancestors were.
What a shame.
Boston · 03/11/15
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