FDA Updates Templates for Serology Test EUA Requests
The updates clarify FDA’s previous recommendations for demonstrating clinical performance and presenting validation data and provide new recommendations.
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Active Motif Announces Report on Recombinant Human Covid-19 Antibodies
The SARS-CoV-2 antibodies are being sourced by diagnostic developers for applications such as lateral flow assays and ELISAs.
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First Open Source All-Atom Models of Full-Length Covid-19 ‘S’ Protein
The model-building program is open access and can be found from the home page of Charmm-GUI, a program that simulates complex biomolecular systems.
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Applied BioCode SARS-CoV-2 Assay Granted FDA EUA
The nucleic acid assay is for the qualitative detection of SARS-CoV-2 nucleic acids in respiratory samples from individuals who are suspected of covid-19.
Read MoreFDA Warning Letters to Companies Inappropriately Marketing Antibody Tests
The action is an effort to help protect public health from fraudulent products.
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