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Don’t Pass Up Chance to Steer LDTs, PAMA Reform

CLINICAL LABORATORY PROFESSIONALS HAVE RECEIVED A RARE CH…

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LDT Oversight May Fall to Congress, CLIA

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…

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May 12, 2025, Intelligence: Late-Breaking Lab News

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…

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With LDT Rule Vacated, Labs Await FDA Retort

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…

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Why Labs Should Comply with FDA’s Final Rule on LDTs

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…

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129,624 Genetic Tests in the United States

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

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Physicians Tempted by Lure of In-Office Labs, Payers Balk

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Assessing the Clinical Service & Revenue Issues of the LDT Rule

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

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Language in Draft House Bill Directs FDA to Suspend LDT Rule

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

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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