Rapid detection of COVID-19 and its variants: Nicoya develops innovative saliva test kit

07-May-2021 - Last updated on 07-May-2021 at 15:10 GMT

Atlas rapid saliva test kit © Nicoya Life Sciences

Ontario-based, Nicoya Lifesciences, is in the process of completing a prototype of a low-cost, single-use device that tests for active SARS-CoV-2 infection, variants and, eventually, other viruses. The novel test is called Atlas.

Users administer the Atlas test themselves with a simple saliva collection kit. After that, a smartphone application provides results, in only 20 minutes – without complex lab equipment or highly trained technicians.

Atlas was developed with funding from the National Research Council of Canada (NRC) as part of a joint challenge issued with the Public Health Agency of Canada (PHAC) through the government’s Innovative Solutions Canada (ISC) program.

Product development

Ryan Denomme, Nicoya’s CEO, told us about the background to the development of the innovative test.

nicoya prod dev — Product development at Nicoya Lifesciences © Nicoya Lifesciences

“This all started around this time last year. The government of Canada put out a call to industry for the development of a new type of diagnostic technology.”

He said that move was spurred on by the lack of testing capacity that not only Canada, but many other countries, were facing at that point.

“Testing at that stage was being done in central labs with the turnaround time from swab to result taking around 3-5 days, if not longer.”

The Canadian government, as many other countries have done, identified that that central lab model was not exactly ideal for managing outbreaks of something as infectious as SARS-CoV-2 so they wanted to develop some new technologies that would enable rapid turnaround time – 20 mins from sampling to test result - but with the same level of sensitivity and specificity as you would get from a traditional PCR test in a lab, explained Denomme.

“So a lot of requirements, needing new approaches and new technologies: they funded four companies in phase one to a total value of $300K. We were one of those; we demonstrated proof of concept of our novel approach that we call Atlas and showed it would be applicable for meeting the requirements of the challenge they had set. Evaluating further results a couple of months later, they really liked what we had achieved, and they funded us for the next stage - phase two: we were awarded a grant of about $2m to go from proof of concept to the prototype stage. We are currently in the process of developing that prototype now. It will be ready soon.”

Along with the capital, Nicoya is getting access to expertise including support from Canada’s Industrial Research Assistance Program (IRAP), an organization that has a lot of experience in developing such technology, he said.

Nicoya Lifesciences has a long history of developing and commercializing biosensor technology, which is typically used in the R&D domain to help scientists to understand diseases and develop new drugs to treat those diseases.

“Fundamentally, although there are used in the R&D space, a lot of the core biosensing technologies that are in those products are very applicable to diagnostics. That being said, we did have to make quite a few innovations on top of that core base of technologies that we have in order to develop Atlas. One of the big ones was miniaturizing the technology, to get it into a format that could be hand held and easily distributed to a large number of places outside of the central labs. So miniaturization was a big part of the technology development as well as producing a test that was sensitive enough to be able to be read with the naked eye or through a cell phone camera: we had to create a number of novel readout chemistries in order to actually meet those requirements,” explained the CEO.

Sensitivity of the kit

How does the Atlas device compare to existing saliva-based testing kits?

“One of the major drawbacks of most rapid saliva tests on the market is that the sensitivity values are not as good as a central lab test – this means they can end up missing people who are early on in their infectivity cycle, so they might have the virus, and they might be able to spread it, but they don’t have a high enough level of viral load to be detected by the rapid tests, that is a big area. The other drawback is around the specificity of the rapid tests, where, a lot of the time, you get false positives, the negative social impacts of which can be enormous. So ensuring you have tests that are performing at the highest specificity and sensitivity possible is really important,” remarked Denomme.

One of the key technology platforms that drives the performance of Atlas is digital microfluidics (DMF); it allows the company to undertake a large number of fairly complex assay steps that would typically be done in a lab by trained technicians. “We can miniaturize and automate all of that and put it into a handheld device so you can get lab quality results from a rapid test - that is one of the main innovations in the product, and it enables that much higher level of specificity and sensitivity.”

He said that, just by manipulating the antibodies in the test, it can be made applicable for the detection of a range of different types of viruses and biomarkers.

Clinical testing

The company plans to start clinical testing in the next 4-6 months, as the necessary number of prototypes are built. “After the clinical study is complete, and assuming everything goes well, we expect to start offering the product more broadly.”

The clinical study will be used as data to support applications with Health Canada and the US Food and Drug Administration (FDA). “By the end of this year, we would hope to have it available commercially.”