VANCOUVER – Sorrento Therapeutics Inc., which is working to build a comprehensive lineup of COVID-19 products, has in-licensed a self-contained test for SARS-CoV-2 that may produce accurate results in half an hour.
Sorrento, a San Diego-based biotech company, licensed the test for global distribution from the Columbia University Fertility Center. The test was developed by Zev Williams and his team at the Columbia University Irving Medical Center, which published results of preliminary studies in MedRxiv June 16, 2020, based on 60 samples (30 with the virus and 30 without) that showed sensitivity of 97% and specificity of 100%.
The test is self-contained, with all the materials included in a test tube. The test relies on a saliva sample – as opposed to a nasal swab – that is mixed with a testing reagent and incubated in a heating cube or hot water bath at 63 degrees Celsius. After 30 minutes, the test delivers a result, turning yellow for a positive result and red for negative. Sorrento intends to market the test as Covi-Trace.
To date, the most commonly used tests for SARS-CoV-2 detect viral ribonucleic acid (RNA) and must be processed in a lab. With the current backlog in the U.S., they can take a week or more to come back. There are a few rapid tests in use that can be processed in minutes, but they can be very inaccurate, said Henry Ji, Sorrento’s co-founder and CEO.
“If you want to combine accuracy and speed, this is the most accurate [rapid] test,” Ji said. There are COVID-19 tests in the market that work in minutes, but the accuracy can vary wildly. “This test from Columbia is fast and accurate.”
Sorrento now is gathering the materials to apply for an emergency use authorization (EUA) for Covi-Trace, said Mark Brunswick, senior vice president of regulatory affairs. Marketing would commence after the FDA gives the green light, although technically it could start as soon as the application is submitted.
“We don’t want to go out there with a test that we think is great, and the FDA says, ‘no way,’ and then we have to stop testing,” Brunswick told BioWorld. “We are in the process of collecting the patient samples; we’ll be running those tests, and we hope to submit the EUA [request] by the middle-of-August, end-of-August time frame while we are gearing up the production of the kits. And when we are geared up, we should have [an answer] back from the FDA as to whether we are good to go or not. But the FDA is on its own time.”
And the test could end up having a relatively low price.
“We are thinking of a price between two and four cups of coffee,” said Brunswick. “We anticipate people being tested before getting into the airport, before you get into the building. Hopefully, hotels would test people coming into the building every day … that is the type of thing we would be anticipating.”
By the time it gets the green light, Sorrento wants to be ready to produce “millions [of tests] per month” and is hoping to move to “tens of millions, if not hundreds of millions,” said Ji. A lot of it depends on production and supply of the enzyme and reacting engines.
While the test will be marketed in the U.S. first, Ji said Sorrento has had “very strong” expressions of interest from other countries.
There are three major considerations that must be addressed to control a disease, said Alexis Nahama, Sorrento’s senior vice president of corporate development. The first is immunization and herd immunity, which is not there at the moment for COVID-19. The second consideration is to avoid contact with spreaders, which is where social distancing comes into play. The third is to “rapidly identify and isolate any infected individual.
“That is the problem today with the current backlog of testing,” said Nahama. “It can take three to nine days to get a result, which means people won’t take special measures until they have a result.
“Speed for the test depends on what you are looking for,” Nahama added. “Half an hour is from the time you say open your mouth and give us some saliva to the time you get a positive or negative result.
“The whole dynamic completely changes if you have the ability to do early identification and isolation,” Nahama told BioWorld.
“In all practical aspects, our job here is to make sure we can manufacture the first million, and after that we have the plan in place to rapidly scale up. Then it will be a government decision about the benefits of such testing,” said Nahama. “We are definitely going to need infrastructure support to massively expand … it is a little bit early to talk about this, but it could come very quickly.”
Sorrento has gone all in into the business of COVID-19 and is working to put in place two programs for each of four areas of prevention, diagnostic, early intervention and rescue therapies.