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What’s a Big Headwind for Labs? It’s the LDT Rule!
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Rural Hospital Lab Hits Automation Home Run
CEO SUMMARY: With the hospital adding specialist physicians and at the same time enjoying sustained growth in outreach test volume, the lab was hit with the dual need to expand the in-house test menu and reconfigure workflow to handle predictions of ongoing growth in outreach testin…
New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings
CEO SUMMARY: Our second installment in this series describes an emerging new clas…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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