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More Signs of Shifting Sands in the Lab World

If you feel like the ground is shifting under y…

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CAP Regains VA Lab Accreditation Contract

CEO SUMMARY: In a blow to The Joint Commission, the US Department of Veterans Affairs has awarded a new clinical laboratory accreditation contract to the College of American Pathologists (CAP). The decision highlights the competition between the two accrediting organizatio…

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Accreditors Explain Changes to CLIA Supervisor Qualifications

In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussio…

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October 27, 2025, Intelligence: Late-Breaking Lab News

In yet another shuffling of the in vitro diagnostics (IVD) space, Hologic announced on Oct. 21 that it was being acquired by private equity firms Blackstone and TPG for $18.3 billion. The deal will take Hologic off the Nasdaq, likely in early 2026. TPG and Blackstone lauded Hol…

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August 25, 2025, Intelligence: Late-Breaking Lab News

As we first reported in Dark Daily earlier this month, several states have taken initiative to regulate how artificial intelligence (AI) applies to clinical laboratory services. For example, a California law that went into effect earlier this year impacts providers who use gene…

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Lab Industry Fallout from CLIAC Termination

CEO SUMMARY: Some diagnostic lab leaders and anatomic pathology practice owners may not immediately think that the elimination of a federal advisory panel should be on their radar. But the demise of the Clinical Laboratory Improvement Advisory Committee may cost labs by de…

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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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Negotiating Path Contracts with Hospitals, Third Parties

PART THREE OF A SERIES TO HELP ANATOMIC PATHOLOGY GROUPS THRIVE AND PROSPER during these challenging times, The Dark Report presents this third installment in a series that identifies clinical, operational, and financial strategies pathology groups…

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Pathologist Frederick Kiechle, MD, Molecular Pioneer, Dies at 78

Clinical pathology lost one of its greatest practitioners when pathologist Frederick L. Kiechle, MD, PhD, FCAP, of Cooper City, Fla., died on July 30, 2024, at the age of 78. …

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October 14, 2024, Intelligence: Late-Breaking Lab News

Babson Diagnostics of Austin, Texas, received a “strategic investment” from Becton, Dickinson and Company (BD). The amount of the investment was not disclosed. In the past year, Babson launched an innovative lab testing service with retail pharmacies in Austin an…

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