Sorrento Announces It Has Submitted An Emergency Use Authorization (EUA) Application to the FDA for COVI-STIX™ Rapid Test for the Detection of SARS-CoV-2 Viral Antigen
Sorrento Therapeutics, Inc. (Nasdaq: SRNE) has submitted an Emergency Use Authorization (EUA) Application to the FDA for its COVI-STIX rapid diagnostic test aimed at detecting SARS-CoV-2 virus nucleocapsid antigen in nasal samples. Results from COVI-STIX can be obtained in as little as 15 minutes, with positive detection as quick as two minutes for samples with high viral loads. Sorrento is focused on developing therapies for cancer and coronavirus treatments, including various antiviral therapies and diagnostic solutions.
- COVI-STIX provides results within 15 minutes, improving patient testing efficiency.
- Rapid detection capability of COVI-STIX can detect high viral loads in as quickly as two minutes.
- Potential FDA EUA approval could expand Sorrento's position in the diagnostics market.
- COVI-STIX's EUA application is subject to regulatory approval, introducing uncertainty.
- Challenges in manufacturing and supplying the diagnostic tests could impact availability.
SAN DIEGO, Dec. 22, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that an Emergency Use Authorization (EUA) Application has been submitted to the US Food and Drug Administration for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients.
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.
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 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)
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 EUA for COVI-STIX; 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; the ease and flexibility of COVI-STIX and the potential for the ease and flexibility thereof to allow for large scale use; Sorrento’s manufacturing capacity and expectations regarding the number of tests that can be produced per month; 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 EUA 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
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