F. Hoffmann-La Roche Ltd: Roche obtains CE mark for the SARS-CoV-2 Antigen Self Test Nasal allowing for rapid self testing of COVID-19 at home

• The SARS-CoV-2 Antigen Self Test Nasal enables individuals to quickly and conveniently test themselves for COVID-19 at home using a simple nasal swab
• An early version of the test has already been available as a home-test in a number of European markets under local special approval pathways since February 2021
• The test will be widely available to individuals through pharmacies and other locations in accordance to local guidelines and testing strategies
• The test works seamlessly with NAVIFY Pass, Roche's digital solution that allows individuals and healthcare providers to immediately store, display, and share their COVID-19 test results and vaccine status through a unique QR code
  

Basel, 08 June 2021 - Roche

The clinical performance of the test was measured by head to head comparison with Roche's highly sensitive reverse transcriptase polymerase chain reaction (RT-PCR) test using nasopharyngeal swab samples as a comparator, the gold standard sampling and detection method for SARS-CoV-2 detection.^1,2 Combined study results showed that the relative sensitivity of the SARS-CoV-2 Antigen Self Test Nasal was 91.1%.** The overall relative specificity was 99.6 %,³ which represents the ability of the test to correctly identify patients without the virus. In one comparative independent self testing study where patients followed written and illustrated instructions to sample, test and read-out the results themselves, the majority of study participants considered the procedures easy to perform.⁴

About antigen testing
An antigen test detects proteins which are structural or functional components of a pathogen and are very specific to that pathogen.⁵ In this case, the test would provide a qualitative "yes/no" answer on the presence of the antigen 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 (nucleocapsid protein) 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 the greatest risk of spreading the infection.⁶

About Roche's response to the COVID-19 pandemic
The COVID-19 pandemic continues to evolve globally with varying developments from country to country and we are partnering with healthcare providers, laboratories, authorities and organisations to help make sure that patients receive the tests, treatment and care they need. This new test is an additional step in Roche's fight against the COVID-19 pandemic, which has already included:

• 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, and
• Ensuring the supply of our existing medicines and diagnostics to patients around the world under exceptional conditions.

Reliable, high-quality testing is essential to help healthcare systems overcome this pandemic. On 13 March 2020 we received FDA Emergency Use Authorization for a high-volume molecular test to detect SARS-CoV-2, the virus that causes COVID-19, which is also available in countries accepting the CE Mark. On 3 May 2020, Roche announced that its COVID-19 antibody test, aimed at detecting the presence of antibodies in the blood, also received FDA Emergency Use Authorization and is available in markets accepting the CE mark. Also in June of last year we received an FDA EUA for the Elecsys IL-6 test to assist in identifying severe inflammatory response in patients with confirmed COVID-19, as well as launching Roche v-TAC, which could help simplify the screening, diagnosis and monitoring of patients with respiratory compromise in the current COVID-19 pandemic. In July of 2020, we added a Rapid Antibody Test, with SD Biosensor as manufacturing partner, to the portfolio that allows the detection of antibodies against COVID-19 at the point of care. In addition, we also launched a Rapid Antigen Test in September and a lab-based Antigen Test in December. Roche is working closely with governments and health authorities around the world, and has significantly increased production to help ensure availability of tests globally.

Roche is actively involved in understanding the potential of the existing portfolio and is researching options for the future. Roche has an ongoing clinical trial program evaluating the role of Actemra©/RoActemra©.

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, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

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. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

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 twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices
[3] SD Biosensor.
[5] European Centre for Disease Prevention and Control. Diagnostic testing and screening for SARS-CoV-2. 2020.
[6] Cerutti, Krüger, van Beek, Igloi, Krüttgen, Salvagno

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