WALTHAM, Mass., May 13, 2020 /PRNewswire/ -- Thermo Fisher
Scientific Inc. (NYSE: TMO), the world leader in serving science,
announced it will expand its response to the COVID-19 pandemic by
developing a total antibodies test in collaboration with WuXi
Diagnostics and Mayo Clinic. The new test is the result of ongoing
collaboration between all three organizations, including clinical
evaluation and support from Mayo Clinic. Thermo Fisher will seek U.S. FDA Emergency Use
Authorization (EUA) and international regulatory authorizations for
the test over the next few weeks.
Once approved for use, the Thermo Scientific OmniPath COVID-19
Total Antibody ELISA test will detect Immunoglobulin M (IgM) and
Immunoglobulin G (IgG) to help clinicians determine if a patient
has been exposed to SARS-CoV-2. The test is designed to run on an
open instrument platform, and the determination of antibody status
will aid in the diagnosis of the disease during the acute and
recovery stages of infection.
"Since the outbreak was first detected, we have mobilized our
scientific, regulatory and commercial teams to support virus
analysis, identification, deployment of personal protective
equipment as well as development of therapies and vaccines,"
said Marc N. Casper, chairman, president and chief executive
officer of Thermo Fisher Scientific. "Stopping the spread of
COVID-19 requires comprehensive testing solutions, and we are very
pleased to join forces with WuXi Diagnostics and Mayo Clinic to
respond to the widespread need for antibody-based tests. Working
together, we will now be able to provide governments, healthcare
systems and communities with yet another important tool to aid in
the fight against the pandemic."
The global call to ramp up testing requires a combination of
both PCR-based molecular tests and serological tests. Molecular
tests, such as Thermo Fisher's
Applied Biosystems TaqPath Combo Kit, are considered the gold
standard for determining if a patient has an active infection.
Serological tests determine if a patient has antibodies to
SARS-CoV-2 that indicate whether they have had – or still have –
the virus and have built up an immune response. When used in
combination, these tests provide greater clinical efficacy, support
contact tracing and enhance epidemiological efforts to stop the
spread of the virus.
Thermo Fisher will begin
manufacturing the Thermo Scientific OmniPath COVID-19 Total
Antibody ELISA test at its sites in the U.S. and Europe in the next few weeks as it prepares to
submit for EUA.
Jason
Liu, Ph.D., chief executive officer of WuXi
Diagnostics, said, "We are pleased to join forces with
Thermo Fisher and Mayo Clinic in the
battle against the pandemic. This global collaboration of R&D,
clinical expertise, manufacturing
and commercialization capability will significantly
advance serological testing for COVID-19. WuXi Diagnostics
offers an open-access platform for innovative diagnostic
solutions. By collaborating with our
partners, we're dedicated to
supporting healthcare professionals and their patients around the
world."
Gianrico Farrugia, M.D., chief
executive officer and president of Mayo Clinic, said, "Rapidly expanding access to high-quality
testing requires bold collaborations across the laboratory
industry. This marks a significant milestone in our national
testing response to COVID-19 and was made possible by bringing
together the commercialization capabilities of Thermo Fisher
Scientific, testing development abilities of WuXi Diagnostics, and
clinical and laboratory expertise of Mayo Clinic physicians and
scientists."
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