The LDT Landscape: Navigating Regulatory Shifts and LIS Requirements
In today’s rapidly evolving diagnostic landscape, labs are under immense pressure to provide results that are both immediate and reliable. This has created a fundamental conundrum: should labs be empowered to create their own tests to meet urgent patient needs, or is the rigorous—and often time-consuming—process of FDA review a non-negotiable necessity for safety? To […]
