Working to source diagnostic solutions for COVID‑19

- Ottawa, Ontario

Since the onset of COVID‑19, the National Research Council of Canada (NRC) has been working with and supporting companies to deliver revolutionary technologies to Canada's public health agencies. In particular, the NRC has played a large role in supporting Canada's efforts to identify secure and reliable COVID‑19 diagnostic and monitoring tests—a vital tool for disease management and enabling the safe return of Canadians to the workplace and classroom.

Putting the team together

At the onset of the pandemic, the NRC quickly assembled its experts to respond to Canada's emerging needs. Through its network of industrial technology advisors and via its website, the NRC invited Canadian companies to share overviews of their COVID‑19 technologies and solutions—an exercise that yielded a broad range of leads in the diagnostics and testing-related fields alone. In response, the NRC Industrial Research Assistance Program (NRC IRAP) created a Diagnostic Subject Expert Team (SET) to work with Canadian companies in this space to assess their existing capabilities, review proposed solutions, and identify candidates with the best potential to meet Canada's short-, medium- and long-term diagnostic and monitoring needs.

The efforts of NRC IRAP's Diagnostics SET have been far-reaching. The team worked with Canadian diagnostics companies, providing them with advice and support to overcome technical and regulatory hurdles, adapt manufacturing processes, and source the necessary expertise and materials to advance research and development (R&D) and scale up production. In addition to supporting eligible firms with NRC IRAP advisory services and R&D funding, the team also played a vital role in connecting high-potential candidates with other government partners, funding streams and COVID‑19 response programs.

Company spotlight – LuminUltra

LuminUltra of Fredericton, New Brunswick, is recognized globally as a leader in the development of molecular biology-based tests and reagents for environmental, industrial and diagnostic monitoring. When the COVID‑19 pandemic hit, the company quickly responded by expanding its capabilities to produce various aspects of diagnostic kits to meet both Canadian and international public health care needs.

NRC IRAP joined forces with the Atlantic Canada Opportunities Agency (ACOA) and NGen—Canada's manufacturing supercluster— to support LuminUltra in developing its COVID‑19 test kits. This support enabled the company to scale up its manufacturing processes by adding automated robotic lines, doubling its number of employees and creating a new facility for test kit manufacturing to meet Health Canada regulations. Along the way, NRC IRAP's Diagnostics SET worked with LuminUltra to enhance their healthy supply chain with more Canadian-made materials that are readily available and less subject to the risk of delays or supply line disruptions associated with importing materials.

In a short period of time, LuminUltra developed Health Canada approved clinical tests for COVID-19 along with COVID-19 environmental and waste water test kits that are being used to detect and monitor for the virus in long term care facilities, office buildings, factories, airports, ships and other locations. The company is producing millions of COVID-19 test kits every week for Canada and to assist other countries in combating the COVID-19 pandemic.

Issuing a challenge to industry

In April 2020, the NRC issued a COVID‑19 diagnostics challenge in partnership with the Public Health Agency of Canada (PHAC) through Innovative Solutions Canada, a federal program that helps Canadian innovators solve real-world problems by funding R&D and testing prototypes in real-life settings. Four proposals received Phase I funding from NRC IRAP totaling $1.2 million to prove the feasibility of their solution for a rapid, single-use testing kit that will diagnose individuals affected by COVID‑19 within 3 days of the start of their symptoms using a sample other than a nasopharyngeal swab. Successful projects moving into Phase II have been approved and will receive further funding to develop a prototype of their proposed solution.

Company spotlight – Diagnostics Biochem Canada

For more than 45 years, Diagnostics Biochem Canada's (DBC) mission has been to develop and market unique immunoassay kits for diagnostics in health care. With this experience, the company was well‑positioned to join Canada's COVID‑19 testing efforts.

DBC is producing blood‑based tests that will measure antibodies to the SARS‑CoV‑2 virus‑a vital tool in understanding the population's exposure to the virus and to inform decisions on issues like whether individuals can return to work. Over the longer term, this test could also play an important role in understanding the efficacy of a COVID‑19 vaccine by measuring immune response post‑inoculation.

In addition, the firm is developing a second test that can be used as a point‑of‑care sampling method where a drop of blood from a simple finger‑prick is collected on a card, dried, and mailed to the testing lab to detect COVID‑19.

DBC's blood test is unique in that it measures 3 classes of antibodies - IgA, IgM and the IgG‑to increase testing accuracy. The test is a lab-based test, and is jointly funded by NRC IRAP and Canada's Department of National Defence. Along the way, NRC IRAP has provided the firm with referrals to potential partners such as Innovation, Science and Economic Development Canada, NGen (Canada's manufacturing supercluster), Canadian Blood Services, and Health Canada.

The NRC has also helped the firm navigate the regulatory environment as it submitted its lab‑based antibody test for Health Canada approval. DBC's IgG kit and Total Antibody kit have received Health Canada approval and can now be used in the health care industry and by health care providers.

Working with the NRC's Pandemic Response Challenge Program

The NRC is not only focussed on helping companies with near-term COVID‑19 diagnostics solutions; it is investing in novel diagnostic technologies to meet emerging and anticipated public health needs. The NRC's Pandemic Response Challenge Program recently issued a call for collaborators to help the NRC develop a novel diagnostic test to rapidly detect the presence of COVID‑19, or a component of the virus, in saliva samples without the use of traditional reagents or reading instruments. Such a device could facilitate point-of-care diagnosis beyond traditional clinical settings such as the workplace, schools or at home. The program sought research partners from academia and industry to contribute molecular assay solutions that can be integrated with the NRC's technologies and manufactured at scale. As a result, the NRC is working with 4 partners to co-develop this technology. Outside of the context of this challenge, NRC IRAP continues to support a number of Canadian businesses developing saliva-based tests.

Company spotlight – Precision Biomonitoring

Precision Biomonitoring, based in Guelph, Ontario, is an industry leader in developing onsite DNA detection tools for applications when you need to know now. Its initial focus was on environmental monitoring to identify aquatic and terrestrial organisms, and expanded to surveillance of pathogens in food, farm animals and crops. The company became an early partner in the Government of Canada's plan to mobilize industry in the fight against COVID‑19. NRC IRAP and Precision Biomonitoring have been in discussion on many different opportunities to fund their COVID‑19 diagnostic test kit since the beginning of the pandemic.

In March and April 2020, NRC IRAP and the NRC's Human Health Therapeutics Research Centre assisted the firm with identifying Canadian partners who could support them in developing and scaling up their technology, including manufacturers of lyophilized reagents needed for the test strips. NRC IRAP also provided the firm with guidance and connections to enable project funding from other major players such as NGen, Canada's manufacturing supercluster. In addition, NRC IRAP's industrial technology advisors provided several advisory sessions to help the firm navigate Health Canada requirements when they were submitting their COVID‑19 test for approval.

The firm is now producing Health Canada approved SARS‑CoV‑2 TripleLock™ Test Strips designed to detect multiple targets of the virus. Paired with a battery‑operated, ultra‑portable diagnostic device, the strips are capable of analyzing 9 samples at a time, and provide results in only 60 minutes.

The firm is also producing Health Canada approved SARS-CoV-2 TripleLock™ lyophilized 96-well microplates for labs. With funding from NGen, the company has optimized its production capacity to 1,000,000 tests per week. Precision Biomonitoring is now able to provide Canada and other countries with a shelf-stable, point of care test and lab microplates, made in Canada for COVID-19.

Connecting supply chains and testing for the future

Working to secure Canada's COVID‑19 testing capacity has not been without its challenges. Traditionally, Canada has relied on import to source enzymes, chemicals or testing components. In the context of a global pandemic, where all countries are looking for the same materials, the supply chain becomes unreliable. NRC IRAP and the NRC's research centres have been working with other government departments, academia and manufacturers to secure Canada's diagnostics supply chain—from the provision of reagents, to swabs and other components needed for test kits.

As Canada reopens its economy and more Canadians look to resume pre-pandemic activities, delivering safe and reliable COVID‑19 testing and monitoring remains a high priority for the NRC and the Government of Canada. With dozens of Canadian companies benefitting from the NRC's support, great strides are being made in furthering their diagnostic technologies, bringing us one step closer to overcoming the COVID‑19 pandemic.