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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HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
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Reporting Noncompliance in Clinical Labs Requires the Right Channels and Culture
A lawyer advises medical laboratories on how to improve their avenues for reporting unethical behavior
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FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
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Possible Job Description for a Diagnostic Health Consultant
The role at this point is theoretical, but our editors asked AI for help in drafting what the position might entail
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Diagnostic Health Consultant: A New Role Proposed for the Clinical Laboratory
While still in the early stages, Clinical Lab 2.0’s pitch for this new position fits with the need to better use lab data
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No Signs of the DOJ Letting Off the Pedal with Medicare Fraud Investigations
However, a new memo instructs federal prosecutors to ‘avoid overreach’ when parties cooperate with authorities
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Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
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Dx Deals: Quest Diagnostics M&A Centers on Precision-Focused Approach
Recent inroads into testing of water for dialysis equipment illustrates Quest’s expanded scope with deals
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Interconnected Clinical Lab Devices Can Increase Operational Capabilities
However, integrated technologies must take into account data protection concerns
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LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
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