Laboratory-developed tests (LDTs) are transforming patient care for rare diseases and emerging health challenges by offering tailored diagnostics when commercial tests may not be feasible. Following the recent judicial decision to vacate the FDA's LDT Final Rule, laboratories now operate under CLIA, promoting innovative development that addresses specific community needs. By leveraging resources, partnerships, and modern technologies, labs can deliver effective testing solutions while also working to enhance access and ensure quality standards, ultimately improving healthcare outcomes.
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