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-TRACKTM 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-LifeTM and Improving-LifeTM 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.
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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 diagnostic capabilities of the COVI-TRACK test and its use for detecting IgG and IgM antibodies to SARS-CoV-2 in patient samples; the performance capabilities, including assay specificity and sensitivity, and time to result, of the COVI-TRACK test; the potential use and availability for distribution of the COVI-TRACK test; the capability to manufacture the COVI-TRACK test and produce test kits at certain volumes; and Sorrento’s potential position in the diagnostic 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 and clinical device studies and seeking and obtaining EUA regulatory approval for the COVI-TRACK test, including the timing of such regulatory approval; that prior test validation and performance results may not be replicated in future studies; conducting and receiving results of clinical studies for the COVI-TRACK test; the clinical and commercial success of the COVI-TRACK test for detecting IgM and IgG antibodies to SARS-CoV-2; the viability and success of using the COVI-TRACK test; clinical development risks, including risks in the progress, timing, cost, and results of clinical studies 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 of manufacturing and supplying the test kit product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVI-TRACK test strategies; 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.
Media and Investor Relations
Contact: Alexis Nahama, DVM (SVP Corporate Development)
Telephone: 1.858.203.4120
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Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.
ACE-MAB™ and G-MAB™ are trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
Seprehvir® is a registered trademark of Virttu Biologics Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and part of the group of companies owned by Sorrento Therapeutics, Inc.
All other trademarks are the property of their respective owners.
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