-- Special approval from German Federal Institute for Drugs and Medical 
      Devices (BfArM) enables home use of a SARS-CoV-2 Rapid Antigen Test using 
      a simple nasal swab 
 
   -- The test will be widely available in pharmacies across Germany 
 
 
   Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced it has been granted special approval by the German Federal 
Institute for Drugs and Medical Devices (BfArM) to offer the SARS-CoV-2 
Rapid Antigen Test using a simple nasal swab for patient self-testing in 
Germany. 
 
   The test is a reliable rapid test for the qualitative detection of a 
specific SARS-CoV-2 antigen in nasal swab samples.This rapid antigen 
test collects the sample from the front area of the nose instead of the 
nasopharynx, resulting in a simplified and more comfortable sampling 
procedure. By following simple instructions, patients can perform the 
test at home with results ready after only 15 minutes. The test will be 
made available in pharmacies and requires no prescription. 
 
   The German Federal Institute for Drugs and Medical Devices' special 
approval of our test provides people in Germany with a reliable option 
to test themselves in the comfort of their own home," said Thomas 
Schinecker, CEO Roche Diagnostics. "Regular self-testing at home can 
reduce pressure on healthcare systems. It can quickly identify people 
with the highest potential to be infectious so they can take immediate 
action to manage their infection, seek medical advice and protect 
others." 
 
   This test is part of a partnership with SD Biosensor Inc., with whom 
Roche has also launched a SARS-CoV-2 Rapid Antibody Test in July and two 
SARS-CoV-2 Rapid Antigen Tests for professional use in September 2020 
and February 2021. Those tests will continue to play an important role 
in this pandemic and remain available for healthcare professional 
testing. 
 
   Roche continues to expand its comprehensive COVID-19 portfolio to 
support healthcare systems in diagnosing SARS-CoV-2 infection. 
 
   About the SARS-CoV-2 Rapid Antigen Test for at-home patient self-testing 
 
   The SARS-CoV-2 Rapid Antigen Test for self testing is a rapid 
chromatographic immunoassay for the qualitative detection of the 
nucleocapsid protein of SARS-CoV-2 present in human nasal specimens. In 
a self-testing clinical study, the SARS-CoV-2 Rapid Antigen Test showed 
a sensitivity of 82.5% and a specificity of 100.0% when compared to 
RT-PCR testing. The relative sensitivity was 91.2% for samples with a 
high viral load ( Ct <=30). Patients suspected of COVID-19 followed 
written and illustrated instructions to sample and test themselves(1) . 
Most study participants considered the procedures easy to perform. 
 
   About antigen testing 
 
   An antigen test detects proteins which are structural or functional 
components of a pathogen and are very specific to that pathogen(2) . 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.(3) 
 
   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(R) 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, 
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(c)/RoActemra(c) (tocilizumab) in COVID-19 pneumonia. On 29 July 
2020 Roche announced that the COVACTA trial did not meet its primary 
endpoint of improved clinical status in patients with COVID-19 
associated pneumonia, or the key secondary endpoint of reduced patient 
mortality. The study was the first global, randomised, double-blind, 
placebo-controlled phase III trial investigating Actemra/RoActemra in 
this setting. Roche remains committed to continuing the 
Actemra/RoActemra clinical trial programme in COVID-19 to further 
explore Actemra/RoActemra in other treatment settings, including in 
combination with an antiviral. In addition to COVACTA, Roche has 
initiated several studies to further investigate Actemra/RoActemra as a 
potential treatment for patients with COVID-19 associated pneumonia, 
including two phase III clinical trials, REMDACTA and EMPACTA, as well 
as the phase II MARIPOSA trial. Roche has further initiated an internal 
early research programme focused on the development of medicines for 
COVID-19 and is engaged in multiple research collaborations. On 19 
August 2020, Roche announced a partnership with Regeneron to develop, 
manufacture and distribute REGN-COV2, Regeneron's investigational 
antiviral antibody combination, to people around the globe. On 18 
October 2020, Roche announced a collaboration with Atea Pharmaceuticals 
to develop a potential oral treatment for COVID-19 patients. 
 
   In these exceptional times, Roche stands together with governments, 
healthcare providers and all those working to overcome the pandemic. 
 
   About SD Biosensor 
 
   SD Biosensor is a global in-vitro diagnostic company focused on the 
development of immunoassay and molecular diagnostic products at the POC. 
Founded in 2010, SD Biosensor has continued to research and develop 
products that can aid in the fast and accurate diagnosis of patients 
across the testing journey. Through these innovative products, they are 
striving to become a leading global in vitro diagnostics company. 
 
 
 
 
 
   For more information, please visit 
https://www.globenewswire.com/Tracker?data=vEueTvGoO6dJVEFx7GveaU76XTiS10wZ5ymuQIEwzXx1k2NNVd05yFwna_JlpAg6R7l_e-rTOn81NbhVnHYeS-K9mbglpA-vRT_Li3fGNzM= 
www.sdbiosensor.com. 
 
 
 
   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 personalised 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 
twelfth consecutive year, Roche has been recognised 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 2020 employed more than 100,000 people worldwide. 
In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 
58.3 billion. Genentech, in the United States, is a wholly owned member 
of the Roche Group. Roche is the majority shareholder in Chugai

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February 26, 2021 12:30 ET (17:30 GMT)