The Dark Report Archives

For Lab Veterans, It’s Time to Step into AI’s Shadow

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

READING THROUGH THE FIRST INSTALLMENT OF THE DARK REPORT’S analysis about the state of artificial intelligence (AI) in clinical laboratories, this cantankerous observer found himself thinking about ChatGPT. Do I dare to use ChatGPT? Occasionally. Am I fluent in how to craft meaningful queries using Chat? No. Do I need to improve my game with […]

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Workers Use AI More than Lab Leaders Think

Clinical Laboratory Trends / Scott Wallask

CEO SUMMARY: In part one of an analysis about the state of AI in clinical laboratories, The Dark Report explores how frontline workers, especially younger ones, are using AI tools like ChatGPT far more than lab leaders. Recent reports elsewhere in the business world show executives underestimate staff AI use, raising concerns about a leadership

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Lab Industry Fallout from CLIAC Termination

Laboratory Compliance / Stephen Beale

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 delaying timely decisions about CLIA updates and closing off a popular forum to

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AMP Reports Provide Crucial Insights for Hiring Managers

Laboratory Management / Kristin Althea O’Connor

IN AN EXCLUSIVE INTERVIEW WITH THE DART REPORT, Somak Roy, MD, chair of AMP’s Clinical Bioinformatician Body of Knowledge Steering Committee, shared best practices that hiring managers at clinical molecular diagnostic laboratories can use to ascertain which candidates could be a long-term fit for the lab. Roy’s insights follow the publication of an Association for

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Regional Health Systems Are New Dominant Players in M&A

Laboratory Management / Scott Wallask

READERS OF THE DARK REPORT UNDERSTAND HOW INTERTWINED THEIR CLINICAL LAB BUSINESS is with healthcare system mergers and acquisitions (M&A). Thus, financial service firm Morgan Stanley’s recent report on M&A activity in the healthcare industry will be of interest from a laboratory perspective. The report, “Healthcare M&A Trends Reshaping US Health Systems,” reveals a profound

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Regeneron Loses 23andMe Bid to TTAM Research Institute

Genetic Testing / Jillia Schlingman

23andMe FOUNDER AND FORMER CEO ANNE WOJCICKI has successfully retained control over her company by selling it to her nonprofit medical research firm TTAM Research Institute for $305 million. This followed bidding between TTAM Research Institute and Regeneron Pharmaceuticals, which previously announced it had entered into a purchasing agreement to acquire most of the assets

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News Briefs on Alzheimer’s Detection

Clinical Laboratory Trends / Scott Wallask

FDA-cleared IVD could replace scans There has been a significant amount of activity in recent weeks as it concerns tests to detect Alzheimer’s disease. Clinical labs and neuropathologists will want to keep a close eye on Alzheimer’s-related progress throughout the rest of 2025. Perhaps most significantly, Fujirebio made headlines with the Food and Drug Administration’s

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June 23, 2025, Intelligence: Late-Breaking Lab News

Late Breaking Lab News / Scott Wallask

Clinical labs that have business in clinical trials involving genetic samples should note that on June 18, the Food and Drug Administration (FDA) ordered a review of new trials that send samples to “hostile countries for genetic engineering.” The FDA mentioned China specifically. The agency said it wants to stop China and other countries at

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How Medicaid Cuts May Affect Clinical Labs

Lab Intelligence, Laboratory Management, The Dark Report / Mark Terry

CEO Summary: As lawmakers debate the merits of President Donald Trump’s budget bill, it appears that Medicaid changes are on the horizon. For medical laboratories, three immediate areas to monitor include potentially decreased Medicaid recipients, federal cuts to Medicaid funding, and changes to cost sharing for individuals. This trio of factors could dent lab reimbursement

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Others Want Diagnostic Data, Labs Should Too

Commentary and Opinion by R. Lewis Dark, Laboratory Compliance / R. Lewis Dark

ONE NEED NOT LOOK FURTHER THAN THE PAGES OF THIS ISSUE OF THE DARK REPORT to once again realize the importance of the diagnostic data residing within your clinical laboratory operations. Perhaps it’s rote to say “diagnostic data is a gold mine” for labs. But if all labs truly acted on that notion, wouldn’t everyone

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