TAG:
ldt
Using AI to Predict Outcomes in FDA LDT Lawsuits
Given the popular sentiment that artificial intelligence (A…
Top 10 Lab Stories for 2024 Reflect Important Trends
CEO SUMMARY: Most clinical laboratory managers will agree that the Food and Drug Administration’s (FDA) final rule to regulate laboratory developed tests (LDTs) is the biggest lab industry story for 2024. Every laboratory performing LDTs must now devote money and time to comply with the…
129,624 Genetic Tests in the United States
REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…
Two Different LDT Lawsuits Combined in Federal Court
CEO SUMMARY: Different lawsuits challenging the FDA’s LDT rule were filed in recent months by the American Clinical Laboratory Association and the Association for Molecular Pathology. Both lawsuits were filed in the U.S. District Court for the Southern …
Hurdles Continue When Labs Request Genetic Test Coverage
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Assessing the Clinical Service & Revenue Issues of the LDT Rule
BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…
Unpacking the Surprises in the FDA LDT Rule
THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…
September 3, 2024, Intelligence: Late-Breaking Lab News
To challenge the federal Food and Drug Administration (FDA) final rule on laboratory developed tests (LDTs,) the Association for Molecular Pathology (AMP) filed a lawsuit on August 20, 2024, in the United States District Court for the Southern District of Tex…
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’s a Big Headwind for Labs? It’s the LDT Rule!
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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.
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