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LDT rule
Identifying Current Lab Trends from Labcorp & Quest Experience
By Robert Michel | From the Volume XXXI, No. 11 – August 12, 2024 Issue
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
By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue
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 XXXI, No. 14 – October 14, 2024
For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Also, several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exome, whole genome sequencing, and rapid whole genome sequencing can deliver both improved patient outcomes and a return on investment.
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