Sorrent Therapeutics (SRNE) gets EUA approval

Sorrento Therapeutics (SRNE) announced its receipt of EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number “OFICIO: CAS/10720/2021”, it is establishing a local “Sorrento Mexico Ltd” subsidiary to manage commercial operations in Mexico.

COVI-STIX is a sensitive and rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients. COFEPRIS issued Emergency Use Authorization (EUA) approval and an importation permit for COVI-STIX on June 14, 2021.

Sorrento will commercially launch the COVI-STIX test in Mexico with the first shipments expected to be delivered in July.

Yesterday, the company entered into a agreement with the U.S. Navy for research. Under the terms of the agreement, NAMRU-3 will conduct surveillance and clinical validation research, and Sorrento will provide technical expertise and access to its portfolio of products to combat the SARS-CoV-2 and threats emerging due to variants of concern.

The mission of NAMRU-3 is to ensure warfighter readiness through detecting, deterring, and responding to infectious disease threats through integration with partners throughout U.S. Africa Command (AFRICOM), Central Command (CENTCOM), and European Command (EUCOM) areas of responsibility. The purpose of this collaboration is to perform infectious disease research that guides the Department of Defense (DoD), informs public health policy of host nation partners, and improves medical readiness of the U.S. Armed Forces across NAMRU-3 areas of responsibility. Through shared resources and logistical support, the overall goal of this research cooperation will be to conduct research on current, emerging and re-emerging infectious diseases, to enhance Force Health Protection, and provide critical data regarding countermeasures to mitigate infectious disease transmission including surveillance and product development.