Sorrento Therapeutics to Market Columbia University’s Rapid On-Site Detection Test for SARS-CoV-2 Virus in Saliva

(San Diego, CA, USA) has entered into a licensing agreement with Columbia University (New York, NY, USA) for the rights to a rapid, one-step diagnostic test that detects the SARS-CoV-2 virus in 30 minutes from a sample of saliva.

Unlike other commercially available diagnostic products, the test developed by Columbia University's team, to be marketed by Sorrento under the COVI-TRACE name, holds all of the testing materials in a single tube and requires no specialized laboratory equipment, making it easily deployable for point of care, on-site or potentially at-home testing.

Current diagnostic tests for SARS-CoV-2 detect viral ribonucleic acid (RNA) but must be shipped to a reference laboratory unless the facility collecting the samples has purchased costly instrumentation, cartridges and consumables to extract viral RNA from the fluid in which the sample, either a nasopharyngeal swab or saliva, is placed. The current backlog in SARS-CoV-2 testing has resulted in average turnaround times of between several days to over a week, and laboratories across the country are reportedly struggling to keep up with increased testing demand.

However, the COVI-TRACE approach developed by Columbia University's team eliminates the extraction step and simplifies overall sample processing. A small sample of saliva is collected in a cup and then placed into a tube containing enzymes and reagents that can detect the SARS-CoV-2 virus's RNA. The tube is then placed into a simple heat block or water bath to keep the sample warm throughout the chemical reaction, which takes 30 minutes or less to provide a colorimetric reading based on detection of the presence of the virus. A study that evaluated the new test in 60 samples, including 30 samples with virus and 30 without, found sensitivity and specificity of 97% and 100%, respectively, and the ability to detect as few as one or two copies of the SARS-CoV-2 virus in a microliter of saliva.

"Testing for SARS-CoV-2 needs to be fast, frequent, and far-reaching. We are delighted to work with Sorrento Therapeutics in the hope that COVI-TRACE may be scaled and deployed in the U.S. and around the world to combat the spread of COVID-19," said Dr. Zev Williams, Director of the Columbia University Fertility Center.

"We are building a portfolio of highly relevant COVID-19 solutions that spans diagnostics, prevention, early intervention and rescue therapies," said Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, Inc. "COVI-TRACE will be a key asset in our diagnostic solutions, and we intend to move rapidly to submit an emergency use authorization request to the FDA and prepare for full-scale production. Such a simple, deployable and cost-effective solution, in synergy with our potentially neutralizing antibodies, could become the 'economy opener' our country has been waiting for."

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Sorrento Therapeutics, Inc.
Columbia University