Sorrento Announces That COVISTIX™ (COVID-19 Virus Rapid Antigen Detection Test) Has Received a CE Mark and Registration of the Device
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Wednesday, October 20, 2021
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SAN DIEGO, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received an official CE Mark for COVISTIX and a Registration Number: BE/CA01/1-17633-00001-IVD.
Key Points:
- SAN DIEGO, Oct. 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that it has received an official CE Mark for COVISTIX and a Registration Number: BE/CA01/1-17633-00001-IVD.
- 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.
- 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.