First looks and fast takes on LDT final rule
June 2024—The Food and Drug Administration’s final rule on laboratory-developed tests was released April 29 and published May 6. Shortly after, Compass Group laboratory leaders met online with CAP TODAY publisher Bob McGonnagle, who asked for their early reactions to what they heard and read. Among the categories for which the FDA has indicated its intent to exercise partial enforcement discretion are LDTs manufactured and performed by a laboratory that is integrated within a health system and that meet an unmet medical need. Here, this month, is the conversation that took place in early May. Next month we will publish our story on the final rule and the views of others. The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies.