Sorrento Announces COVISTIX COVID-19 Virus Rapid Antigen Detection Test Detects the Omicron Variant

• COVISTIX maintains its ability to detect the Omicron Variant, in addition to detecting SARS-CoV-2 and all of its major variants of concern (VoCs);
• COVISTIX has the potential to be a “Best-in-Class” rapid COVID-19 virus antigen detection test:
  • Comparative studies with all available EUA-approved COVID-19 virus rapid antigen detection tests demonstrated that COVISTIX significantly outperforms in terms of limit of detection (LOD) of the N proteins and/or live viruses of SARS-CoV-2 and its major VoCs; and
  • In a large in-field real-world clinical study for all-comers including asymptomatic patients, COVISTIX demonstrated approximately 20% higher sensitivity vs. a leading global brand (detailed results can be found at: https://www.medrxiv.org/content/10.1101/2021.09.10.21263410v1);
• COVISTIX is currently approved and marketed in Mexico, Brazil and is CE marked in Europe;
• Sorrento is constructing a new US domestic production facility in San Diego, California with an automated assembly line targeting an initial capacity of six (6) million COVISTIX tests per month;
• Sorrento is also in discussions with multiple US States for incentive packages to further expand its US manufacturing capacity pending strong US and global demand for COVISTIX tests; and
• Combining OEM and in-house manufacturing capacities, Sorrento is positioning to provide 30 million COVISTIX tests per month in the near term and expand to 50 to 100 million COVISTIX tests monthly to accommodate accelerating demand globally.

Excerpt from the Press Release:

SAN DIEGO, Dec. 27, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that initial testing of COVISTIX on recombinant N proteins demonstrated its ability to detect the Omicron variant, in addition to detecting the original SARS-CoV-2 virus and its other major VoCs such as the delta and delta-plus strains. The COVISTIX detection levels were similar for all variants. The ease of use and timely detection of Omicron infection was demonstrated by a recent case report of a Mexico patient infected with the Omicron variant detected first with COVISTIX in about 15-minutes test time. This result was confirmed a day later by RT-PCR and sequence verified a few days later to be Omicron infection.

In a laboratory setting, Sorrento has also studied the ability of COVISTIX to detect the Omicron variant compared to other Emergency Use Authorization (EUA) approved, commercially available COVID-19 virus rapid antigen tests. Initial lab results demonstrate that COVISTIX was able to detect the Omicron N protein at a significantly lower level than other commercially available tests. With a difficulty to detect the Omicron N protein at low levels, some of the EUA-approved and marketed rapid tests may have a tough time detecting the Omicron infection at a reasonable sensitivity. False negative readings for infected asymptomatic patients could lead to a false sense of security and the inability to control outbreaks and achieve normal social and business routines.

Sorrento currently has the capacity to produce 30,000,000 COVISTIX tests a month and is currently building up its manufacturing capacity in the US. The company anticipates having a fully automated assembly line capable of producing 6,000,000 COVISTIX units per month up and running in Q1 2022. Pending US and global demand, this capacity could potentially be increased to over 100 million monthly in 2022.

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, COVI-AMG™, COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™ and COVISTIX™.

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