Sorrento Receives Licensure From the State of California for Clinical Testing Laboratory (CLIA) Allowing for Clinical Sample ...
December 08 2020 - 8:05PM
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced
today that it has received CLIA Licensure from the State of
California that permits testing of clinical samples. The Company
intends to initially focus on testing for SARS-CoV-2 infection but
expects to expand to include immuno-oncology tests to support its
clinical trials.
Sorrento expects to establish field sites for
the collection of samples and initially intends to offer three
independent tests for SARS-CoV-2 infection:
- A standard RT-PCR EUA-approved test
with immediate processing and results are generally reported within
three hours of sample testing.
- A laboratory developed rapid lateral flow antigen test
(COVI-STIX) for nasal swab specimens that has, to date,
demonstrated comparable sensitivity and specificity to the RT-PCR
EUA-approved test. The COVI-STIX test is expected to provide a
qualitative result within 20 minutes.
- A laboratory developed
High-Performance Loop-mediated isothermal amplification (HP-LAMP)
test for detection of viral RNA (COVI-TRACE) in shallow nasal swab
specimens. The COVI-TRACE test is expected to provide a qualitative
result within 30 minutes.
Sorrento intends to provide test reports for its COVI-STIX and
COVI-TRACE tests to patients within an hour of test completion. In
parallel, Sorrento continues to generate the data required for EUA
applications for the COVI-STIX and COVI-TRACE tests and anticipates
submitting the applications shortly.
“The addition of a CLIA-licensed laboratory will allow Sorrento
to commence generating revenues from clinical sample testing,”
stated Dr. Henry Ji, Chairman and CEO of Sorrento. “The ability to
analyze clinical samples from our ongoing and future clinical
trials in-house rather than out-sourcing to other CLIA facilities
may also result in accelerated turn-around time, increased
flexibility and potentially, significant direct savings.”
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™ 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 StatementsThis 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 expectation that Sorrento will
initially offer three diagnostic tests for SARS-CoV-2 infection,
including the RT-PCR EUA approved test, COVI-STIX and COVI-TRACE;
the potential use and availability for distribution of the RT-PCR
EUA approved test, COVI-STIX and COVI-TRACE; the expected timing
for generating and reporting test results; expanding the clinical
testing laboratory to include immuno-oncology tests to support
Sorrento’s clinical trials; establishing field sites for the
collection of testing samples; the anticipated timing for
completing EUA submissions for COVI-STIX and COVI-TRACE; the
potential receipt of any EUA for COVI-STIX or COVI-TRACE; the
potential for Sorrento to generate revenue from clinical sample
testing from a CLIA laboratory; the potential for Sorrento’s CLIA
laboratory to accelerate turn-around time for testing of clinical
samples from Sorrento’s clinical trials, to increase flexibility or
to result in any direct savings; 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 establishing a CLIA
laboratory; 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 approvals for
COVI-TRACE and COVI-STIX, including the timing for such regulatory
approvals; 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.
ContactAlexis Nahama, DVM (SVP Corporate
Development)Email: mediarelations@sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks
of Sorrento Therapeutics, Inc.G-MAB™, CAR-T™, DAR-T™,
COVI-GUARD™, COVI-AMG™, COVI-SHIELD™, Gene-MAb™, COVI-DROPS™,
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.
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