FDA wants to ban genetic tests by Google-backed 23andme

23andme is one of the companies I am always fascinated about from a BigData perspective as they have access to huge amount of data that can dramatically change the healthcare systems in the world and and I have discussed this in many conversations with my friends and colleagues.

About 23andme

23andme is a DNA analysis company and is backed by Google. How does it work? Well you order a kit and provide saliva sample and send your kit back to 23andme. The company runs a DNA analysis and then provides details about your health risk, carrier status and drug response based on a detailed genetic analysis. Why do you need it? Knowing your health risks will allow you to manage your health better and can make some lifestyle changes and take some preventive action. Additionally, you can find out fun stuff, like if you have ancestors in another country. For example, DNA tests reveal that Prince William has ancestor in India.

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Why is FDA worried?

It all sounds great but then why is Food Drug & Administration (FDA) worried? FDA is worried about potential pitfalls of false positive and false negative about health risk assessment and drug response. For instance, a false positive on risk assessment on breast or ovarian cancer could lead a patient to undergo prophylactic surgery or chemotherapy. While a false negative could lead someone to overlook an actual risk that may exist. FDA is also worried if drug response test will lead patients to self-manage their treatments by dose changes or stopping certain drugs.

The real issue is not that the tests are bad – these tests bypasses a physician’s presence and his assessment of patients health and response and expose consumers to the risk of trying to self-manage their own treatment of serious diseases or if incorrect test results are reported.

What 23andme should do is to prove to FDA that the tests work and are accurate. Easy problem you data scientist, huh? It should also educate the consumers about the risk that are inherent in such tests and provide guidance to consumers on how to use the results.

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