ARE we witnessing the beginning of the end of 鈥減ersonal genomics鈥�? After a last week, and with the Food and Drug Administration flexing its regulatory muscles, that is what some commentators predict.
鈥淭here鈥檚 no question that the sheer scale and ferocity of this combined inquisition from the FDA and Congress will forever change the face of the personal genomics landscape,鈥� , predicting 鈥渆xcessive, innovation-crushing regulation鈥�.
But this doesn鈥檛 have to be the end of the industry. If it embraces sensible regulation, then it has the chance to shift personal genomics from a minority recreational pursuit to the heart of clinical medicine. We all stand to benefit from such a shift, by being prescribed drugs that work better for our particular genetic make-up, for example.
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The star turn at last week鈥檚 congressional hearing was a (GAO) in which investigators recounted their experience of submitting samples for DNA testing to the four leading personal genomics companies 鈥� , , and . Like others who have had their genomes scanned by different firms, the GAO investigators obtained varying predictions of their risks of developing common diseases.
This is not surprising, given that the companies use different combinations of genetic markers and different algorithms to make predictions from these markers. More damning was a between undercover GAO investigators and representatives of genetic testing firms, including two of the personal genomics companies. Congress heard evidence that a Navigenics sales rep offered ill-informed advice on the genetics of breast cancer. And while New 杏吧原创 warned last year of the potential for genome scans to be abused by people submitting samples from others obtained without their consent, Congress heard that one of Pathway鈥檚 sales team actually encouraged someone to send in a sample from her fianc茅 for testing for disease risks without his knowledge.
Some form of regulation is clearly needed. If it is not too heavy-handed, the FDA鈥檚 involvement could help move the industry into the mainstream. Genome scans could be useful in predicting a person鈥檚 response to commonly used drugs, helping to determine, for example, the optimum dose they should receive. If so, then FDA involvement will be crucial as drug labels will need to indicate how prescriptions should be modified in the light of genetic information.
The future for the personal genomics industry may lie in working with doctors and health insurers to test patients and help improve clinical practice. Navigenics is already working . Given the for curiosity鈥檚 sake 鈥� just a few tens of thousands are thought to have purchased scans so far 鈥� simple economics may send others down the same path.
