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Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits

by Glenn S. Demby | Jan 19, 2023 | Essential, FDA-nir, National Lab Reporter

At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.

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North American Leaders Commit to Better Pandemic Preparedness

North American Leaders Commit to Better Pandemic Preparedness

by Rachel Muenz | Jan 18, 2023 | News, Open Content

The recent Declaration of North America makes updating the current North American Plan for Animal and Pandemic Influenza a priority.

Recent Discovery Could Lead to a Better Lyme Disease Test

by Glenn S. Demby | Dec 21, 2022 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Special Focus-dtet

Researchers have identified 35 genes found in high expression in people with long-term Lyme disease, which could lead to earlier detection.

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FDA Revises EUAs for COVID-19 Antigen Tests

FDA Revises EUAs for COVID-19 Antigen Tests

by Rachel Muenz | Nov 2, 2022 | News, Open Content

In response to the latest data on repeat testing, on Nov. 1, the agency made a few changes to EUAs for such tests.

ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort

ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort

by Glenn S. Demby | Oct 19, 2022 | News, Open Content

Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.

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