COVID-19: An additional contribution to the testing landscape in Canada

LAVAL, QC, June 9, 2020 - The new Elecsys® Anti-SARS-CoV-2 antibody test now available in Canada is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2.

• The high specificity of this test is crucial to determine reliably if a patient has developed antibodies related to an infection with the SARS-CoV-2 virus.

• This serology test has a specificity greater than 99.8% and sensitivity of 99.5% (14 days post-PCR confirmation).

• The Elecsys® Anti-SARS-CoV-2 serology test has the largest clinical studies program with 10,453 samples tested.

• The fully automated test offers a quick turnaround time and is available on all Roche's high throughput cobas e analyzers which are widely available across Canada.

• Roche's extensive global manufacturing capabilities provide tests in the high double-digit millions since last May.

• The tests which are manufactured in Germany and shipped directly to Canada will make a significant contribution in the country.

''We have worked closely with the regulatory authorities to accelerate access to the SARS-CoV-2 serology test in Canada. Laboratory tests are critical to support the Canadian healthcare system in the fight against COVID-19.'' said Andrew Plank, President and General Manager, Roche Diagnostics, division of Hoffmann-La Roche Limited. '' I am proud of the high specificity and sensitivity of the new Elecsys® Anti-SARS-CoV-2 antibody test, which is critically important and brings a reliable tool to better manage the COVID-19 health crisis.''

Mr. Plank added that with this announcement, Roche invites interested parties to participate in its Seroprevalence Study Program where several opportunities can be offered to those who qualify for the program.

Public Health, hospital and private laboratories will be able to run the Elecsys® Anti-SARS-CoV-2 serology test on Roche's cobas e analyzers, which are already widely available across Canada, and in each province. These fully automated systems can provide Anti-SARS-CoV-2 test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.

The Roche's Anti-SARS-CoV-2 test covers a wider span of the immune response against this virus from early on with IgM production to later with IgG with a detection design optimized to bind high affinity antibodies. It has a specificity greater than 99.8% and 99.5% sensitivity1 (14 Days post-PCR confirmation), which can help assess patients' immune response to the virus. Also, the Elecsys® Anti-SARS-CoV-2 serology test has the largest clinical studies program with 10,453 samples tested2. As more is understood about immunity to SARS-CoV-2, this test may help to assess who has potentially developed immunity to the virus.

We are fully committed to further support Canada's fight against COVID-19 with the launch of this new serology test. This test is a complement to our existing molecular cobas® SARS-CoV-2 test, authorized under Health Canada's Interim Order, which detects the novel coronavirus SARS-CoV-2 with our automated, high-throughput cobas 6800/8800 platforms. We also supply other SARS-CoV-2 test solutions that are made available for lower volume testing on the MagNA Pure and LightCycler systems (Research Use Only) and we continue to work on expanding our portfolio of COVID-19 test solutions.

Patterns of typical abnormalities in routine laboratory testing have been identified in case series of hospitalized COVID-19 patients, which have been associated with poor clinical outcomes. Through our broad clinical biochemistry menu, we provide biomarkers such as D-Dimer, glucose, Interleukin-6 (IL-6), procalcitonin (PCT), lactate dehydrogenase (LDH) and C-reactive protein (CRP). These biomarkers can help clinicians decide when more aggressive critical care support must be considered or on the contrary when stepping down of treatment may be an appropriate course of action.

In addition to testing, creative ideas have emerged with the collaboration of the community and industry partners. With the COVID-19 Open Innovation Challenge, we called the innovative minds in Canada to bring forward solutions to address the crisis, and with the support of the SCALE AI Supercluster, we are working with IVADO Labs on optimizing the distribution of diagnostic tests for COVID-19 with an AI-powered allocation optimization tool. We also believe that an important way in which we can win this fight is through the sharing of knowledge and healthcare data to better inform patient care and health system decision making. With the Roche Data Science Coalition, we aim to bring actionable COVID-19 intelligence to patients, frontline healthcare providers, institutions, supply chains, and governments.

With a majority of medical decisions being based on lab results, the importance of diagnostics testing within the healthcare system that exists under normal circumstances has been further reinforced during the pandemic.

It has also generated better collaboration between the private and public healthcare stakeholders and a faster adoption of new technologies for the benefit of the patient.

An antibody test, also called a serology test, is used to determine whether a person might have gained immunity against a pathogen or not. The human body makes antibodies in response to many illnesses. In the current situation of the COVID-19 pandemic, antibody tests need to be able to specifically detect antibodies against SARS-CoV-2 with no cross-reactivity to other similar coronaviruses, which could generate a false positive result and thus wrongly indicate potential immunity. A false positive result happens when a person receives a positive test result, when they should have received a negative result. False positives are particularly critical when we do not know how many people in a given population have been exposed to the virus. As of 24 April 2020, no study has evaluated whether the presence of antibodies to SARS-CoV-2 confers immunity to subsequent infection by this virus in humans3.

Elecsys® Anti-SARS-CoV-2 is an immunoassay for the in-vitro qualitative detection of antibodies (including IgG) to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum and plasma. Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 10,453 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.80% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys® Anti-SARS-CoV-2 detected antibodies with 99.5% sensitivity in samples taken 14 days after a PCR-confirmed infection. The importance of specificity and sensitivity of a particular test will be dependent on its purpose and disease prevalence within a given population.

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.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognized as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

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References:

1. Full specifications of Roche's Elecsys® Anti-SARS-CoV-2 antibody test and immunoassay systems, including throughput, can be found on our diagnostics.roche website

2. For more information, please refer to Package insert of Elecsys Anti-SARS-CoV-2

4. For more information, please refer to Package insert of Elecsys Anti-SARS-CoV-2

SOURCE Roche Diagnostics

For further information: Roche Diagnostics Canada, Tel: (450) 686-3138