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Consumer Gene Testing in the Hotseat

from Nature News

Companies that sell direct-to-consumer (DTC) gene-testing kits have had a tumultuous time in the past ten days. On 19 and 20 July, at a hearing held by the US Food and Drug Administration (FDA), regulators heard comments from stakeholders about how the government might best oversee the validity and accuracy of such tests and other in vitro diagnostics.

Later in the same week, at a congressional hearing, the US Government Accountability Office presented results from a damning year-long investigation into the DTC gene-testing industry that characterized some of the tests as "misleading" and "of no practical use," and the marketing surrounding them as deceptive and fraudulent.

Many in the field of genomics and personalized medicine--in both academia and industry--concede that regulation is necessary. ... The fear, however, is that government backlash against questions over the tests' validity and inconsistent results from different companies will lead to an overly strict regulatory framework that will crush scientific innovation.

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