Sorrento Therapeutics has picked up a saliva-based coronavirus test developed by fertility researchers at Columbia University that aims to provide an easy-to-read result in less than 30 minutes.
The entirety of the single-step test, to be dubbed COVI-TRACE, is contained within a small tube—it requires no laboratory equipment and can be used just about anywhere.
After depositing saliva into the vial and applying a little heat, enzymes and reagents react to the presence of the virus’s RNA and change the color of the liquid from red to yellow to indicate a positive result.
"Testing for SARS-CoV-2 needs to be fast, frequent and far-reaching,” said Zev Williams, director of the university’s fertility center. “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."
The test was built off of technology used by Columbia fertility specialists to look for genetic abnormalities in embryos prior to implantation—including a molecular diagnostic technique called loop-mediated isothermal amplification, or LAMP, which they previously employed for a nasal swab test for COVID-19.
A preliminary, preprinted study by Williams and colleagues pegged the saliva test’s sensitivity and specificity at 97% and 100%, respectively, resulting in very low rates of false negatives and false positives. In addition, the test showed it could detect very few copies of viral RNA in saliva samples as small as a microliter.
"Once we obtain regulatory approval, we envision the test being used to screen people before they board an airplane, visit a nursing home, or go to school or summer camp," Williams said earlier this summer. "The test could also be a more affordable option for health care facilities in developing countries where outbreaks have overwhelmed their testing and logistical capabilities.”
Sorrento’s licensing deal with Columbia is not the drugmaker’s first COVID-19 venture in the New York City area. The drugmaker previously teamed up with Mount Sinai Health System to develop a cocktail of antibody treatments for the pandemic, and it has its eyes on launching phase 1 clinical trials before October.
"We are building a portfolio of highly relevant COVID-19 solutions that spans diagnostics, prevention, early intervention and rescue therapies,” said Sorrento Chairman and CEO Henry Ji.
“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,” Ji said. “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.”