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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LDT Rule Is Now a Fact! What Will Be Consequences?

By R. Lewis Dark | From the Volume XXXI, No. 8 – June 10, 2024 Issue

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …

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ACLA Files Court Challenge to FDA’s Final LDT Rule

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s �…

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ACLA President Van Meter Discusses LDT Lawsuit

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…

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Attorneys Assess Impact of FDA’s Final LDT Rule

By Robert Michel | From the Volume XXXI, No. 8 – June 10, 2024 Issue

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and…

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Labcorp, Quest Issue Q1 Earnings, Offer Comments on FDA’s LDT Rule

By Robert Michel | From the Volume XXXI, No. 7 – May 20, 2024 Issue

  BOTH LABCORP, BURLINGTON, N.C., AND QUEST DIAGNOSTICS, SECAUCU…

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Labcorp, Quest Diagnostics Discuss Q4 & 2023 Earnings

By Robert Michel | From the Volume XXXI, No. 4 – March 18, 2024 Issue

DURING RECENT EARNINGS CALLS WITH FINANCIAL ANALYSTS AND INVESTORS, both Labcorp and Quest Diagnostics discussed their fourth quarter (Q4) and full year 2023 financial results. Each reported some stability in the market for clinical laboratory testing services, reflected in the numbe…

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Year’s Top 10 Lab Stories Contain Surprises & Twists

By Robert Michel | From the Volume XXX, Number 18 – December 26, 2023 Issue

CEO SUMMARY: With the SARS-CoV-2 pandemic now in the rearview mirror of the nation’s clinical labs and pathology groups, the important news stories of 2023 were mostly about developments where the consequences will influence laboratory operations in coming years. Artificial intelligence…

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