Thermo Fisher Scientific Confirms Detection of SARS-CoV-2 in Samples Containing the Omicron Variant with its TaqPath COVID-19 Tests

- 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.com   mailto:

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

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Orchestra BioMed Reports Full Year 2023 Financial Results and Provides Fourth Quarter Business Update

  • Initiated enrollment of the BACKBEAT global pivotal study evaluating AVIM therapy (also known as BackBeat Cardiac Neuromodulation Therapy) in hypertensive pacemaker patients in collaboration with Medtronic, plc (NYSE: MDT) in December 2023
  • Orchestra BioMed and Terumo remain actively engaged to update operational plans and financial arrangements for Virtue ® Sirolimus AngioInfusion TM Balloon ("SAB") development and commercialization for treatment of coronary and peripheral artery disease
  • Expected runway of cash and cash equivalents and marketable securities, including certain potential future proceeds sufficient into 2H 2026, beyond anticipated BACKBEAT top-line results readout

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today reported its full year 2023 financial results and provided a fourth quarter business update.

"2023 was a year of strong momentum for Orchestra BioMed as we made significant progress on our cardiovascular pipeline with the achievement of key regulatory milestones and completion of our successful Nasdaq listing," commented David Hochman, chairman, chief executive officer and founder of Orchestra BioMed. "In December, we initiated the BACKBEAT global pivotal study evaluating our lead program, AVIM therapy, in hypertensive pacemaker patients working alongside our strategic partner Medtronic, the global market leader in cardiac pacing therapies. We see a substantial market opportunity for AVIM therapy in this patient population, as well as in other high-risk hypertension populations."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis

The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe aortic stenosis. The latest Evolut FX+ TAVR system maintains the valve performance benefits of the legacy Evolut TAVR platform and is designed to facilitate coronary access.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

U.S. Patent Office rejects Axonics' latest challenge to Medtronic patents

Medtronic moves for patent infringement litigation to resume

Medtronic (NYSE:MDT), the global leader in healthcare technology, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has affirmed the validity of claims in two of its patents in an ongoing patent infringement lawsuit filed by Medtronic against Axonics over sacral neuromodulation (SNM) technologies. Cumulatively, the PTAB has now upheld the validity of five of the Medtronic patents at issue in this lawsuit.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Knight Therapeutics Reports Fourth Quarter and Year-End 2023 Results

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its fourth quarter and year ended December 31, 2023. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2023 Highlights

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Glen Eagle Resources Inc.

(TheNewswire)

Glen Eagle Resources Inc.

Glen Eagle Resources Inc. ( TSX VENTURE: GER) ("Glen Eagle" or the "Company")  announces that the court has homologated the judgement, ordering the Company to pay Gem Yield Bahamas Limited a compensation of $1,875,895 dollars including interest and $90,000 in penalty

News Provided by TheNewsWire via QuoteMedia

Keep reading...Show less

Notice of Knight Therapeutics' Fourth Quarter and Year End 2023 Results Conference Call

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its fourth quarter and year end 2023 financial results on Thursday, March 21, 2024 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

Date : Thursday, March 21, 2024

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×