Red Flags in Clinical Lab Operations Rise from Recent Court Cases
Guilty plea points to patient data collection, while settlement implicates an undisclosed relationship
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Articles and Reports
FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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Dx Deals: Danaher Acquires StatLab in Deal Valued at More than $1 Billion
The company will fold into Leica Biosystems after the transaction closes at the end of this year
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FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
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Dx Deals: Labcorp Continues Dealmaking with Incyte Asset Acquisition in Washington State
The majority of Labcorp’s revenue growth in the first quarter came from clinical lab acquisitions
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Brief AI Glossary Can Help Clinical Lab Managers Navigate a Litany of Terms
We explain what ‘tokens’ are, as well as what ‘GPT’ really means
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Why Revenue Cycle Management Systems Fall Behind—and How to Modernize Them
Clinical lab billing teams face an overwhelming number of challenges if revenue cycle strategies fall short
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Clinical Lab Data Protection Measures Help Guide University of Pittsburgh Medical Center
UPMC pathology leader discusses steps the lab takes to combat evolving cyber threats
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Lawyers Give Their Tips to Spot Clinical Lab Fraud
Medical laboratories should monitor fraud cases across the country and also stay vigilant of suspicious patterns of behavior
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Dx Deals: Labcorp and BioReference Health Agree on $225m Sale of Some Assets
Labcorp will acquire oncology-related clinical tests services from BioReference’s parent company, OPKO Health
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Heed AKS and EKRA to Properly Market Clinical Lab Services
Read this overview of legislation and regulations governing laboratory marketing practices and learn tips to ensure these activities remain compliant
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New CLIA e-Notifications: Here’s What Clinical Labs Need to Know
As of March 1, 2026, CMS will move CLIA away from paper-based transactions to improve efficiency and payments
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