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October 21, 2021

Coronavirus company news summary – Sorrento’s Covid-19 rapid antigen test obtains CE mark – India grants emergency approval to LumiraDx’s Covid-19 antigen test

By Chloe Kent

Sorrento Therapeutics has obtained a CE mark for its rapid Covid-19 diagnostic test COVISTIX. The test is designed to identify the SARS-CoV-2 nucleocapsid antigen in nasal or nasopharyngeal samples. COVISTIX can reportedly deliver results in nearly 15 minutes with a sensitivity of 81%. The test has received Emergency Use Authorization (EUA) in Mexico while EUA filings are progressing in the US, Canada, Brazil and with World Health Organization (WHO).

India’s Central Drugs Standard Control Organisation has granted emergency use approval to LumiraDx’s SARS-CoV-2 Antigen test. Designed to identify antigen nucleocapsid protein of SARS-CoV-2 virus from a nasal swab sample, the test provides results in less than 12 minutes from sample application. In clinical trials, the test was found to have a 97.6% positive agreement and 96.6% negative agreement in individuals within the initial twelve days of the first onset of symptoms. LumiraDx SARS-CoV-2 Antigen test is already available in the US and Europe.

Quest Diagnostics and Ginkgo Bioworks have entered into an agreement with the Texas Department of State Health Services (DSHS) to offer Covid-19 testing services to Kindergarten through Senior (K-12) schools. The move is aimed to facilitate safer classroom learning in Texas. Ginkgo will provide support services including online reporting and site staffing for the testing programme, while Quest will conduct polymerase chain reaction (PCR) tests and deploy various nucleic acid amplification test technologies through its labs in Houston and Dallas-Fort Worth.

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