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Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

Day: July 1, 2020

FDA Announces First EUA for SARS-CoV-2 Testing Using Next-Generation Sequencing Technology

FDA maze of regulations

Where to start when working on a laboratory developed test using next generation sequencing (NGS) technology for diagnosing SARS-CoV-2, according to Timothy Stenzel, MD, PhD.

FDA Sends Warning Letters to Companies Improperly Marketing At-Home SARS-CoV-2 Antibody Tests

Models forming toward at-home testing for COVID-19.

At-home SARS-CoV-2 warning letters and implications for clinical laboratories and pathologists.

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