- COVI-STIX outperformed among the many exams listed for each sensitivity and specificity as reported by the Instituto de Diagnóstico y Referencia Epidemiológicos (InDRE), an unbiased authorities testing laboratory.
- Sorrento has initiated importation and industrial roll-out actions for Mexico and expects the product to be commercially obtainable in-market inside weeks.
SAN DIEGO, June 02, 2021 (GLOBE NEWSWIRE) — Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) right now introduced that the Mexican Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS), the well being regulatory authority for Mexico, has listed COVI-STIX on its official authorities web site checklist of fast antigen exams authorised for emergency use in Mexico.
COVI-STIX is a fast (roughly 15-minute) diagnostic check for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of sufferers (“Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2“).
An unbiased research carried out by the federal government’s epidemiological division, Instituto de Diagnóstico y Referencia Epidemiológicos (InDRE), confirmed the validity of the check in 465 nasopharyngeal samples from symptomatic (7 days or much less) or uninfected folks, which yielded the next outcomes: Constructive Predictive Worth (PPV): 95.77%; Detrimental Predictive Worth (NPV): 98.42%. Amongst all of the merchandise listed at present, COVI-STIX outperformed for each Sensitivity (91.89%) and Specificity (99.23%).
Authorities itemizing and third-party validation knowledge will be discovered at:
With near 2.4M COVID-19 instances and over 225,000 attributable deaths thus far, Mexico has been severely impacted by the unfold of the coronavirus pandemic, and the federal government is actively taking a look at higher choices to increase their testing capabilities.
With right now’s approval, Sorrento is ready to provide a top quality and reasonably priced diagnostic answer for Mexico. This approval is anticipated to kind the muse for comparable clearances in different Latin American international locations, together with Brazil, during which Sorrento is at present conducting a number of therapeutic scientific trials.
“We’re very grateful to COFEPRIS for working with us intently on this assessment and itemizing us to be used in Mexico,” acknowledged Dr. Henry Ji, Chairman and CEO of Sorrento. “We sit up for working much more intently with the Mexican authorities to assist deploy our check at scale. We’ve got been constructing our manufacturing capability in anticipation of at the present time and are able to ship exams within the tens of hundreds of thousands of items month-to-month.”
About Sorrento Therapeutics, Inc.
Sorrento is a scientific stage, antibody-centric, biopharmaceutical firm creating new therapies to deal with cancers and COVID-19. Sorrento’s multimodal, multipronged strategy to combating most cancers is made attainable by its intensive immuno-oncology platforms, together with key belongings corresponding to absolutely human antibodies (“G-MAB™ library”), scientific stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and scientific stage oncolytic virus (“Seprehvir™”). Sorrento can be creating potential antiviral therapies and vaccines towards coronaviruses, together with COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic check options, together with COVITRACK™, COVI-STIX™ and COVITRACE™.
Sorrento’s dedication to life-enhancing therapies for sufferers can be demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid ache administration small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a broadly used corticosteroid for epidural injections to deal with lumbosacral radicular ache, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the therapy of post-herpetic neuralgia. RTX has accomplished a Section IB trial for intractable ache related to most cancers and a Section 1B trial in osteoarthritis sufferers. SEMDEXA is in a pivotal Section 3 trial for the therapy of lumbosacral radicular ache, or sciatica. ZTlido® was authorised by the FDA on February 28, 2018.
For extra data go to www.sorrentotherapeutics.com
This press launch and any statements made for and through any presentation or assembly include forward-looking statements associated to Sorrento Therapeutics, Inc., below the secure harbor provisions of Part 21E of the Non-public Securities Litigation Reform Act of 1995 and topic to dangers and uncertainties that might trigger precise outcomes to vary materially from these projected. Ahead-looking statements embrace statements relating to the pace at which COVI-STIX offers outcomes or is ready to present outcomes; the constructive predictive worth, damaging predictive worth, specificity and sensitivity of COVI-STIX; the anticipated high quality and affordability of COVI-STIX; the potential receipt of any approvals in different Latin American international locations, together with Brazil; Sorrento’s manufacturing capability and talent to provide and ship a excessive quantity of COVI-STIX exams; and Sorrento’s potential place within the diagnostics and therapeutics industries. Dangers and uncertainties that might trigger our precise outcomes to vary materially and adversely from these expressed in our forward-looking statements, embrace, however usually are not restricted to: dangers associated to Sorrento’s and its subsidiaries’, associates’ and companions’ applied sciences and prospects and collaborations with companions, together with, however not restricted to dangers associated to conducting further research and searching for regulatory approval for COVI-STIX, together with the timing for receipt of any such approval; conducting and receiving outcomes of scientific trials; scientific growth dangers, together with dangers within the progress, timing, price, and outcomes of scientific trials and product growth applications; threat of difficulties or delays in acquiring regulatory approvals; dangers that scientific research outcomes might not meet all or any endpoints of a scientific research and that any knowledge generated from such research might not help a regulatory submission or approval; dangers that prior check, research and trial outcomes will not be replicated in future research and trials; dangers of producing and supplying drug product; dangers associated to leveraging the experience of its staff, subsidiaries, associates and companions to help the corporate within the execution of its COVID-19 therapeutic product candidates methods; dangers associated to the worldwide influence of COVID-19; and different dangers which are described in Sorrento’s most up-to-date periodic studies filed with the Securities and Trade Fee, together with Sorrento’s Annual Report on Type 10-Okay for the 12 months ended December 31, 2020, and subsequent Quarterly Stories on Type 10-Q filed with the Securities and Trade Fee, together with the danger components set forth in these filings. Buyers are cautioned to not place undue reliance on these forward-looking statements, which communicate solely as of the date of this launch and we undertake no obligation to replace any forward-looking assertion on this press launch besides as required by regulation.
Alexis Nahama, DVM (SVP Company Growth)
E mail: email@example.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.
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