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 Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
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Genetic Testing Kickback Scheme Results in 46-Month Prison Term
Federal prosecutors continue to target situations where third-party recruiters influence test ordering
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Dx Deals: Labs Exploring Cryptocurrency Share Their Plans
Know Labs and ProPhase Laboratories discussed plans that in part involve digital currencies
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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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The Cost of Not Keeping Legacy Clinical Laboratory Technology Up to Date
By not modernizing legacy systems and software, labs risk incurring hidden costs
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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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