Roche receives U.S. FDA Emergency Use Authorization for its high-throughput test to detect monkeypox virus
2022年11月16日 - 3:00PM
Roche receives U.S. FDA Emergency Use Authorization for its
high-throughput test to detect monkeypox virus
- In May 2022, Roche was one of the first companies to
develop a suite of tests to detect the
monkeypox virus and aid in the
understanding of why and how the disease is
spreading.
- cobas MPXV for use on
cobas 6800/8800 Systems is the
first monkeypox virus test
granted EUA following evaluation in actual patient samples rather
than just samples formulated in the laboratory.
- High-throughput solutions enable rapid results,
allowing individuals to avoid additional testing or unnecessary
isolation, and supporting access to appropriate treatment as soon
as possible.
Basel, 16 November 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today that the U.S. Food and Drug Administration (FDA)
granted Emergency Use Authorization (EUA) for cobas® MPXV for use
on the cobas® 6800/8800 Systems. The test is a real time PCR test
for the qualitative detection of DNA from monkeypox virus (MPXV) in
lesion swabs collected from individuals suspected of monkeypox
infection by their healthcare provider.
cobas MPXV targets two different regions of the MPXV genome,
which are both less prone to mutations than other parts of the
genome. This dual-target approach ensures that cobas MPXV will
continue to detect the virus even if a mutation occurs in one of
the target regions.
“When multiple clusters of monkeypox virus infection were
initially reported in countries where the disease is not endemic,
Roche was among the first companies to address virus concerns with
test kits,” said Thomas Schinecker, CEO of Roche Diagnostics. "In
order to meet the testing needs and workflow demands of
laboratories as well as expand access to safe and reliable
diagnostic solutions, we developed the cobas MPXV on the fully
automated and high-throughput cobas 6800/8800 system."
The high-throughput solution can help individuals get the right
results quickly. This is important so that patients are not
subjected to unnecessary additional testing or isolation, and will
have access to appropriate treatment as soon as possible.
Like many viruses, monkeypox cannot be conclusively diagnosed by
symptoms alone. This is because many monkeypox symptoms closely
resemble those of other rash-producing illnesses such as
chickenpox, measles, bacterial skin infections, and even hives or
allergies.
For more information on the test kits launched for researchers
that were launched in May 2022 please follow this link: Roche
develops unique PCR tests to detect the monkeypox virus.
About the test cobas® MPXV is intended for use
for the qualitative detection of DNA from monkeypox virus in
individuals suspected of monkeypox infection by their healthcare
provider. cobas MPXV for use on cobas 6800/8800 Systems is the
first monkeypox virus test granted EUA following evaluation in
actual patient samples rather than just samples formulated in the
laboratory. The assay uses β-globin, a target present in human DNA,
as an endogenous control to ensure specimen adequacy. Unlike the
previously cleared assay, cobas MPXV detects monkeypox nucleic
acids and the endogenous control in the same well, improving
laboratory efficiency by effectively doubling the number of
clinical samples a laboratory can assess on each plate and halving
reagent needs per sample.
cobas MPXV is only for use under the FDA’s EUA in laboratories
certified under Clinical Laboratory Improvement Amendments that
meet requirements to perform high or moderate complexity tests.
Laboratories within the United States and its territories are
required to report all results to the appropriate public health
authorities. cobas MPXV is intended for use by qualified clinical
laboratory personnel specifically instructed and trained in the
techniques of real-time PCR and on the use of the cobas 6800/8800
Systems.
About the cobas
6800/8800 SystemsThe Roche cobas 6800/8800 Systems
provide results in three and half hours and offer improved
operating efficiency, flexibility and fastest time-to-results with
the highest throughput providing up to 96 results in about three
hours and a total of 1,440 results for the cobas 6800 System and
4,128 results for the cobas 8800 System in 24 hours.
About monkeypoxSymptoms of
monkeypox include fever, chills, headaches, muscle aches, fatigue,
swollen lymph nodes and a painful rash that characteristically
appears as raised bumps on the skin and tends to be distributed on
the face, extremities and genitals. As the disease progresses,
these bumps fill with pus and fluid and become umbilicated. They
will eventually ulcerate, scab and fall off.
About RocheFounded in 1896 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 recognising 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.
Roche Group Media RelationsPhone: +41 61 688
8888 / e-mail: media.relations@roche.com
Hans Trees, PhDPhone: +41 79 407
72 58 |
Nathalie AltermattPhone: +41 79
771 05 25 |
Karsten KleinePhone: +41 79 461
86 83 |
Nina MählitzPhone: +41 79 327 54
74 |
Dr.
Barbara von SchnurbeinPhone: +41 79 699 97 44 |
Sileia Urech Phone: +41 79 935 81
48 |
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