Coronavirus company news summary - Empowered Diagnostics submits updated EUA to FDA for rapid test - Purdue University researcher creates paper-based Covid test - Verdict Medical Devices
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Coronavirus company news summary – Empowered Diagnostics submits updated EUA to FDA for rapid test – Purdue University researcher creates paper-based Covid test

31 Aug 2021

AXIM Biotechnologies production partner Empowered Diagnostics has submitted a revised Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for ImmunoPass, AXIM’s rapid test to identify Covid-19 neutralising antibodies at point-of-care. The updated application says that the test results will be read as qualitative. In addition, the revisions comprise updated trials, BSL3 lab live virus comparisons, stability and control studies and the test’s robustness study.

PHASE Scientific has secured EUA from the Republic of Kenya’s Ministry of Health for the use of its INDICAID COVID-19 Rapid Antigen Test to detect the disease, in turn, enable early isolation, diagnosis and treatment. The lateral flow immunoassay qualitatively identifies SARS-CoV-2 antigens using nasal swab samples and delivers results in 20 minutes. Now available in 33 countries, INDICAID also holds EUA from the FDA and the European CE Mark.

A researcher at Purdue University has developed a quick and cost-effective paper-based Covid-19 test based on a biosensor technology used to identify Bovine Respiratory Disease (BRD) in cattle using nasal swabs. The new test, by agricultural and biological engineering assistant professor Mohit Verma, provides results in 60 minutes with an analytical specificity of 100%. Using saliva, the test can potentially check for different Covid-19 strains simultaneously.