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Two commercial labs testing now for COVID-19

Two commercial labs testing now for COVID-19

by Glenn S. Demby | Mar 8, 2020 | Articles, CDC-nir, CMS-lir, CMS-nir, Essential, FDA-lir, FDA-nir, Laboratory Industry Report

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FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test

FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test

by Glenn S. Demby | Mar 2, 2020 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, Emerging Tests-dtet, FDA-dtet, Laboratory Industry Report

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Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests

Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests

by Glenn S. Demby | Feb 25, 2020 | FDA-nir

The 2019 novel Wuhan coronavirus outbreak caught regulators and diagnostic test makers off guard. As the death toll mounts, the scramble is on to develop tests capable of detecting the virus. Here’s a rundown of what the FDA is doing to achieve that objective. The...
Special Report: FDA to Use EUA Pathway to Clear New Coronavirus Tests

Lab Companies Scramble to Bring Coronavirus Detection Tests to Market

by Glenn S. Demby | Jan 30, 2020 | Articles, CDC-nir, Clinical Diagnostics Insider, CMS-lca, Diagnostic Testing and Emerging Technologies, FDA-dtet, FDA-lca, FDA-lir, Industry Buzz-lir, Lab Compliance Advisor, Laboratory Industry Report, Top of the News-dtet

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After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules

by Glenn S. Demby | Feb 22, 2019 | CLIA-lca, Essential, Lab Compliance Advisor

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