WALTHAM, Mass., Nov. 29, 2021 /PRNewswire/ -- Thermo Fisher
Scientific Inc. (NYSE:TMO), the world leader in serving science,
today confirmed that its polymerase chain reaction (PCR) TaqPath
COVID-19 Combo Kit*, and TaqPath COVID-19 CE-IVD RT-PCR Kit*, which
test for the presence of SARS-CoV-2, are not impacted by the
emerging B.1.1.529, or Omicron variant, enabling accurate test
results.
The Omicron variant, which was designated a "variant of concern"
by the World Health Organization (WHO), has more than 30 mutations
in the spike protein alone. The WHO has reported that preliminary
evidence suggests an increased risk of transmission compared to
other variants of concern. This designation and information are
leading to renewed travel restrictions and research to examine the
variant's impact on efficacy of existing vaccines and tests. The
WHO and European Centers for Disease Control have both reported
that using S-gene target failure (SGTF) of the PCR assays as a
proxy for the variant helped to identify Omicron. Cases of the
variant were first identified in South
Africa and have now been reported in at least a dozen
countries around the world.
The TaqPath COVID-19 assays detect SARS-CoV-2 infections by
identifying the presence of three gene targets from the orf1a/b, S,
and N regions of the virus. By surveying across multiple genes, the
test can report accurate results even in the case where one of the
targets is impacted by a mutation. While the S gene target in the
test is impacted in the presence of Omicron variant mutations, the
orf1a/b and N gene targets in the TaqPath COVID-19 tests have been
determined to not be impacted by any of the mutations in the
Omicron variant, based on assessment of sequences in the GISAID
public database. As a result, the overall accuracy of the TaqPath
COVID-19 assays is not impacted.
The Omicron variant has been found to include the 69-70del
mutation of the S gene, first identified as a mutation in the Alpha
variant. This mutation causes a dropout of the S-gene target in
results from the TaqPath test, which could indicate to clinicians
and researchers a possible Omicron variant infection. Confirmation
must then be performed by sequencing the sample.
"The Thermo Fisher test allowed us to detect cases that may
contain the new variant by identifying samples exhibiting S-gene
dropout," said Tulio de Oliveira,
director of the Centre for Epidemic Response and Innovation (CERI),
Stellenbosch University and UKZN, South
Africa. "This early identification is very important in
helping us track and understand the spread of the B.1.1.529 variant
to South Africa and the
world."
In addition to the original TaqPath COVID-19 tests, Thermo Fisher has developed the TaqPath COVID-19
2.0 tests with an advanced assay design to compensate for emerging
mutations. The TaqPath COVID-19 2.0 assays detect the presence of
SARS-CoV-2 by utilizing eight gene targets across the orf1a/b and N
regions of the virus. These assays were also assessed against
sequences in the GISAID public database and confirmed in silico to
detect all B.1.1.529 mutations with no loss in sensitivity.
"Like all viruses, we have always known that SARS-CoV-2 would
continue to mutate, and that effective testing strategies are a key
to curbing the pandemic," said Mark
Stevenson, executive vice president and chief operating
officer, Thermo Fisher Scientific. "That is why we developed assays
with additional built-in checks and balances, to ensure that
clinicians, researchers and public health officials would have
effective tools to accurately test for COVID-19 even as the genetic
makeup of the virus evolved."
Specific genotyping assays to detect the Omicron variant are
being developed for Thermo Fisher's
TaqMan Mutation Panel. The panel, which is currently used for
research purposes, already has a menu of over 50 assays to assess
confirmed COVID-19 cases for the presence of known variants and
mutations.
Thermo Fisher is committed to
supporting the world's pandemic response by monitoring new
SARS-CoV-2 variants and developing innovative, adaptive and
resilient testing solutions. This work helps track and subsequently
limit the spread of COVID-19, helping communities stay healthy.
The original TaqPath kit received emergency use authorization
from the United States Food and Drug Administration (FDA) in
March 2020, and the 2.0 version of
the kit received EUA in August 2021.
The TaqPath COVID-19 CE-IVD RT PCR Kit launched in March 2020 and the 2.0 version launched in June
2021. For more information, please visit:
https://www.thermofisher.com/covid19
*In the EU, the TaqPath products are For In Vitro Diagnostic
Use; in the U.S., the TaqPath products are for In Vitro Diagnostic
Use, For Emergency Use Only, By prescription only.
About Thermo Fisher Scientific
Thermo Fisher
Scientific Inc. is the world leader in serving science, with annual
revenue of approximately $35 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 90,000 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
Sheela Pawar
Phone: +41 (79) 8615867
E-mail: sheela.pawar@thermofisher.com
Investor Contact Information:
Rafael Tejada
Phone: 781-622-1356
E-mail: rafael.tejada@thermofisher.commailto:
View original
content:https://www.prnewswire.com/news-releases/thermo-fisher-scientific-confirms-detection-of-sars-cov-2-in-samples-containing-the-omicron-variant-with-its-taqpath-covid-19-tests-301432661.html
SOURCE Thermo Fisher Scientific