Roche to introduce its next-generation portfolio of SARS-CoV-2
rapid antigen tests (“2.0”) under CE Mark for self-test and
professional use
- Broad and trusted portfolio
of COVID-19 rapid tests feature innovative updates
and enhanced performance, building on insights gained
throughout the pandemic
- All tests now work
seamlessly with navify® Pass,
Roche’s digital solution that allows individuals and healthcare
professionals to immediately store, display, and share COVID-19
vaccination status and test results through a
unique data matrix
- Roche maintains the
capacity to provide tens of millions tests each month to meet
sustained high worldwide demand from individuals and healthcare
professionals
Basel, 12 October 2022- Roche (SIX: RO, ROG; OTCQX: RHHBY) today
announced the launch of its next-generation portfolio SARS-CoV-2
rapid antigen tests (“2.0”) for self-testing and professional use
in countries accepting the CE Mark. Distribution of the new rapid
test portfolio is projected to begin in the coming weeks.
In doing so, Roche builds upon one of the broadest portfolios of
COVID-19 rapid testing solutions with three new test configurations
that feature enhanced performance through the use of an improved
capture antibody and the addition of new digital data sharing
capabilities to all tests. Using nasopharyngeal and nasal swab
samples, respectively, the tests deliver reliable results in as few
as 15 minutes, aiding in the diagnosis of SARS-CoV-2 infection in
individuals with or without symptoms consistent with COVID-19.
“The continued evolution of the SARS-CoV-2 virus and COVID-19
pandemic reinforce the need for individuals and healthcare systems
to have access to the most reliable rapid testing solutions
possible,” said Thomas Schinecker, CEO, Roche Diagnostics. “As a
leader in diagnostic innovation, we are proud to be one of the
first among our industry to apply insights gained from the past two
years toward a next-generation rapid test portfolio. These tests
are ready to support global society as we navigate this next phase
of the pandemic.”
The three tests set to launch are the following:
Professional use:
- SARS-CoV-2 Rapid Antigen Test 2.0
(nasopharyngeal sampling)
- SARS-CoV-2 Rapid Antigen
Test 2.0 Nasal (nasal sampling)
Self-Test:
- SARS-CoV-2 Antigen
Self Test Nasal (nasal
sampling)
Roche maintains the capacity to provide several tens of millions
of each of the tests per month, with the option to quickly build up
additional capacity if needed, to address sustained high worldwide
demand for rapid testing from governments, healthcare systems and
individuals. The next-generation test portfolio will be introduced
in partnership with SD Biosensor Inc., with whom Roche has a global
distribution agreement and previously launched a range of rapid
antigen and antibody tests in more than 50 countries worldwide.
The tests join Roche Diagnostics’s broader COVID-19 portfolio,
which includes a wide range of molecular, serological and digital
solutions that help diagnose and manage COVID-19 during the initial
stages of infection, during the recovery phase, and following the
resolution of infection.
About the next-generation portfolio of SARS-CoV-2 rapid
antigen tests (“2.0”)Lab testing showed that all three
tests can qualitatively detect major variants of concern including
Delta and Omicron variants. Emerging variants are continuously
monitored.
SARS-CoV-2 Rapid Antigen Test
2.01 (nasopharyngeal sampling)The
SARS-CoV-2 Rapid Antigen Test 2.0 is a rapid chromatographic
immunoassay for the qualitative detection of the nucleocapsid
protein of SARS-CoV-2 present in human nasopharyngeal swab samples.
In a prospective clinical studyA , the SARS-CoV-2 Rapid Antigen 2.0
showed a relative sensitivity of 99.00% (95% CI: 94.55 - 99.97%)
and a relative specificity of 99.75% (95% CI: 98.62 - 99.99%). In
total, 100 PCR-positive and 402 PCR-negative subjects participated
in this study. This included 320 asymptomatic subjects, among whom
34 were positive and 286 were negative; and 182 symptomatic
individuals, among whom 66 were positive and 116 were negative.
This test is intended as an aid in the diagnosis of SARS‑CoV‑2
infection in individuals with or without symptoms consistent with
COVID‑19. This product is intended for professional use in
laboratory and near‑patient testing environments. This product is
not intended for self‑testing.
SARS-CoV-2 Rapid Antigen Test 2.0
Nasal2 (nasal sampling)The SARS-CoV-2
Rapid Antigen Test 2.0 Nasal is a rapid chromatographic immunoassay
for the qualitative detection of the nucleocapsid protein of
SARS-CoV-2 present in human nasal swab samples. In prospective
clinical studiesA,B, the SARS-CoV-2 Rapid Antigen 2.0 Nasal showed
a relative sensitivity of 95.80% (95% CI: 91.09 - 98.44%) and a
relative specificity of 100% (95% CI: 99.25 - 100%). In total, 143
PCR-positive and 487 PCR-negative subjects participated in these
studies. This included 320 asymptomatic subjects, among whom 34
were positive and 286 were negative; and 310 symptomatic
individuals, among whom 109 were positive and 201 were negative.
This test is intended as an aid in the diagnosis of SARS‑CoV‑2
infection in individuals with or without symptoms consistent with
COVID‑19. This product is intended for professional use in
laboratory and near‑patient testing environments. This product is
not intended for self‑testing.
SARS-CoV-2 Antigen Self Test
Nasal3The enhanced SARS-CoV-2
Antigen Self Test Nasal is a so-called lateral flow test for the
qualitative detection of SARS-CoV-2 nucleocapsid antigen in human
nasal samples. This test is used to detect antigens of the
SARS-CoV-2 virus in individuals suspected of having COVID-19. It is
designed as a self-test for patients. In prospective clinical
studiesA, B, the SARS-CoV-2 Antigen Self Test Nasal showed a
relative sensitivity of 95.8% (95% CI: 91.09 - 98.44%) and a
relative specificity of 100% (95% CI: 99.25 - 100%). In total, 143
PCR-positive and 487 PCR-negative subjects participated in these
studies. This included 320 asymptomatic subjects, among whom 34
were positive and 286 were negative; and 310 symptomatic
individuals, among whom 109 were positive and 201 were negative.
128 of the subjects were lay-users, sampling and testing themselves
or another lay-user, for example their underaged childrenB.
About antigen
testingAn antigen test detects proteins which are
structural or functional components of a pathogen and are very
specific to that pathogen. 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 by healthcare professionals at the point of care or by
individuals at home. If the target antigen (in this case the
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.2 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.
In general, antigen tests have a high specificity, though are
not as sensitive as molecular tests that amplify the target DNA or
RNA sequence in order to generate a (semi-)quantifiable signal to
indicate the presence of the pathogen in a sample. Therefore, to
make up for the potential decrease in sensitivity of an antigen
test, negative results should be analysed together with additional
information, such as the individual’s exposure history, clinical
symptoms, and additional test results to help guide the diagnosis
and subsequent treatment of the patient.
About Roche’s response to the COVID-19
pandemicAs a leading healthcare company,
we are doing all we can to support countries in their fight against
COVID-19 and minimising its impact. That is why we are working with
governments, policy makers, healthcare professionals and others to
help contain the COVID-19 pandemic and make sure patients continue
to receive the tests, treatment and care they need.
The pandemic has profoundly raised awareness of the role
diagnostics play in COVID-19 diagnosis, treatment development and
disease management. Roche has developed and launched more than 20
COVID-19 diagnostics solutions, including polymerase chain reaction
(PCR) and rapid antigen and antibody tests. Our solutions serve the
entire diagnostic continuum, from high-throughput laboratories to
point-of-care and home self-testing, and cover all currently known
variants. To help meet global demand, we have supplied more than
1.5 billion tests for COVID-19 since March 2020.
Roche continues to evaluate its existing therapeutic portfolio
and is researching future options to help benefit patients with
COVID-19. Our IL-6 inhibitor Actemra®/RoActemra®
(tocilizumab) has been approved for patients hospitalised
with severe COVID-19 in more than 30 countries including the
European Union and is authorised for emergency use in the United
States. The World Health Organization has prequalified Actemra for
use in patients with severe COVID-19, facilitating its availability
in low- and middle-income countries. In addition, we have been
improving access to Actemra by introducing an international
differentiated pricing strategy, providing the medicine at cost for
use in low- and middle-income countries and non asserting patents
in these regions during the pandemic.
We have also been partnering with Regeneron to jointly develop
the antibody combination Ronapreve™ (casirivimab and imdevimab,
known as REGEN-COV™ in the US). It has been approved in multiple
territories including the European Union, Japan, and Switzerland
and authorised for emergency or temporary pandemic use in many
countries including the US. The antibody combination has been made
available to patients in more than 60 countries, across many
geographies including low and middle income countries. As the virus
continues to evolve, we are constantly monitoring Ronapreve’s
activity against emerging variants of concern, and will share
results with health authorities as soon as possible.
Our utmost goal remains to be a trusted partner who acts with
urgency to save and improve the lives of patients with COVID-19 and
to reduce its burden on society. For more information please visit
our COVID-19 response page.
About SD BiosensorSD 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
http://www.sdbiosensor.com.
About Roche Founded in1896 in Basel,
Switzerland, as one of the first industrial manufacturers of
branded medicines, Roche has grown into the world’s largest
biotechnology company and the global leader in in-vitro
diagnostics. The company pursues scientific excellence to discover
and develop medicines and diagnostics for improving and saving the
lives of people around the world. We are a pioneer in personalised
healthcare and want to further transform how healthcare is
delivered to have an even greater impact. To provide the best care
for each person we partner with many stakeholders and combine our
strengths in Diagnostics and Pharma with data insights from the
clinical practice.
In recognizing our endeavor to pursue a long-term perspective in
all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the thirteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
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 www.roche.com.
All trademarks used or mentioned in this release are protected
by law.References[1] SD Biosensor. (2022).
SARS-CoV-2 Rapid Antigen Test 2.0 package insert.[2] SD Biosensor.
(2022). SARS-CoV-2 Rapid Antigen Test 2.0 Nasal package insert.[3]
SD Biosensor. (2022). SARS-CoV-2 Antigen Self Test Nasal package
insert.
A) A prospective study in South Korea, where each study
participant donated three swab samples - one nasal swab and one
nasopharyngeal swab for evaluation on the SARS-CoV-2 Rapid Antigen
Test 2.0 Nasal and SARS-CoV-2 Rapid Antigen Test 2.0 tests, and
another nasopharyngeal swab for evaluation on the RT-PCR comparator
method.
B) A prospective, lay-use study in the United States, where
study participants collected a nasal swab sample and tested
themselves or for another lay-user. Results of the rapid antigen
tests were compared to an RT-PCR comparator method performed on a
mid-turbinate nasal swab sample collected by a healthcare
personnel.
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