FDA Announces First EUA for SARS-CoV-2 Testing Using Next-Generation Sequencing Technology
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
At-home SARS-CoV-2 warning letters and implications for clinical laboratories and pathologists.