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Diagnostics Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

ACLA filed a motion arguing that HHS' PAMA data collection process is flawed. It follows a July decision that overturned a lower court's dismissal of ACLA's lawsuit.

The final guidance seeks to streamline the process, which has typically required separate submission processes for the drug and the device.

While industry organizations remain optimistic the bill will pass, others note challenges, including a lack of strong Congressional support and political gridlock.

The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.

The bipartisan bill aims to provide federal support to children who are ill from an unknown cause and could gain insights into diagnosis or treatment approaches via WGS.