28th June 2021 Product update: Sorrento Therapeutics
COVID-19 Antigen Test Approved For Widespread Use in Mexico
Sorrento Therapeutics has announced that the Mexican Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the health regulatory authority for Mexico, has listed COVI-STIX on its official government website list of rapid antigen tests approved for emergency use in Mexico.
COVI-STIX is a rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients ("Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2").
An independent study conducted by the government’s epidemiological department, Instituto de Diagnóstico y Referencia Epidemiológicos (InDRE), confirmed the validity of the test in 465 nasopharyngeal samples from symptomatic (7 days or less) or uninfected people, which yielded the following results: Positive Predictive Value (PPV): 95.77%; Negative Predictive Value (NPV): 98.42%. Among all the products listed currently, COVI-STIX outperformed for both sensitivity (91.89%) and specificity (99.23%).
With close to 2.4M COVID-19 cases and over 225,000 attributable deaths to date, Mexico has been severely impacted by the spread of the coronavirus pandemic, and the government is actively looking at better options to expand its testing capabilities.
“We are very grateful to COFEPRIS for working with us closely on this review and listing us for use in Mexico,” stated Dr. Henry Ji, Chairman, and CEO of Sorrento. “We look forward to working even more closely with the Mexican government to help deploy our test at scale. We have been building our manufacturing capacity in anticipation of this day and are ready to deliver tests in the tens of millions of units monthly.”
It is establishing a local “Sorrento Mexico Ltd” subsidiary to manage commercial operations in Mexico and will launch the COVI-STIX test in Mexico, with the first shipments expected to be delivered in July.
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Date Published: 28th June 2021
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