NEW YORK – Sorrento Therapeutics announced on Wednesday that its Covistix SARS-CoV-2 rapid antigen test has received CE marking.
The test detects the nucleocapsid antigen of the virus from nasal or nasopharyngeal samples and returns results in about 15 minutes. In an independent study of 783 people, both asymptomatic and symptomatic, the test had 81 percent sensitivity, the company said in a statement.
The test has received regulatory clearance in Mexico, and Sorrento said its Emergency Use Authorization with the US Food and Drug Administration is underway. EUAs are also underway in Canada, Brazil, and the World Health Organization, the company added.
The San Diego-based firm is negotiating with global and regional distributors to rapidly distribute the test to countries that need access to "rapid, accurate, and affordable testing," it added.
Henry Ji, the company's chairman and CEO, said in a statement that Sorrento is expanding its manufacturing capacity and is ready to deliver "tens of millions" of tests.
Sorrento also offers its Covitrace test, which detects SARS-CoV-2 in nasal swabs and saliva at the point of care, and Covitrack Platinum test to detect antibodies to the virus in blood.
Earlier this year, the company partnered with Mexico's National Institute of Genomic Medicine to develop a range of diagnostics and therapeutics for COVID-19 for the Mexican market.