NEWS DETAIL

Supporting Canada's Back to Normal: Roche Diagnostics Canada Introduces the New SARS-CoV-2 Rapid Antigen Test Nasal Approved Under Health Canada's Interim Order

  • The SARS-CoV-2 Rapid Antigen Test Nasal uses a nasal swab to quickly and conveniently collect specimens from people suspected of having an active infection
  • The easy-to-use test optimizes workflow and does not require an instrument or any preparation
  • Nasal sampling allows for collection of the sample from the front area of the nose resulting in a less invasive testing experience by reducing overall patient discomfort, particularly in sensitive individuals such as children
  • Antigen test reliably and quickly identifies people suspected of COVID-19*, with results ready in 15 minutes, allowing informed decisions including rapid isolation
  • The SARS-CoV-2 Rapid Antigen Test Nasal is intended for use by healthcare professionals, or for self-collection under the supervision of a healthcare professional.

LAVAL, QC, June 30, 2021 /CNW Telbec/ - A few weeks after announcing the availability of its Elecsys® Anti-SARS-CoV-2-S (spike protein) antibody test, Roche Diagnostics, a division of Hoffmann-La Roche Limited, is pleased to announce that its SARS-CoV-2 Rapid Antigen Test Nasal, commercialized under a Global partnership with SD Biosensor Inc., has received approval under Health Canada's Interim Order, increasing Roche's contribution to the fight against the pandemic.

In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test already available in Canada, the newly approved SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose resulting in a simplified and faster testing procedure.1 This testing method can help reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities.

"We are very proud of this announcement that showcases once again our commitment in the fight against COVID-19. While we can only commend the progress made by many jurisdictions in making rapid tests widely available, we remain convinced that the country has not yet leveraged their full potential, said François Drolet, Executive Director, Public Affairs at Roche Diagnostics. Rapid testing can play an important role in the fight against COVID-19, especially in places where laboratory testing is not available and quick results are needed, such as nursing homes, workplaces, schools and other congregate settings. In addition, our SARS-CoV-2 Rapid Antigen Test Nasal offers a more comfortable testing experience."

"While vaccination rates continue to improve, Canada has a long way to go before we reach true herd immunity. Rapid testing helps us bridge the gap with greater safety, protecting the lives of workers and the livelihoods of small business owners. The business community plays a leading role in the fight against COVID-19, exemplified by today's announcement from our member Roche Diagnostics about their new, easy-to-use COVID test that doesn't require a laboratory confirmation. This new test can be of enormous benefit for businesses wanting to keep employees and customers safe in real time, and we congratulate Roche on their innovation," said Perrin Beatty, President and CEO, Canadian Chamber of Commerce.

Additionally, Charles Milliard, President and CEO of the Fédération des chambres de commerce du Québec (FCCQ) said that "despite the progress in vaccination and the decreasing cases of infection, many businesses and organizations are still worried about their future. They constantly show us their interest in having access to all the means available to accelerate the economic recovery, and the identification of an infection through rapid tests is an additional tool in the fight against the pandemic that can undoubtedly help to reduce the risk of outbreaks at workplaces and thus ensure the stability and functioning of their operations."

Did you know?

In January 2021, the COVID-19 Testing and Screening Expert Advisory Panel identified four priority areas for action published in their report titled "Priority strategies to optimize testing and screening for COVID-19 in Canada"2 including the deployment of rapid tests for screening. Based on modelling3, the report stated that the effectiveness of screening depends more on testing frequency and turnaround time than on a test's ability to identify individuals with the virus. This means that a screening strategy that relies on rapid tests may be superior to a screening strategy that relies only on lab-based PCR.

Furthermore, the Industry Advisory Roundtable on COVID-19 Testing, Screening, Tracing and Data Management released a report4 that reiterates the importance of using rapid tests in workplace settings since rapid detection helps with the quick isolation of positive COVID-19 cases to keep the rest of the workplace safe and support economic recovery.

Rapid testing is also supported by Medtech Canada and members of the industry including Roche Diagnostics Canada in a position paper that highlights a series of recommendations calling for comprehensive testing strategies in Canada, including the deployment of rapid antigen tests and urging provincial governments to fully use all available tools in testing in order to help Canadians go back to a more normal life, restart Canada's economy, and save lives.

"The perfect test does not exist, nor does the perfect strategy, but rapid antigen tests are optimal for large scale testing since they are easy to use by a wide range of healthcare professionals and can be brought directly to the public in order to reduce the propagation of the virus" said Michele D'Elia, Executive Director, Medical and Scientific Affairs at Roche Diagnostics. "It is important to remember that not all infected individuals go to testing sites since severity of symptoms is variable, thus increasing the risks of transmission. Bringing the rapid tests to, for example, schools and workplaces, can significantly help to isolate positive cases without delays."

The SARS-CoV-2 Rapid Antigen Test Nasal is the latest addition to Roche Diagnostics Canada's comprehensive portfolio to help healthcare systems combat COVID-19 through testing in the laboratory and at the point-of-care. The company praises the efforts of healthcare providers and frontline workers in communities all around Canada.

About Roche's response to the COVID-19 pandemic

As a leading healthcare company, we are committed to minimize the impact of COVID-19 and help save and improve lives. Roche's fight against the pandemic includes:

  • Launching COVID-19 diagnostic tests for active infection and the detection of antibodies in patients who have been exposed to the virus
  • Investigating treatments from our existing portfolio to better understand their potential to treat patients with COVID-19
  • Increasing manufacturing and supply chain capacity to meet product demand across our portfolio within the wider context of COVID-19 treatment
  • Ensuring the supply of our existing medicines and diagnostics to patients under exceptional conditions.

About the SARS-CoV-2 Rapid Antigen Test Nasal

The SARS-CoV-2 Rapid Antigen Test Nasal is a rapid chromatographic immunoassay for the qualitative detection of the nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In clinical studies, the SARS-CoV-2 Rapid Antigen Test Nasal showed a relative sensitivity of 89.6% (Ct value ≤ 30; 95% CI: 79.7% - 95.7%) and a specificity of 99.1% for professionally collected samples. For self-collected samples** a sensitivity of 89.1% (Ct value ≤ 30; 95% CI: 78.8% - 95.5%) and a specificity of 99.0% was detected. Overall, the studies contained 696 symptomatic and asymptomatic individuals.5 This test is intended to detect antigen from SARS–CoV–2 in individuals suspected of COVID–19 with clinical symptoms onset within 5 days.

About antigen testing

An antigen test detects proteins which are structural or functional components of a pathogen and are thus very specific to that pathogen.6 In this case, the test would provide a qualitative "yes/no" answer on the presence of the pathogen in the patient sample and can be offered as a rapid strip test that is performed at the point of care. If the target antigen is present in sufficient concentrations in the sample, it will bind to specific antibodies and generate a visually detectable signal on the test strip, typically with results ready in 15 minutes. A rapid antigen test can reliably detect individuals with a high viral load allowing healthcare professionals to quickly identify those patients at greatest risk of spreading the infection.7

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. For more information, please visit www.rochecanada.com and www.roche.com.

About SD Biosensor

SD Biosensor is a global bio-diagnostic company that provides in vitro products engrafted with innovative technologies. Established in 2010, SD Biosensor has successfully launched diagnostics of blood glucose, glycated hemoglobin and cholesterols globally. Through these innovative products, they are striving to become a leading global in vitro diagnostic company. For more information, please visit www.sdbiosensor.com.

References

[1] OASH Nasal Specimen Collection Fact Sheet - Updates 2020-11-11

[2] https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing-screening-advisory-panel/reports-summaries/priority-strategies.html#a9

[3] https://advances.sciencemag.org/content/7/1/eabd5393

[4] https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing-outreach-collaboration/industry-advisory-roundtable/reports/task-shifting-self-administration-workplace-screening-programs.html#a2

[5] SD Biosensor. (2021). SARS-CoV-2 Rapid Antigen Test Nasal Canadian package insert

[6] European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020.

[7] Cerutti, Krüger, van Beek, Igloi, Krüttgen, Salvagno

*Within the first 5 days of the onset of symptoms.

**Done under the supervision of a healthcare professional

All trademarks used or mentioned in this release are protected by law.

SOURCE Roche Diagnostics Canada

For further information: Marie-Élaine Guay, Roche Diagnostics Canada, E: [email protected]

Related Links

https://www.rochecanada.com/