Sorrento Announces the Submission of a Marketing Authorization Application to COFEPRIS (Mexico) for COVI-STIX™ Rapid Detection Test of SARS-CoV-2 Viral Antigen

Rhea-AI Summary

Sorrento Therapeutics has submitted a Marketing Authorization Application for its COVI-STIX rapid diagnostic test in Mexico to COFEPRIS, the country's health authority. This test detects the SARS-CoV-2 virus nucleocapsid antigen in nasal samples. Testing has demonstrated results within 15 minutes, with detections occurring as quickly as two minutes for high viral loads. An independent study confirmed high sensitivity and specificity in COVID-19 symptomatic patients in Mexico.

Positive

• COVI-STIX demonstrated results within 15 minutes, with detection as quick as two minutes for high viral loads.
• Independent studies confirmed high sensitivity and specificity of COVI-STIX in symptomatic COVID-19 patients.

Negative

• None.

SAN DIEGO, Dec. 30, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that a Marketing Authorization Application has been submitted by its agents in Mexico to Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the health regulatory authority for Mexico, for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients, "Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2".

In testing conducted to date, COVI-STIX has provided results within 15 minutes, with positive detection as quickly as two minutes for patient samples with high viral load.

An independent study conducted by researchers of the Facultad de Medicina, UNAM demonstrated high sensitivity and specificity in Mexico patients with COVID-19 symptoms.

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 (“ADC”), and clinical stage oncolytic virus (“Seprehvir^®”).  Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene-MAb™, COVI-MSC™ and COVI-DROPS™; and diagnostic test solutions, including COVI-TRACK™, COVI-STIX™ and COVI-TRACE™.

Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido^® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido^® was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the potential receipt of any clearance for COVI-STIX from COFEPRIS; the speed at which COVI-STIX provides results or is able to provide results, including positive detection of the SARS-CoV-2 virus nucleocapsid antigen; the specificity and sensitivity of COVI-STIX; and Sorrento’s potential position in the diagnostics testing industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to conducting pre-clinical studies and seeking regulatory approval for COVI-STIX, including the timing for receipt of any such approval; conducting and receiving results of clinical trials; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVID-19 therapeutic product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Contact
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.com

Sorrento^® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene-MAb™, COVI-DROPS™, COVI-MSC™, COVI-TRACK™, COVI-TRACE™ and COVI-STIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido^® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

©2020 Sorrento Therapeutics, Inc. All Rights Reserved.

FAQ

What is the latest news about Sorrento Therapeutics (SRNE)?

Sorrento Therapeutics submitted a Marketing Authorization Application for its COVI-STIX rapid diagnostic test to COFEPRIS in Mexico.

What does the COVI-STIX rapid test detect?

COVI-STIX detects the SARS-CoV-2 virus nucleocapsid antigen in nasal samples.

How quickly can COVI-STIX provide test results?

COVI-STIX can provide test results within 15 minutes, and positive detection can occur as quickly as two minutes.

What were the results of the studies on COVI-STIX?

Independent studies showed that COVI-STIX has high sensitivity and specificity in patients with COVID-19 symptoms.