Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

This first table includes information about authorized SARS-CoV-2 molecular diagnostic tests. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. (Source: FDA.gov) Visit our Lab Resource Center. Date EUA Issued or Last UpdatedEntityDiagnostic (Most Recent Letter of Authorization) and Date EUA Original IssueAttributesAuthorized Setting(s)Authorization Documents 10/13/2020Thermo Fisher Scientific,...

Frost & Sullivan Report Identifies Molecular Diagnostics as Fastest-Growing Sector of Clinical Pathology Laboratory Testing

Annual growth rates of 11% or more is predicted for molecular diagnostics in coming years Just as consolidation and acquisitions reshaped the in vitro diagnostics (IVD) manufacturing industry and concentrated market share among just a handful of multi-billion dollar IVD giants, a similar consolidation can be seen in the molecular diagnostics sector. Today it is estimated that just nine global companies control 75% of the molecular diagnostics market. That market concentration means clinical...
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