Genetic Testing report - patients need more support
Yay! At last common sense prevails!
The UK’s Human Genetics Commission (HGC) has just issued an enormous tome on the subject of genetic testing called ‘More Genes Direct’ (recommended weekend read!)
The report discusses the imminent explosion of genetic testing and the fact there is very little regulation or independent validation about test claims. The HGC is concerned that in the wrong hands, genetic testing could do more harm than good. This has also been highlighted by the FDA but the FDA has made huge inroads in reviewing, analysing and assessing genetic tests in order to produce gold standard protocols. This I have discovered first hand when I met them in Washington recently and they used Agendia’s Mammaprint breast cancer prognostic microarray as an example of the in-depth analysis they carried out with the company before approval.
I have been preaching that genetic testing needs to be included in a disease surveillance programme that includes proper management of patients pre, during and post testing. I strongly believe that my company Opaldia’s care model has been endorsed by the HGC - a shameless plug but we have one chance of getting it right when introducing genetic testing into mainstream medicine. This is what HGC’s report supports.
Opaldia also reviews every piece of research on a test, meets the team, visits the lab, interviews the scientists and then takes its findings to its Scientific Advisory Board, made up of the great and the good in genetics and medicine. We also take advice from the physicians who will potentially be using the test to assess how they would introduce any test into their clinical practice.
Where I don’t concur with HGC is their conclusion not to introduce genetic tests into the commercial market until more research has been carried out. Having visited numerous labs around the world and interviewed countless scientists, CEOs, founders etc in an effort to understand the science behind each test, the majority of tests coming onto the market are bona fide with years of research behind them. What is missing are prospective trials as the majority of evidence is retrospective. Prospective trials take years and years to gain outcomes. In the meantime technology supersedes the technology of the prospective trial so we enter a cycle of never actually getting anywhere!
Elaine Warburton
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POSTED IN: Genealogy and DNA, General Genetics and Health, Genetic Engineering, Genetic Future, Genetic Ingenuity, Genetic Testing, Genetics of Disease, Personalized Medicine, Pharmacogenetics
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