Replies to post #10163 on Sorrento Therapeutics Inc (SRNE)

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SORRENTO ANNOUNCES ADDITION OF COVI-STIX(TM) (COVID-19 VIRUS RAPID ANTIGEN DETECTION TEST) TO THE OFFICIAL MEXICAN GOVERNMENT LIST OF EMERGENCY USE APPROVED POINT OF CARE RAPID ANTIGEN TESTS
COVI-STIX has been added to the official government list of point of care rapid antigen tests useful for the detection of SARS-CoV-2 in Mexico ( https://www.gob.mx/salud/documentos/listado-de-pruebas-de-antigeno-para-sars-cov-2 ).
COVI-STIX outperformed among the tests listed for both sensitivity and specificity as reported by the Instituto de Diagnóstico y Referencia Epidemiológicos (InDRE), an independent government testing laboratory.

Sorrento has initiated importation and commercial roll-out activities for Mexico and expects the product to be commercially available in-market within weeks.

SAN DIEGO, June 02, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today 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%) .

Government listing and third-party validation data can be found at:

https://www.gob.mx/salud/documentos/listado-de-pruebas-de-antigeno-para-sars-cov-2

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 their testing capabilities.

With today’s approval, Sorrento is able to offer a high quality and affordable diagnostic solution for Mexico. This approval is expected to form the foundation for similar clearances in other Latin American countries, including Brazil, in which Sorrento is currently conducting multiple therapeutic clinical trials.

“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.”