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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Laboratory Industry Report
Keeps You Up-to-Date on Lab Business and Competitive Strategy, Market Trends and Opportunities, and M&A and Investment Activity in Today’s Diagnostic Lab Industry
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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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Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
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Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS’ proposal
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FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
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Dx Deals: Labcorp and Roche Enter into Pacts to Distribute Alzheimer’s Tests, Digitize Slides
The technology developed by Roche in recent years seems a good fit for Labcorp’s testing services
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Clinical Lab Training Documentation Becomes More Important with CMS Revision
Third-party verification of lab personnel experience is now a CLIA requirement
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PAMA Cuts to Clinical Labs Get Brief Delay Through January 30, 2026
Bill that ended government shutdown includes provision to hold off PAMA cuts
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2026 Predictions for Clinical Labs: AI, Audits, and Increased Enforcement
How clinical laboratories should prepare for the next wave of oversight in the new year
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Dx Deals: Sonic Healthcare Buys East Coast Lab in First Such US Acquisition Since 2021
Australian firm has grown its overseas operations dramatically in the past decade, except in America
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Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
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FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
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