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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Beyond the News: What Does Latest ACA Court Ruling Really Mean?
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Scorecard: OIG Enforcement Actions against Labs in 2019
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FDA Resounds the Alarm on Biotin Test Interference
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Genetic Testing: CMS Proposes Expanding NGS Testing Eligibility
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CLIA: CMS Revises State Operations Manual for Labs
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Hospital Labs: CMS Pushes Forward with Controversial Price Transparency Rules
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The Year in Labs Regulation: The 6 Biggest Stories of 2019
"May you live...
Diagnostic Deals: Illumina/PacBio Merger Derails & Qiagen Takes Itself Out of Play
As 2019 came to a close, the biggest story in DX deal making was the pair of anticipated M&A deals that suddenly seem unlikely to happen. As a result, two major genetic testing companies will apparently continue as stand-alones in the coming year, one because it wants to and the other because it has to.
Alabama Doctors, Cardio Practice, Settle Genetic Testing Kickback Claims for $1.1 Million
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