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Lawmakers Issue Dx Reform Bill To Strike Regulatory Balance

Executive Summary

After failing to gain traction last year, a couple of US lawmakers are hoping to garner support for a pair of bills that would require certain diagnostic tests to be regulated by the US FDA that are currently outside the scope of the agency’s oversight. The bills are intended to be a solution to concerns that certain tests do not require adequate proof of safety and effectiveness, which could lead to misdiagnoses.

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