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Lawmakers Issue Dx Reform Bill To Strike Regulatory Balance

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.

WASHINGTON, DC - MAY 20, 2019: US SENATOR RICHARD M BURR NORTH CAROLINA - office entrance sign

Four top US congressional leaders have introduced the Verifying Accurate Leading-Edge IVCT Development (VALID) Act, which aims to dramatically change how the diagnostics industry is regulated.

Sens. Richard Burr, R-NC, and Michael Bennet, D-CO, proposed the VALID Act in the Senate on 5 March, while Reps. Diana DeGette, D-CO, and Larry Bucshon, R-IN, introduced an identical...

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