Sorrento Therapeutics Inc. (NASDAQ: SRNE) has received an official CE Mark for COVISTIX and marketing approval from Federal Agency for Medicines and Health Products (FAMHP), enabling the company to sell the product in territories accepting the Qarad EC-Rep CE mark for marketing.
COVISTIX receives CE Mark
COVISTIX is a rapid and sensitive diagnostic test that takes around 15 minutes to detect the SARS-CoV-2 virus nucleocapsid antigen in nasopharyngeal or nasal samples of individuals supposedly having the virus.
The diagnostic test has EUA approved in Mexico by COFEPRIS, and EUA submissions with Canada, Brazil, the US, and WHO, are underway. In addition, COVISTIX demonstrated high accuracy as a general test for all-comers (i.e., COVID-19 asymptomatic and symptomatic populations) in a large independent study carried by INMEGEN (The Instituto Nacional de Medicina Genomica, Mexico). The diagnostic test has an 81% sensitivity compared to 62% sensitivity by leading Panbio rapid antigen test.
Currently, Sorrento is in talks with regional and global distributors to guarantee that COVISTIX reaches those countries that lack access to quick, accurate, and cost-effective testing.
Sorrento CEO and Chairman Dr. Henry JI said, “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. We are expanding our manufacturing capacity in anticipation of large orders and are ready to deliver tests in the tens of millions of units.”
Ram Selvaraju reiterates “Buy” rating on Sorrento stock
H.C. Wainwright analyst Ram Selvaraju reiterated his “Buy” rating in Sorrento stock with a price target of $26 following the announcement that COVISTIX had received a CE mark and commercialization approval from FAMHP. Considering most products require a CE mark before EU marketing authorization, the mark opens the door for Sorrento to enter other European markets with their diagnostic test. The analyst anticipates COVISTIX to generate considerable revenue, but his valuation assessment doesn’t include any contribution from the company’s COVID-19 therapeutics pipeline.