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.
About Business Wire
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
Inversago Pharma Doses First Patient in Phase 2 Trial of INV-202, an Oral, Peripherally-acting CB1 Inverse Agonist, in Patients with Diabetic Kidney Disease29.11.2022 13:00:00 CET | Press release
Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD). The Phase 2 trial of INV-202, a first-in-class, peripherally-acting CB1 inverse agonist, is a multi-centered, randomized, double-blind, placebo-controlled study that will evaluate the albumin to creatinine ratio in up to 240 adult subjects with type 1 and type 2 diabetes and DKD. Participants will receive once-daily oral doses of 10 or 25mg of INV-202 or placebo during the 16-week study. Additional trial information can be found at https://clinicaltrials.gov/ via the identifier NCT05514548. This study builds on positive Phase 1b data that will be presented at a future scientific conference. It is also supported by evidence from pre-clinical data, first presented at the European Renal Association meeting in Ju
BGI Preparing to Launch Improved Non-invasive Colorectal Cancer Screening Test, COLOTECT™ 3.029.11.2022 11:54:00 CET | Press release
COLOTECT™ 3.0 is a non-invasive colorectal cancer screening test developed by BGI, and will be launched in early 2023. BGI plans to release pre-clinical case-control data for COLOTECT™ 3.0 at the 2023 ASCO Gastrointestinal Cancers Symposium. The sensitivity for detecting CRC is 96.08%. The sensitivity for detecting advanced precancerous lesions (APL) is 52.5%, which is better than FIT products. COLOTECT™ 3.0 is a non-invasive colorectal cancer (CRC) self-sampling test that can detect the methylation status of exfoliated cell genes and the Fecal Occult Blood in the stool. It can help screen for colorectal cancer and advanced precancerous lesions (APL) even in the absence of active bleeding lesions. Colorectal cancer is the third most common cancer and the second deadly cancer worldwide. There were more than 1.9 million new cases of colorectal cancer in 2020. Older age, a history of bowel disease, a family history of related diseases, having type 2 diabetes, overweight or obesity, certai
Talkdesk Chosen as Wallbox Contact Center Solution29.11.2022 11:30:00 CET | Press release
Talkdesk®, Inc., a global cloud contact center leader for customer-obsessed companies, has been selected by Wallbox as its contact center solution provider. Wallbox selected the Talkdesk solution as part of a digital transformation for their contact center, improving both agent engagement and customer experience (CX). Wallbox is an EV charging and energy management company dedicated to changing the way the world uses energy. The company, headquartered in Barcelona, develops advanced EV charging systems that allow users to better manage their energy use and storage, redefining reliance on the energy grid. With offices worldwide, customers across 113 countries, and a geographically diverse workforce of over 1,000 people, Wallbox is committed to eliminating the barriers to EV adoption and helping to accelerate a global transition to more sustainable, efficient, and smart mobility. Talkdesk CX Cloud™, an end-to-end customer experience solution, will provide Wallbox with a modernized, cloud
Kaneka to Manufacture and Supply Intermediates for Shionogi COVID-19 Drug29.11.2022 11:26:00 CET | Press release
Kaneka Corporation (Headquarters: Minato-ku, Tokyo; President: Minoru Tanaka) will manufacture and supply intermediates to Shionogi & Co., Ltd. (Headquarters: Chuo-ku, Osaka; Chief Executive Officer: Isao Teshirogi, Ph.D.) for use in Xocova®*1 (Ensitrelvir Fumaric Acid) Tablets 125mg, a drug for the treatment of SARS-Cov-2 infection. On November 22, Shionogi received emergency regulatory approval from the Ministry of Health, Labour and Welfare to manufacture and sell Xocova® tablets for treating SARS-Cov-2 infection. Shionogi recognized Kaneka for its long years of experience in manufacturing raw materials for medicines, and selected Kaneka as its main supplier for the drug's intermediates, which require GMP*2 management. The two companies have worked closely together for clinical development, approval application, and establishment of mass production supply chain. Kaneka will continue to improve its manufacturing systems and provide Shionogi with a stable supply of intermediates, play
Truvant Receives Procter & Gamble External Business Partner Excellence Award29.11.2022 10:00:00 CET | Press release
Packaging services provider Truvant is pleased to announce that it has received the Procter & Gamble External Business Partner Excellence Award in recognition of Truvants performance and long-standing relationship with the consumer goods giant. The External Business Partner Excellence Award was created by P&G to honor the contributions of those suppliers that have "gone above and beyond in delivering value" to the business. Truvant is the largest pure-play packaging services provider in the world, delivering manufacturing, packaging, and display solutions to the world’s leading brands. The company delivers high-quality, flexible, efficient, and sustainable packaging solutions that help brands get their products to the consumer in the most efficient way possible. Truvants solutions are designed to reduce costs, improve speed to market, create agility and manage complexity while reducing the impact on the environment. Procter & Gamble is one of the many long-standing clients that have be
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