Test will now be available for qualified laboratories across
the European Union
Company provides update on other designated approvals
received to date
WALTHAM, Massachusetts,
March 26, 2020 /PRNewswire/ -- Thermo
Fisher Scientific Inc. (NYSE:TMO), the world leader in serving
science, today announced that it has received the CE mark in the
European Union for its diagnostic test to detect nucleic acid from
SARS-CoV-2, the virus that causes COVID-19.
"The CE mark certification is an important step in combatting
the outbreak of COVID-19 across Europe," said Marc N.
Casper, chairman, president and chief executive officer of
Thermo Fisher Scientific. "We are committed to fighting this
disease and we will continue to work with regulatory authorities
and customers around the world to expand the availability of
diagnostic testing and stem the spread of the coronavirus."
The Thermo Fisher test, which uses Applied Biosystems TaqPath
Assay and real-time PCR technology, is designed to provide patient
results within four hours of a sample being received by a lab. The
estimated time-to-result also includes time for sample preparation
and instrument analysis.
This CE mark represents Thermo Fisher's assurance that its test
complies with the European Union's In vitro Diagnostic
Directive, which applies to products that are manufactured in or
designed to be sold in the European Economic Area1.
For more information about the CE-marked test, visit
www.thermofisher.com/covid19ceivd
Update on Other Designated Approvals
Thermo Fisher
Scientific received Emergency Use Authorization by the U.S. Food
and Drug Administration for its COVID-19 test on March 13, 2020. This authorization was amended on
March 24, 2020, to include
additional instruments, such as the company's Applied Biosystems
7500 Fast Real-Time PCR System. This expands testing
capabilities in the U.S. from approximately 1,000 instruments to
more than 3,000 instruments on which Thermo Fisher's diagnostic
test can be run. The expansion also includes manual sample
extraction using the MagMax Viral/Pathogen Nucleic Acid Isolation
Kit as well as Applied Biosystems COVID-19 Interpretive
Software.
In addition to receiving the designated approvals in the U.S.
and E.U., Thermo Fisher's diagnostic test has received the
designated approvals in Canada,
Singapore, India, Australia and New
Zealand.
Thermo Fisher has created an online resource to make it easier
to find up-to-date information about its response to the COVID-19
pandemic, including availability of its diagnostic test kits.
Please refer to
https://corporate.thermofisher.com/en/COVID-19.html for
current news, information and frequently asked questions about
COVID-19-related products and services that are vital to
researchers, labs, healthcare workers and first responders
worldwide.
About Thermo Fisher Scientific
Thermo Fisher
Scientific Inc. is the world leader in serving science, with annual
revenue exceeding $25 billion. Our
Mission is to enable our customers to make the world healthier,
cleaner and safer. Whether our customers are accelerating life
sciences research, solving complex analytical challenges, improving
patient diagnostics and therapies or increasing productivity in
their laboratories, we are here to support them. Our global team of
more than 75,000 colleagues delivers an unrivaled combination of
innovative technologies, purchasing convenience and pharmaceutical
services through our industry-leading brands, including Thermo
Scientific, Applied Biosystems, Invitrogen, Fisher Scientific,
Unity Lab Services and Patheon. For more information, please visit
www.thermofisher.com.
1 The European Economic Area includes the EU:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden
and the following countries: UK, Norway, Iceland, Liechtenstein, Switzerland and Turkey.
Media Contact Information:
Ron O'Brien
Phone: 781-622-1242
E-mail: ron.obrien@thermofisher.com
Investor Contact Information:
Ken Apicerno
Phone: 781-622-1294
E-mail: ken.apicerno@thermofisher.com
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