CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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Dx Deals: Veracyte Acquires Convergent Genomics for up to $180 Million
The deal gives the oncology-focused Veracyte a boost in bladder cancer detection
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What New Prior Authorization Metrics Mean for Clinical Labs
KFF looks into payer claims denials, which continue to be scrutinized
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Dx Deals: Profusa Trying to Buy G3 Vision Labs in Unusual $455 Million Stock Deal
If Profusa pulls off the purchase, it will give the startup its first revenue source
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FDA Watch: Labcorp Gets Companion Diagnostic Approval for Advanced Melanoma Test
Company also announces distribution of newly approved Alzheimer’s assay
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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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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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Software as a Medical Service, or SaMS, Takes Spotlight in New CMS Proposal
Clinical labs have until Aug. 31 to submit public comments about the anticipated changes
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Six RCM Tips from the ADLM 2026 Meeting
Watch for panel unbundling, Medicare spending shifts, and frequency-based denials
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Lessons in Laboratory Compliance from a $30 Million Settlement
‘Lean lab’ setup appears to have caught the eyes of investigators
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Dx Deals: Labcorp Quietly Buys Tribal Diagnostics
Acquisition likely isn’t a full-blown push into Native American healthcare, consultant Larry Worden says
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