Health Care

Should FDA Deregulate Direct-to-Consumer Genetic Testing?

Many have already commented on the United States Food and Drug Administration’s (FDA) notification to 23andMe – and other personal genomics companies – that these tests belong in the category of medical devices, and consequently under the FDA’s regulatory purview. However the debate is livelier than ever as 23andMe finally removed all health-related information from its genetic reports in late 2013, leaving consumers with only ancestry-related genetic reports and uninterpreted raw genetic data.

Four key speakers were invited by OBR to debate this important topic on Monday night:

Paul Billings – Chief Medical Officer, Life Technologies Corporation; Advisor at 23andMe and also at the FDA board

Andro Hsu – Director, Product Marketing at Syapse Inc. (early employee (number 10) of 23andMe)

Gianfranco de Feo – VP Marketing, Bina Technologies which commercializes software and hardware products for next generation sequencing analysis

Patricia Zettler – Fellow, Stanford Law School Center for Law and the Biosciences.  Previously, she was an attorney at the FDA on drugs.

Beyond the terminology issue on classifying 23andMe’s disease-risk genetic tests as medical devices, there is a profound debate to be held on how to deal with direct-to-consumer genetic testing. Indeed, we are not far from a time when everyone will be able to get his genome sequenced and find open-source software on the web to interpret it (Promethease is already providing such services). It was amazing to see that in the UCSF Genentech Hall, more than 50% of the attendees had already tested their genome with 23andMe.

Exercising the precautionary principle, the FDA claims that false-positive or false-negative test results could distress consumers and cause them to make drastic changes affecting their health. Consequences could go way further as argued by supporters of the FDA regulation: if only one person makes a wrong decision that results in death, it would be a complete disaster for all the R&D efforts around genomics and personalized medicine.

But isn’t it more dangerous to give people raw data, and absolutely no clue on how, to interpret these? Are we not going to miss opportunities? Empowered patients and consumers are clearly drivers to improve healthcare in the US, all the more as this information is personalized. Moreover, there are clear benefits among consumers of personalized genetic tests like changes to diet, exercise, subscribe to a health-insurance company and of course consult their doctor. 23andMe and others are building a massive bank of genomic data that has a huge potential value for research.

Questions are still open on the future of health-related information. It is a complex debate mixing science, regulatory and ethics. For now, most physicians are confused when a patient comes with information coming out of 23andMe and other DTC genetic testing companies. Exploring ways on how to get physicians involved in the process would probably be another key question to be asked for any future developments. And as the FDA pointed out, accuracy of the results is not proven and research is definitely still necessary in this field.

 

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