Sorrento Announces That COVISTIX™ (COVID-19 Virus Rapid Antigen Detection Test) Has Received a CE Mark and Registration of the Device
October 20 2021 - 1:37PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today
announced that it has received an official CE Mark for COVISTIX and
a Registration Number: BE/CA01/1-17633-00001-IVD. COVISTIX is a
sensitive and rapid (approximately 15-minute) diagnostic test for
the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal
or nasopharyngeal samples of patients suspected of a SARS-CoV-2
infection.
COVISTIX is currently EUA-cleared in Mexico by
COFEPRIS and EUA filings are underway with Canada, Brazil, WHO, and
the US. In a large independent study conducted by
INMEGEN (The Instituto Nacional de Medicina Genomica, Mexico),
COVISTIX demonstrated high accuracy as a general screening for
all-comers (i.e. COVID-19 symptomatic and asymptomatic
populations), COVISTIX (n=783) has an 81% sensitivity vs. 62%
(n=2202) sensitivity by globally leading Panbio rapid antigen
test.
Sorrento is currently negotiating with global
and regional distributors to ensure rapid distribution of COVISTIX
to those countries that access to rapid, accurate and affordable
testing.
“This is a significant milestone for Sorrento
and we appreciate the cooperation with European authorities to
bring our highly sensitive antigen test to help control this
pandemic,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “We
are expanding our manufacturing capacity in anticipation of large
orders and are ready to deliver tests in the tens of millions of
units.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease and COVID-19.
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”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including Abivertinib, COVIGUARD™, COVI-AMG™,
COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test
solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
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 COVISTIX; the performance capabilities of COVISTIX,
including its sensitivity and specificity; the speed at which
COVISTIX provides results or is able to provide results; the
potential receipt of any approvals in Canada, Brazil and the US,
and from WHO; the expected entry into distribution agreements to
enable rapid distribution of COVISTIX; Sorrento’s manufacturing
capacity and ability to produce and deliver a high volume of
COVISTIX tests; and Sorrento’s potential position in the
diagnostics and therapeutics industries. 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 additional studies and
seeking regulatory approval for COVISTIX, 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, study and trial 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, 2020, 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.
ContactAlexis 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™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ 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.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
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