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The coalition includes partners from all over the world, including universities, research centers, and health systems in South Asia, Africa, South America, and the US.
With $10 billion in federal funding supporting school screening, labs, vendors, and various other institutions are ramping up efforts to roll out K-12 testing programs.
The latest US Food and Drug Administration Emergency Use Authorizations allow the tests to be used for serial testing in asymptomatic individuals.
The eight-month contract is for Abbott to provide 50 million BinaxNow SARS-CoV-2 antigen tests with the ordering period ending on Oct. 31.
The program will identify new pathogens, analyze potential risk level, develop and deploy new diagnostic testing, and assess the public health impact.
The company also said that a previously granted EUA for its Alinity m SARS-CoV-2 assay has been expanded to include asymptomatic individuals and pooled testing.
FDA has signaled via public comments that it is flexible on test performance specs, but firms remain wary of falling short of official agency requirements.
News items for the in vitro diagnostics industry for the week of March 1, 2021.
The test detects IgG antibodies in human serum and plasma and is intended to help identify people with an adaptive immune response to the virus.
The findings stem from a recent meeting of a WHO Guideline Development Group convened to address challenges with TB diagnosis and related drug-resistance.