Sorrento Receives Licensure From the State of California for Clinical Testing Laboratory (CLIA) Allowing for Clinical Sample Testing

Sorrento receives Clinical Laboratory Improvement Amendments (CLIA) license from the State of California for clinical sample testingSorrento intends to initially offer three diagnostic tests for SARS-CoV-2 infection:– RT-PCR Emergency Use Authorization (EUA)-approved test using nasal pharyngeal swab– Laboratory developed test (COVI-STIX™) using shallow nasal swab– Laboratory developed test (COVI-TRACE™) using shallow nasal swab
SAN DIEGO, Dec. 08, 2020 (GLOBE NEWSWIRE) — 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’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.comForward-Looking StatementsContact
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.comSorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.SEMDEXA ™ is a trademark of Semnur Pharmaceuticals, Inc.ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.