TAG:

laboratory-developed test

FDA Replaces March 16 Serology COVID-19 Rules

CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the la…

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Chicago Lab Launches LDT, Finds 20% Positive

CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…

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