Sorrento Announces It Has Submitted an Emergency Use Authorization (EUA) Application for the COVI-TRACK Diagnostic Test for t...
June 10 2020 - 9:57PM
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.
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 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 RelationsContact: Alexis
Nahama, DVM (SVP Corporate Development)Telephone:
1.858.203.4120Email: mediarelations@sorrentotherapeutics.com
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. © 2020 Sorrento Therapeutics, Inc. All
Rights Reserved.
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