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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What if Congress Chooses to Pass an LDT-Specific Law?

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

CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test…

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How Private Health Insurers May Respond to FDA LDT Regulation

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

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Congressional Subcommittee Hears Testimony on FDA LDT Rule

By Robert Michel | From the Volume XXXI, No. 6 – April 29, 2024 Issue

DURING A MARCH 21 HEARING CONVENED by the U.S. House Energy and Commerce Subcommitt…

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FDA Issues Memo to Reclassify Many High Risk IVD Assays

By Robert Michel | From the Volume XXXI, No. 5 – April 8, 2024 Issue

WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…

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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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FDA & CMS Issue Letter, Agree on LDT Oversight

By Robert Michel | From the Volume XXXI, No. 2 – February 5, 2024 Issue

CEO SUMMARY: With the release of a public statement about the oversight of LDTs on Jan. 24, 2024, officials at both the Food and Drug Adminstration and the Centers for Medicare and Medicaid Service went on record that both agencies are aligned in the spec…

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2024: Year of Decision for FDA Regulation of LDTs

By R. Lewis Dark | From the Volume XXX, Number 18 – December 26, 2023 Issue

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION…

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Two Forces Push for More FDA Oversight of LDTs

By R. Lewis Dark | From the Volume XXX, No. 14 – October 2, 2023 Issue

CLINICAL AND GENETIC TESTING LABS MAY SUDDENLY FEEL THEMSELVES STUCK IN THE MIDDLE of a yin-yang situation when it comes to laboratory developed tests (LDTs). One force, the U.S. Food and Drug Administrati…

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FDA’s Road to Regulation of Lab Developed Tests

By Robert Michel | From the Volume XXX, No. 14 – October 2, 2023 Issue

CEO SUMMARY: Today’s generation of clinical lab managers and pathologists should understand that the FDA’s efforts to publish a draft rule defining its authority to review laboratory developed tests (LD…

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