Thermo Fisher Scientific Launches CE-IVD (IVDD) Next-Generation Sequencing Test and Analysis Software to Expand Access to Precision Oncology Biomarker Testing
Next-generation sequencing (NGS) is quickly becoming the platform of choice for tumor molecular profiling due to its ability to simultaneously report on multiple biomarkers. However, lengthy turnaround times can limit the clinical utility of these results. To meet the need for rapid genomic insights, Thermo Fisher Scientific today launched the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx for use in clinical labs.
Using targeted NGS technology, the Oncomine Dx Express Test delivers clinically relevant tumor mutation profiling in as little as 24 hours to aid healthcare professionals, in accordance with professional guidelines, in therapy management of cancer patients. The qualitative in vitro diagnostic (IVD) test detects deletions, insertions, substitutions and copy number gain present in 42 genes and fusions or splicing variants in 18 genes from DNA and RNA in FFPE tumor tissue samples of solid malignant neoplasms. This assay also detects deletions, insertions, substitutions in 42 genes and fusions or splicing variants in seven genes from cfTNA extracted from plasma samples of non-small cell lung cancer (NSCLC). The assay requires minimal sample input, maximizing sample success rates.
The Oncomine Reporter Dx software ensures healthcare providers can quickly assess the genomic test results. The software matches the variant data to relevant evidence including approved therapies, guidelines, clinical trials and peer reviewed literature in a user-friendly and customizable report.
“Genomic profiling in precision oncology is transforming cancer care, but true clinical utility hinges on timely, actionable results,” said Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “By delivering an IVD NGS solution that provides rapid results with minimal training and hands-on time, we’re working to make these insights available in any lab or hospital to help connect patients to precision oncology treatments.”
The new NGS assay and genomic reporting software, along with the recently launched Ion Torrent Genexus Dx Integrated Sequencer, offer an automated end-to-end CE-IVD workflow. Operated from a single software interface, the overall process includes less than 20 minutes of hands-on time, delivering results with unprecedented rapid turnaround time. The workflow enables any lab to bring the power of genomic testing in-house, improves access to patients and advances precision oncology for those who stand to benefit most.
For more information on the Oncomine Dx Express Test and the Oncomine Reporter Dx, please visit oncomine.com/express-test.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD. For more information, please visit www.thermofisher.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220829005097/en/
Contact information
Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com
Jessika Parry
Phone: 419-266-4016
Email: jparry@greenough.biz
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
AI’s Water Demand to Surge Nearly 130% by 2050 – New Research Shows How to Build a Water-Secure AI Economy14.1.2026 17:00:00 EET | Press release
The rapid global expansion of artificial intelligence is set to drive a 129% increase in water demand across the AI value chain by 2050, according to new research by Xylem (NYSE: XYL) and Global Water Intelligence (GWI). Watering the New Economy: Managing the Impacts of the AI Revolution provides the most comprehensive assessment to date of how AI is reshaping global water use. It also highlights practical ways to meet that demand while strengthening water security for communities. Spending on AI is forecast to approach $2 trillion in 2026,1 accelerating infrastructure build-out worldwide. By the middle of the century, this expansion is projected to add 30 trillion liters of water demand, annually, fueled by a surge in power generation (~54% of the increase), semiconductor fabrication (~42%), and data center expansion (~4%). Crucially, the report finds that this additional demand does not have to result in competition between industry and communities. Today, global water systems proces
Primient to Acquire Full Ownership of Primient Covation, LLC14.1.2026 17:00:00 EET | Press release
Primient, a global leader in biomanufacturing, announced today it has agreed to purchase the remaining ownership interest in Primient Covation, LLC (“Primient Covation”), establishing Primient as the sole owner of the company and marking an exciting new chapter in Primient’s growth in the bioeconomy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114344080/en/ This acquisition is the next step of Primient’s strategy to strengthen Primient’s leadership position in biomanufacturing and builds upon recent announcements, including Primient’s partnership with Sustainea and the creation of the iPROOF venture. Primient Covation stands as a leading force in the U.S. biomanufacturing sector, distinguished by its broad range of biomanufacturing and fermentation expertise. The company was founded in 2000 to supply a variety of end markets, including cosmetics and personal care, textiles, fashion, coatings, functional fluids, and oth
ACCELQ Crowned Leader and Customer Favorite in The Forrester Wave™ for Autonomous Testing Platforms14.1.2026 17:00:00 EET | Press release
Forrester has named ACCELQ a Leader in The Forrester Wave™: Autonomous Testing Platforms, Q4 2025. This marks the third consecutive Wave in which ACCELQ has been recognized as a Leader. Notably, this evaluation placed strong emphasis on generative AI innovation and real-world customer adoption. ACCELQ received the highest scores for both capabilities and vision and was the only platform to be recognized as a Customer Favorite, earning a "double halo" for exceptional customer endorsement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260113112861/en/ ACCELQ recognized as a Leader and Customer Favorite in The Forrester Wave™️: Autonomous Testing Platforms, Q4 2025, validating its agentic, GenAI-embedded testing vision. According to the Forrester report, ACCELQ received the highest score among all evaluated vendors in the Current Offering category. Analysts praised the platform’s "impressive vision and innovation," specificall
Paysafe Research: First-Time and Casual Betting to Surge for 2026 World Cup14.1.2026 16:10:00 EET | Press release
19% of global consumers with an interest in following this summer’s 2026 World Cup plan to place their first ever online bet during the soccer tournament, according to research issued today by leading payments platform Paysafe (NYSE: PSFE). The company’s All the Ways Players Pay: World Cup 2026 report also indicates that brand reputation and offering flexible, reliable payments will be crucial for online sportsbooks when converting and retaining new and experienced bettors alike. With the World Cup returning to North America for the first time since 1994, there is strong appetite for online wagering in the host countries of the U.S., Mexico, and Canada as well as in Europe and Latin America, with 60% of global fans planning to bet. Across U.S. states where sports betting is legal, 62% intend to wager, with 29% placing their first ever bet. The surge is expected to be even stronger in Mexico, with 68% planning to wager, including 26% for the first time. And even in Canada, 46% of Ontari
Joint Cross-industry Statement: Cement Industry Co-Processing Should Be More Widely Adopted for Global Sustainable Waste Management14.1.2026 16:00:00 EET | Press release
Leading industry organisations today issued a joint statement highlighting the substantial and positive contribution the cement industry can make to addressing the urgent global challenge of non-recyclable and non-reusable waste. The Global Cement and Concrete Association – GCCA; European Composites Industry Association (EuCIA); International Solid Waste Association – Africa; Mission Possible Partnership; and The Global Waste-to-Energy Research and Technology Council – WtERT® are calling for stronger policy support to unlock the full potential of cement industry co-processing as a safe, effective and sustainable global waste management solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260114232332/en/ Co-processing enables both energy recovery and material recycling. It uses waste to replace fossil fuels in heating cement kilns, while any remaining ashes are simultaneously recycled into the building material compound
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom