SensNews March 2020

Sensor100 Page 7 Thermo Fisher ships coronavirus tests, aims to produce 5 million tests a week by April. Thermo Fisher’s coronavirus test, an instrument called Applied Biosystems 7500 Fast Dx Real-time PCR, has not been FDA approved, though the EUA permits its use to diagnose the novel virus in patients. CNBC 16 March | Genome Web 26 March Roche announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the cobas® SARS-CoV-2 Test. It is intend- ed for the qualitative detection of SARS- CoV-2, the virus that causes COVID-19 disease, in nasopharyngeal and oropharyn- geal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and around the world.The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affect- ed areas where the SARS-CoV-2 virus is known to be present. Roche Press Release 16 March Diagnosing COVID-19 using AI-based medical image analyses Quantib Blog 20 March SureScreen’s COVID-19 rapid test identifies the body’s response to coronavirus after the onset of infection, and gives a qualitative yes/no result within 10 minutes. The blood sample test is CE marked and is based on lateral flow. It identifies both IgG and IgM bio- markers. SureScreen Diagnostics The Spanish health ministry said some 9,000 rapid diagnostic tests imported from China had proved defective.Their use has been suspended, it said. The Chinese firm has offered to replace the test kits and provide more informa- tion on how they should be used. VOA News 28 March