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FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?

FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?

by Ron Shinkman | Sep 5, 2024 | Essential, FDA-lca, Lab Industry Advisor

The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test

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FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?

FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?

by Ron Shinkman | Jul 24, 2024 | Essential, FDA-lca, Lab Industry Advisor, LDTs-lir

A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes

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FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months

FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months

by Ron Shinkman | May 27, 2024 | Compliance-lca, Essential, FDA-lir, Lab Industry Advisor

Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests

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FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization

FDA Watch: AI-Based Sepsis Prediction Test Receives FDA Authorization

by Ron Shinkman | May 1, 2024 | Essential, FDA-lir, Lab Industry Advisor

Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization

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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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