WALTHAM, Mass., May 12, 2020 /PRNewswire/ -- Thermo Fisher
Scientific Inc. (NYSE: TMO), the world leader in serving science,
today announced that the U.S. Food and Drug Administration (FDA)
has further expanded emergency use authorization (EUA) for its
multiplex real-time PCR test intended for the qualitative detection
of nucleic acid from SARS‑CoV‑2, the virus that causes
COVID-19.
"Increasing COVID-19 testing is a top priority in re-opening
global economies," said Marc N.
Casper, chairman, president and chief executive officer of
Thermo Fisher Scientific. "With this expanded authorization,
additional instrumentation can be brought on line in labs around
the world and the number of tests they can run will increase, which
will help to support the need for more testing as people start
returning to work."
Thermo Fisher's Applied
Biosystems TaqPath COVID-19 Combo Kit, initially granted EUA on
March 13 and subsequently expanded on
April 20, is designed to deliver test
results within four hours of a sample being received and processed
by a CLIA high-complexity laboratory. This third expansion further
increases the number of high-throughput PCR instruments that labs
can use to run tests and also provides new options for reagents and
consumables used in sample preparation and extraction to provide
greater flexibility in testing workflows.
In addition to the previously approved Applied Biosystems 7500
Real-time PCR series and a version of the Applied Biosystems
QuantStudio 5, labs can now run tests on specific configurations of
QuantStudio 7 Flex and QuantStudio 5 Real‑time PCR instruments,
contributing significantly to the number of instruments available
for testing.
This expanded EUA also increases the availability of RNA
extraction reagents by adding the company's MagMAX viral/pathogen
II nucleic isolation kit as an alternative. Additionally, the
sample purification step has been updated to allow a variety of
microplate options.
For details regarding the specific additions to the EUA,
including simplified workflows and updated COVID-19 Interpretive
Software, visit www.thermofisher.com/covid19eua.
TaqPath COVID-19 Combo Kit has not been FDA cleared or
approved and is only authorized for the duration of the EUA granted
under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
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.
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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SOURCE Thermo Fisher Scientific