WALTHAM, Mass., March 16, 2020 /PRNewswire/ -- Thermo Fisher
Scientific Inc. (NYSE: TMO), the world leader in serving science,
announced that on March 13, 2020, the
U.S. Food and Drug Administration (FDA) issued an emergency use
authorization (EUA) for its diagnostic test that can be used
immediately by CLIA high-complexity laboratories in the U.S. to
detect nucleic acid from SARS-CoV-2, the virus that causes
COVID-19, and not for any other viruses or pathogens.
The authorized test uses Applied Biosystems TaqPath Assay
technology and 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.
On March 13, Marc N. Casper, chairman, president and chief
executive officer of Thermo Fisher Scientific, said, "The
authorization of our diagnostic test for COVID-19 will help to
protect patients and enable medical staff to respond swiftly to
treat those who are ill and prevent the spread of infection. At
Thermo Fisher, our Mission is to enable our customers to make the
world healthier, cleaner and safer. In partnership with the FDA and
regulatory authorities around the world, we are committed to
expanding the availability of diagnostic testing to prevent the
spread of this disease."
Today Thermo Fisher also provided an update on its anticipated
production rate. The company currently has 1.5 million tests
available to ship under the EUA label and expects to quickly ramp
up to reach 2 million tests per week. Based on availability of
raw materials and an installed instrument base, the company expects
to scale production up to 5 million tests per week during the month
of April. The available tests will initially be distributed to
approximately 200 labs in the U.S. and Thermo Fisher will continue
to work in partnership with government agencies and private
partners to expand access.
The EUA test is optimized for use on the company's Applied
Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered
under the EUA and already used in clinical laboratories
worldwide.
This test has not been FDA cleared or approved, however, the FDA
can issue an EUA to permit use of certain medical products that may
be effective in diagnosing, treating or preventing a disease or
condition, as in the case of the novel coronavirus when the
secretary of the U.S. Department of Health and Human Services (HHS)
declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on
January 31. The test is only
authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro
diagnostic tests for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless
the authorization is terminated or revoked sooner.
For more information about the test, visit
www.thermofisher.com/COVID19EUA
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