COVISTIX COVID-19 virus rapid antigen detection test detects the Omicron variant.

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.

COVISTIX has CE Mark and is filed at the FDA.