With the highly transmissible Omicron variant resulting in thousands of new daily COVID-19 cases in Canada, the arduous quest of trying to secure reliable access to Covid rapid tests, antigen, is one that has ramped up in recent days.
However, despite a rise in Canadian companies manufacturing personal protective equipment throughout the pandemic, the number of domestic companies approved to sell rapid test kits remains low.
As of Jan. 6, Artron Laboratories Inc. in Burnaby, B.C. is just one of two Canadian companies authorized by Health Canada to sell and produce the highly sought rapid antigen tests (the other is BTNX in Markham, Ont.).
Several other companies from across the world are authorized to sell the devices in the country, but like the domestic competitors, global demand for the tests — including from governments in Canada — can pose challenges when it comes to local supply.
In Ontario, there have been multiple reports of people waiting in lines for hours to try to get test kits dispensed by the provincial government.
However, on Wednesday, the federal government announced 140 million rapid tests from a variety of providers would be distributed to provincial and territorial governments on a per capita basis.
In the case of Artron, the company’s manager of scientific and regulatory affairs said the process of getting Health Canada approval to sell the kits for professional settings has been an intensive process.
“It’s not just that you develop a test in the lab and you bring it right to the market. There are a lot of studies that go into it before you can bring it,” Dr. Uma Gaur told CityNews.
“There were no weekends for us. I mean we were working weekdays, weekends. Whenever we were getting a response from Health Canada … they need a response within 10 days … we were working around the clock.”
“There were times when our team we were working for these regulatory submissions until 4:30 in the morning. We used to start at 8 a.m. and we used to go through the whole day until 4:30 or 5 a.m. the next day, and that has been quite often,” she said.
To understand the timelines associated with regulatory approval, it was in March, 2020 — around two months of the first COVID-19 patient was confirmed in Canada — when Gaur said the company came up with a prototype antibody test. The application was submitted to Health Canada in June of that year and they received the go-ahead in April.
When they came up with the prototype antigen test in July 2020, she said the research and development department had to keep working to refine it and respond to ever-changing specifications and demands by Health Canada and the U.S. Food and Drug Administration. It wasn’t until October 2021 when it got approved for professional use.
The company now has multiple types of tests on the market that are comparable with competitors, including nasopharyngeal (the swap that goes further into the skull and in laboratory testing achieved a 97 per cent sensitivity result) as well as nasal swab (the shorter one that is included in most test kits, which in laboratory testing achieved a 91 per cent sensitivity result).
As for when the tests could hit pharmacies as an off-the-shelf purchase, Gaur said it could be as soon as the end of January or early February. She said the submission for this particular approval has been delayed due to revised Health Canada and FDA guidelines that called for more clinical data on a certain age group of children to verify it is “safe and sensitive.”
When it comes to the company’s work on COVID-19 tests, Cenk Ozkan, Artron’s vice-president, said throughout most of the pandemic the company has been working with foreign governments. He said the earliest testing project occurred at Egyptian airports.
“It’s 9 a.m. somewhere,” he said, referring to how he and salespeople with the company — even during New Year’s — have had conference calls with bureaucrats in governments across the world throughout the course of the pandemic.
“I honestly don’t remember the last time I had an uninterrupted eight hours of sleep in the last two years. We pretty much get in sleep here and there.”
However, with the recent approvals in Canada, he said they’re halting further inquiries from across the world to respond to what’s being asked for domestically.
He said the company recently won part of a tender to provide kits to the federal government as well as the Canadian Armed Forces, which has led the procurement process of major COVID-19 supplies such as vaccines on behalf of the provinces. However, Ozkan said staff are trying to find a way to provide access to provincial governments and emergency services agencies at the local and regional levels.
The company’s latest challenge involves continuing to scale-up its west coast production facilities, which are largely in place already with the needed biochemical reagents. Artron currently produces rapid test kits for other infectious diseases as well as for fertility, so Ozkan said they have all the critical components needed for the COVID-19 tests and work is temporarily being scaled back on the other devices.
However, recent extreme weather events, the holidays and rising COVID-19 case spread have partially impacted the ability to bolster their output. Ozkan didn’t give a specific number, but said the company is able to produce “tens of millions” of tests.
Gaur and Ozkan said staff continue to monitor for new COVID-19 variants and are prepared to make adjustments should any be needed. But heading into 2022, both said the work to date has been profoundly meaningful to themselves and others.
“As a scientist, all that you want is whatever science you are doing should help people … people should be able to use it. You can see the change it brings to someone’s life,” Gaur said.
“I’ve been working in this industry for over 10 years now and this is the most prideful that I was ever in this line of work. Being able to answer the demand and being able to help people with the diagnosis efforts … it feels great,” Ozkan added.