129,624 Genetic Tests in the United States

By R. Lewis Dark | From the Volume XXXI, No. 16 – November 25, 2024 Issue

REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) by the federal Food and Drug Administratio…

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Two Different LDT Lawsuits Combined in Federal Court

By Robert Michel | From the Volume XXXI, No. 16 – November 25, 2024 Issue

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 …

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Hurdles Continue When Labs Request Genetic Test Coverage

By Virchow | From the Volume XXXI, No. 13 – September 23, 2024 Issue

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Assessing the Clinical Service & Revenue Issues of the LDT Rule

By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue

BARRING INTERVENTION BY FEDERAL COURTS OR THE U.S. Congress, clinical labo…

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Unpacking the Surprises in the FDA LDT Rule

By R. Lewis Dark | From the Volume XXXI, No. 12 – September 3, 2024 Issue

THERE ARE NOW TWO LAWSUITS IN TWO DIFFERENT COURTS CHALL…

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September 3, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 12 – September 3, 2024 Issue

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…

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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…

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What’s a Big Headwind for Labs? It’s the LDT Rule!

By R. Lewis Dark | From the Volume XXXI, No. 10 – July 22, 2024 Issue

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Language in Draft House Bill Directs FDA to Suspend LDT Rule

By Robert Michel | From the Volume XXXI, No. 10 – July 22, 2024 Issue

THERE IS AN INTERESTING NEW DEVELOPMENT associated with the regulation of laboratory deve…

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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…

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