Sorrento Announces It Has Submitted an Emergency Use Authorization (EUA) Application for the COVI-TRACK Diagnostic Test for the Detection of Antibodies to SARS-CoV-2

SAN DIEGO, June 10, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that an Application for Emergency Use Authorization (EUA) is under review at the U.S. Food and Drug Administration (FDA) for its COVI-TRACK^TM in vitro diagnostic test kit for the independent detection of IgG and IgM antibodies in sera of patients exposed to the SARS-CoV-2 virus.

The rapid antibody test allows for results to be available in eight minutes or less. The easy to use assay develops three clear lines that confirm the assay validity and the qualitative detection and differentiation of IgM and IgG antibodies to the SARS-CoV-2 virus.

Analytical validation was performed by testing sample cohorts from healthy donors and confirmed positive COVID-19 patient samples by RT-PCR testing, and the assay demonstrated a specificity greater than 97% and diagnostic sensitivity of greater than 94%. Upon issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. Sorrento has secured manufacturing capacity to support the production of up to five million test kits per month.

About Sorrento Therapeutics, Inc. 

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers. Sorrento's multimodal multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir”). Sorrento is also developing potential antiviral therapies, and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD and COVI-SHIELD.

Sorrento's commitment to medicine and therapy for Saving-Life^TM and Improving-Life^TM is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX is completing a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido was approved by the FDA on February 28, 2018.