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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Several Times, Feds Tried to ‘Redirect’ Lab Activities

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

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b…

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Artificial Intelligence and Executive War College

By R. Lewis Dark | From the Volume XXXI, No. 6 – April 29, 2024 Issue

By the time you read this our 29th annual Executive W…

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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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Labs Should Prepare for Arrival of ‘Perfect Storm’

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

CEO SUMMARY: In the near future, clinical labs and pathology groups will need to address three major developments. One involves the FDA proposed LDT rule. A second is the adoption by payers of guidelines that require genetic test claims to have Z-Codes. The third centers around coming ref…

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CMS Issues AI Guidance for Medicare Advantage

By Mary Van Doren | From the Volume XXXI, No. 3 – February 26, 2024 Issue

CEO SUMMARY: With its guidance on how Medicare Advantage plans should use artificial intelligence (AI) when making treatment decisions involving individual patients, the federal Centers for Medicare and Medicaid Services has opened one door in the coming debate on how the federal governme…

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February 26, 2024, Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 3 – February 26, 2024 Issue

Following an investment of $1.75 million, officials at University of Maine at Augusta (UMA) opened a new lab facility this month that allows it to double the number of medical laboratory technicians it can train, from eight to 10 to as many as 20. In its coverage of the new training …

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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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CLIA Lab Directors Must Watch Delegated Duties

By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue

CEO SUMMARY: Laboratory accredito…

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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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