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.
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.
