Sorrento Announces That COVISTIX™ (COVID-19 Virus Rapid Antigen Detection Test) Has Received a CE Mark and Registration of the Device
- COVISTIX has received CE mark and marketing authorization from FAMHP (Federal Agency for Medicines and Health Products) that enables Sorrento to sell this device in all territories that accept the Qarad EC-Rep (Belgium) CE Mark for commercialization.
- Distribution contracts are being negotiated.
Excerpt from the Press Release:
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. 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.
“This is a significant milestone for Sorrento and we appreciate the cooperation with European authorities to bring our highly sensitive antigen test to help control this pandemic,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “We are expanding our manufacturing capacity in anticipation of large orders and are ready to deliver tests in the tens of millions of units.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
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