TAG:
clia
Don’t Pass Up Chance to Steer LDTs, PAMA Reform
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…
LDT Oversight May Fall to Congress, CLIA
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…
May 12, 2025, Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue
Yet another clinical laboratory has sold off part of its services to a national commercial lab. Labcorp announced on April 21 that it had finalized its acquisition of North Mississippi Health Services’ (NMHS) ambulatory outreach laboratory business. A…
With LDT Rule Vacated, Labs Await FDA Retort
By Robert Michel | From the Volume XXXII, No. 6 – April 21, 2025 Issue
CEO SUMMARY: In a major win for clinical laboratories, a federal judge vacated the FDA’s final rule on LDTs, writing in his decision that the agency overstepped its authority. For now, labs can develop and modify LDTs without FDA oversight, but future action in some form…
Why Labs Should Comply with FDA’s Final Rule on LDTs
By Robert Michel | From the Volume XXXII, No. 3 – February 17, 2025 Issue
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
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…
Physicians Tempted by Lure of In-Office Labs, Payers Balk
By Virchow | From the Volume XXXI, No. 14 – October 14, 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…
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…
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…
CURRENT ISSUE

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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