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LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision

LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision

by Scott Wallask | Apr 29, 2025 | CLIA-lca, Enforcement-lca, Enforcement-lir, Enforcement-nir, Essential, FDA-lir, FDA-nir, Lab Industry Advisor, LDTs-lir

Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes

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LDT Oversight Remains Under CLIA, for Now

LDT Oversight Remains Under CLIA, for Now

by Scott Wallask | Apr 4, 2025 | CLIA-nir, CMS-nir, Compliance-nir, Enforcement-nir, Essential, FDA-lca, FDA-lir, FDA-nir, Lab Industry Advisor, LDTs-lir

Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests

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FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say

FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say

by Ron Shinkman | Mar 28, 2025 | Essential, FDA-lca, Lab Industry Advisor

Pre-submission and Q-Submission meetings apparently have been halted, for now

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Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously

Diagnostics Pipeline: Roche’s New Cobas Liat Panel Can Test for Multiple STIs Simultaneously

by Ron Shinkman | Mar 11, 2025 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet

The PCR-driven test provides results in about 20 minutes in non-laboratory settings

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MeMed Sepsis Test Gains Breakthrough Device Designation

MeMed Sepsis Test Gains Breakthrough Device Designation

by Ron Shinkman | Jan 31, 2025 | Essential, FDA-lca, Lab Industry Advisor

The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026

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