The Dark Report Archives

Regeneron Loses 23andMe Bid to TTAM Research Institute

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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Federal Court Reverses Conviction in AKS Case

Laboratory Compliance / Stephen Beale

CEO SUMMARY: A federal appeals court has overturned the conviction of an operator of a durable medical equipment company who was accused of violating the Anti-Kickback Statute. A marketing company’s lack of true influence over decision-making related to the case seemed to sway the court. For clinical laboratory owners, the distinction is subtle and may

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UnitedHealth Group Heads into Difficult Waters Mid-Year

Laboratory Management / Scott Wallask

WITH THE NEWS THAT THE FORMER HEAD OF UNITEDHEALTH GROUP (UHG) has returned after the sudden resignation of the company’s CEO, it is apparent that pressure on the healthcare company continues to mount. This latest twist comes on top of a bad past 18 months for the company, a period which included a massive cyberattack,

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Labs Beware: ‘Vishing’ Rises as Major Cybersecurity Threat

Laboratory Management / Stephen Beale

CYBERSECURITY SHOULD ALWAYS BE TOP OF MIND FOR CLINICAL LABORATORIES AND PATHLOGY groups, especially since the notorious data breach at Change Healthcare in February 2024. Often, such security breaches begin with phishing campaigns in which employees are enticed to click on malicious links in emails or social media messages. But these days, labs should also

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Epic Gains EHR Market Share as Oracle Loses Ground

Laboratory Information Systems / Stephen Beale

EPIC SYSTEMS, THE DOMINANT VENDOR OF ELECTRONIC HEALTH RECORDS (EHR) SOFTWARE, expanded its market share in 2024, gaining a net 176 hospitals and 29,399 beds. That’s according to KLAS Research, which based its data on interviews with hospitals as well as other sources, including the vendors themselves. This was Epic’s “largest net gain on record,”

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Leveraging Data to Create Lab and Healthcare Efficiencies

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: In this exclusive interview with The Dark Report, Bradley Bostic, founder, chair, and CEO of healthcare and laboratory data intelligence company hc1 discusses trends in healthcare, how to position clinical laboratories as a strategic asset, and ways to analyze diagnostic data to improve efficiency and increase the bottom line. A key point Bostic

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