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European Biopharmaceutical Review

In Your Genes

In April 2017, the FDA formally approved the sale of direct-to-consumer genetic testing for 10 disease indications and established a framework for future approvals. This opens up the field to consumer genetic tests that are both accurate in their readout and significant in their interpretation. It places the US market on the same playing field as Canada and UK – but the move is not without controversy.

Advances in genomics have stimulated great interest as a tool for drug discovery, as a means of disease diagnosis and treatment and as an additional way to make sense of individual prognoses. Particularly in the consumer health arena, breathtaking advances in science have captured the public imagination as a possible way to predict future health outcomes. As a sidebar, the ancestry interpretation of personal genomics has become very popular.

The recent FDA move concludes four years of restrictions placed on claims and product offerings by the personal genomics company 23andMe. This was a time to validate the accuracy of the lab work, scientific significance and clinical relevance and to address concerns about the consumer-facing documentation and interpretation. Doctors had often been faced with difficult patient questions like, ‘how much does this increase my risk?’

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Emile Bellott is a member of the EBR Industry Advisory Board, and an industry consultant, with experience in drug discovery, development and pharmaceutical outsourcing.
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Emile Bellott
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