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The Dark Report

Top Stories in 2025 Played Out in Courts, Capitol Hill

Clinical Laboratory Trends /

CEO SUMMARY: The biggest story of the year for clinical laboratories came in a huge court victory, as a federal judge vacated the FDA’s final rule on laboratory developed tests. Labs breathed a sigh of relief after the court decision, as the FDA rule had promised to increase regulatory scrutiny and costs for organizations creating […]

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Strategies to Succeed with Laboratory Outreach Programs

Laboratory Management /

In recent years Labcorp and Quest Diagnostics went on buying sprees, acquiring laboratory outreach businesses from major health systems. They argue that they can run these operations more efficiently, while the sellers get much-needed cash infusions. (See “Hospital Lab Outreach: Still a Valuable Asset,” Sept. 23, 2024.) But these deals could prove to be misguided

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In 2026, Challenges Can Be Business Opportunities

Commentary and Opinion by R. Lewis Dark /

Looking over The Dark Report’s annual rundown of the most significant clinical laboratory and pathology stories of the past year, the world “tumult” comes to mind. At points during the past year the tumult leaned in the favor of labs, such as a federal judge vacating the Food and Drug Administration’s rule on laboratory developed

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One Lab’s Solution to Its Histotechnologist Shortage

Laboratory Management /

Histology workforce shortages remain one of the major challenges within the clinical laboratory industry, and, unfortunately, as the demand for histotechnologists increases, the number of qualified personnel has been decreasing. A report released in September by the American Society for Clinical Pathology (ASCP) revealed the total vacancy rate for histology was 20.5% in 2024. This

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Redefining Path Reports to Be Patient’s Partner

Anatomic Pathology /

CEO SUMMARY: The 21st Century Cures Act gave patients immediate access to their pathology report results, prompting pathologists to rethink their role. New research indicates that patients often see their pathology results before their physicians do, creating a gap in context that pathologists can help fill. Patient-centered reporting enhances understanding, engagement, and overall care outcomes.

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December 29, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News /

The US Department of Veterans Affairs (VA) is expanding its use of precision medicine through a new multi-year contract with Baylor Genetics to provide pharmacogenomic (PGx) and germline genetic testing to veterans across the VA’s nationwide healthcare system. The agreement includes PGx testing as well as hereditary cancer analysis, supporting broader genomic integration within federal

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Paper, the Cloud, and Lessons for Laboratories

Commentary and Opinion by R. Lewis Dark /

Paper requisitions. Cloud-based data. These two concepts are on opposite ends of the spectrum in clinical labs and pathology practices. Paper is an old-school institution that some labs continue to use. How many draw stations still require patients to fill out a hardcopy form and then immediately place it in a basket for a phlebotomist

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Labs Enter a Critical PAMA Reform Window

Laboratory Billing /

CEO SUMMARY: A reprieve of upcoming PAMA cuts to lab test reimbursement rates is official with an extension through Jan. 30, 2026. This, however, is not a lot of time and pressure is on the clinical laboratory industry to get the RESULTS Act passed to permanently reform PAMA. Lab industry advocates are urging individual diagnostic

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Pathologists Take Images to the Cloud

Digital Pathology /

CEO SUMMARY: Scaled-up operations, streamlined logistics, and potential cybersecurity benefits all present a valid argument for pathology practices to move their data to the cloud. Digital pathology in particular stands to gain from a cloud-based setup that allows remote viewing of cases and better integration of AI-related features. Despite the advantages, cloud adoption remains sluggish

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Abbott Bets Hard on Cancer Diagnostics with New Deal

In Vitro Diagnostics /

Abbott Laboratories’ deal to acquire Exact Sciences for $23 billion emphasizes the value that the in vitro diagnostics (IVD) manufacturer puts on cancer testing. Clinical laboratories involved with oncology should monitor the progress of this deal and whether other IVD companies pursue similar endeavors, said Larry Worden, principal at research and consulting firm IVD Logix.

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