Sorrento announces that Covistix (COVID-19 virus rapid antigen detection test has received a CE Mark and registration of the device.
Covistix is a sensitive and rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients suspected of a SARS-CoV-2 infection.
Covistix is currently EUA-cleared in Mexico by COFEPRIS and EUA filings are underway with Canada, Brazil, WHO, and the US. In a large independent study conducted by Inmegen (The Instituto Nacional de Medicina Genomica, Mexico), Covistix demonstrated high accuracy as a general screening for all-comers (i.e. COVID-19 symptomatic and asymptomatic populations), Covistix (n=783) has an 81% sensitivity vs. 62% (n=2202) sensitivity by globally leading Panbio rapid antigen test. Sorrento is currently negotiating with global and regional distributors to ensure rapid distribution of Covistix to those countries that access to rapid, accurate and affordable testing.
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