On February 17, 2022 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") reported the acquisition of a majority ownership of Zhengzhou Fortune Bioscience Co., Ltd. ("FortuneBio") (Press release, Sorrento Therapeutics, FEB 17, 2022, View Source [SID1234608260]). This acquisition is in response to dramatically increasing demands worldwide and planned product build-up in anticipation of potential additional approvals for Sorrento’s COVISTIXTM COVID-19 VIRUS Rapid Antigen Detection Test.
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FortuneBio specializes in the manufacture of lateral flow diagnostic tests with numerous approved products marketed in over 20 countries for pregnancy tests, fecal occult blood test, and drug abuse test kits. FortuneBio has an ISO 13885 facility and is capable of producing tens of millions of lateral flow tests per month. FortuneBio is currently expanding production capabilities to meet COVISTIX demand worldwide.
COVISTIX is a sensitive and rapid antigen diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients. "While most rapid antigen tests are negatively impacted with a reduced LoD sensitivity to the Omicron variant1, in a laboratory setting with live Omicron viruses, COVISTIX demonstrated the ability to detect the Omicron variant at an even lower LoD as compared to that of the original SARS-CoV-2 strain. Our lateral flow antigen test uses a platinum colloid coupled with a pair of specific antibodies to give a clear black line if virus is present, in contrast to many tests which use a gold colloid which results in a pink or red line. This proprietary platinum colloid technology is what contributes to our improved Omicron LoD sensitivity," said Brian Cooley, Sorrento’s SVP for Drug Delivery and Diagnostics.
"COVISTIX demand is increasing rapidly worldwide due to its high sensitivity as compared with other EUA-approved tests. By acquiring a majority stake in FortuneBio, Sorrento is in a better position to rapidly respond to the ever-changing demand of rapid COVID testing and broaden our diagnostic product offering to other areas such as early cancer diagnostics," stated Dr. Henry Ji, Chairman and CEO of Sorrento. "In addition to providing product revenue from an established portfolio of approved diagnostic tests, FortuneBio gives Sorrento an experienced diagnostic research, development and manufacturing team and an ISO-certified facility to rapidly advance and commercialize our antibody-enabled diagnostic products in synergy with our antibody therapeutics."
1SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | FDA https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests