The complaint emphasizes how much of an economic burden this new rule could place on laboratories. For example, FDA estimates cited by AMP see initial compliance costs totaling up $114 billion with annual costs of $14.31 billion additional. AMP argued that these projections underestimated the true costs, especially for smaller labs serving a rural or disadvantaged community area, which might have difficulty achieving regulatory compliance.
The group also warned that the rule could stifle innovation and harm patients if smaller labs were forced to close or consolidate, limiting access to diagnostic testing in underserved areas. The lawsuit claims that “patients would pay the ultimate price,” as certain diseases could go undiagnosed due to fewer available testing options.
However, FDA Commissioner Robert Califf supported the move, saying that as the use of LDTs increases it’s important for people to have confidence that if they are using these tests at all their results will be accurate and reliable.
