Sorrento Announces Rapid COVISTIX COVID-19 Virus Antigen Test Detects Omicron Variant
- COVISTIX maintains its ability to detect the Omicron variant, in addition to detecting SARS-CoV-2 and all of its major variants of concern (VoC);
- COVISTIX has the potential to be a ‘best in class’ COVID-19 virus antigen rapid test:
- Comparative studies with all EUA approved COVID-19 virus antigen rapid detection assays have shown that COVISTIX significantly outperforms in terms of limit of detection (LOD) of live N-proteins and / or viruses of SARS- CoV-2 and its main VoCs; and
- In a large clinical field study under real conditions for all, including asymptomatic patients, COVISTIX demonstrated approximately 20% higher sensitivity compared to a leading global brand (detailed results are available at: https: // www .medrxiv.org / content / 10.1101 / 2021.09.10.21263410v1);
- COVISTIX is currently approved and marketed in Mexico, Brazil and is CE marked in Europe;
- Sorrento is building a new US domestic production facility in San Diego, California with an automated assembly line targeting an initial capacity of six (6) million COVISTIX tests per month;
- Sorrento is also in talks with several US states for incentive programs to further expand its manufacturing capacity in the US pending strong US and global demand for COVISTIX testing; and
- By combining OEM and in-house manufacturing capabilities, Sorrento is positioning itself to deliver 30 million COVISTIX tests per month in the short term and grow to 50-100 million COVISTIX tests per month to meet accelerating global demand.
SAN DIEGO, December 27, 2021 (GLOBE NEWSWIRE) – Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today announced that the first tests of COVISTIX on recombinant N proteins have demonstrated its ability to detect the variant Omicron, in addition to detecting the original SARS-CoV-2 virus and its other major VoCs such as delta and delta-plus strains. COVISTIX detection levels were similar for all variants. The ease of use and rapid detection of infection with Omicron was demonstrated by a recent case report of a Mexican patient infected with the Omicron variant first detected with COVISTIX within approximately 15 minutes of testing time. This result was confirmed a day later by RT-PCR and the sequence was verified a few days later as being an infection with Omicron.
In the laboratory, Sorrento also studied the ability of COVISTIX to detect the Omicron variant against other rapid COVID-19 virus antigen tests approved by the Emergency Use Authorization (EUA) and available in the trade. The first laboratory results show that COVISTIX was able to detect the Omicron N protein at a level significantly lower than that of other commercially available tests. With difficulty in detecting Omicron N protein at low levels, some of the rapid tests approved and marketed by the EUA may struggle to detect Omicron infection with reasonable sensitivity. False negative readings for asymptomatic infected patients could lead to a false sense of security and the inability to control outbreaks and perform normal social and business routines.
Sorrento currently has the capacity to produce 30,000,000 COVISTIX tests per month and is currently strengthening its manufacturing capacity in the United States. The company plans to have a fully automated assembly line capable of producing 6,000,000 COVISTIX units per month operational in the first quarter of 2022. Pending US and global demand, this capacity could potentially be increased to over 100 million. per month in 2022.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical and commercial biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune diseases and COVID-19. Sorrento’s multimodal, multidimensional approach to cancer control is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB ™ library”), immuno-therapies -cellular (“DAR-T ™”), antibody-drug conjugates (“ADC”) and oncolytic virus (“Seprehvec ™”). Sorrento is also developing antiviral therapies and potential coronavirus vaccines, including Abivertinib, COVI-AMG ™, COVISHIELD ™, COVI-MSC ™ and COVIDROPS ™; and diagnostic test solutions, including COVITRACK ™ and COVISTIX ™.
Sorrento’s commitment to life-enhancing therapies is also demonstrated by our efforts to advance a first-class, non-opioid small-molecule pain management (TRPV1 agonist), resiniferatoxin (“RTX”) and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA ™), a new viscous gel formulation of a corticosteroid widely used for epidural injections to treat lumbosacral radicular pain, or sciatica, and for market ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia. RTX has completed a Phase 1B trial for intractable pain associated with cancer and a Phase 1B trial in patients with osteoarthritis. 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.
This press release and all statements made for and during any presentation or meeting contain forward-looking statements relating 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. which could cause actual results to differ materially from those projected. Forward-looking statements include statements about COVISTIX, including its sensitivity and specificity, limit of detection and the rate at which COVISTIX provides results or is able to provide results; the ability of COVISTIX to detect SARS-CoV-2 and its major variants of concern (VoC), including the Omicron variant; the performance capabilities of COVISTIX, including against the rapid detection tests for COVID-19 virus antigens approved by the EUA; Sorrento’s current and planned future manufacturing capacity for COVISTIX, including the expected timeframe for capacity expansion and the potential for production expansion in one or more US states based on state incentives; and Sorrento’s potential position in the diagnostic industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, without limitation: risks relating to the technologies and prospects of Sorrento and its subsidiaries, affiliates and partners and collaborations with partners, including, but not limited to, risks associated with performing additional studies and seeking regulatory approval for COVISTIX, including the timing of receipt of such approval; conduct and receive the results of clinical studies; clinical development risks, including risks relating to the progress, timing, costs and results of clinical studies and product development programs; risk of difficulties or delays in obtaining regulatory approvals; the risks that the results of a clinical study will not meet all or part of the parameters of a clinical study and that the data generated from these studies may not support a regulatory submission or approval; the risks that the results of previous trials, studies and trials will not be reproduced in future studies and trials; business risks associated with COVISTIX, including expectations regarding demand and market acceptance of COVISTIX; expectations regarding the maintenance and strengthening of its relationships with partners and customers; the risks of manufacturing and supplying COVISTIX nationally and globally; risks associated with using the expertise of its employees, subsidiaries, affiliates and partners to assist the company in the execution of its COVID-19 product candidate strategies; risks associated with the global impact of COVID-19; and other risks which 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 fiscal 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 out in those documents. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and we assume no obligation to update any forward-looking statements contained in this press release, unless the law requires it.
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G-MAB ™, DAR-T ™, Seprehvec ™, SOFUSA ™, COVI-AMG ™, COVISHIELD ™, COVIDROPS ™, COVI-MSC ™, COVITRACK ™ and COVISTIX ™ are trademarks of Sorrento Therapeutics, Inc.
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