TAG:
LDT rule
With LDT Rule Vacated, Labs Await FDA Retort
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
Identifying Current Lab Trends from Labcorp & Quest Experience
CEO SUMMARY: Many different factors influence the operations of clinical laboratories in the United States today. One good source of competitive business intelligence is for lab administrators to follow the quarterly earnings calls of the nation’s two biggest public lab corporations. Wi…
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
CURRENT ISSUE
Volume XXXII, No. 7 – May 12, 2025
Economic, Tech changes drive lab concerns, The Dark Report provides insights from the Executive War College speakers about how clinical labs can use business strategies and tactics to handle the new tariffs, future regulations, and artificial intelligence (AI). Also, this issue provides guidance on how labs and pathologists should prepare for payer audits.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
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