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FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection

FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection

by Ron Shinkman | Mar 28, 2024 | Essential, FDA-lca, Lab Industry Advisor

The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan

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Year in Review: The 8 Most Important Lab Compliance Stories of 2023

Year in Review: The 8 Most Important Lab Compliance Stories of 2023

by Glenn S. Demby | Jan 9, 2024 | Elite, Inside the Lab Industry-lir, Lab Industry Advisor

Though things appeared status quo in 2023, last year may prove to be a turning point for the laboratory industry.

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The Future of Laboratory-Developed Tests

The Future of Laboratory-Developed Tests

by Michael Schubert, PhD | Jan 2, 2024 | Essential, FDA-lca, Lab Industry Advisor, LDTs-lir, Legislation-lca

Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.

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FDA’s LDT Proposal Raises Questions About Clinical Validity

FDA’s LDT Proposal Raises Questions About Clinical Validity

by Scott Wallask | Nov 22, 2023 | Clinical Diagnostics Insider, FDA-dtet

Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.

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FDA Proposal for LDTs Risks Serious Consequences

FDA Proposal for LDTs Risks Serious Consequences

by Gail Dutton | Oct 18, 2023 | Essential, FDA-lir, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

Lab leaders say that the increased level of scrutiny proposed for such tests would be a detriment to innovation and patient care.

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