-- 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)