Latest news with #KathyDavy
Business Wire
14-07-2025
- Business
- Business Wire
Thermo Fisher Scientific Introduces the Oncomine Comprehensive Assay Plus on the Ion Torrent Genexus System to Help Advance the Future of Precision Medicine
CARLSBAD, Calif.--(BUSINESS WIRE)--Today, Thermo Fisher Scientific announced that the Oncomine™ Comprehensive Assay Plus* is now available on the Ion Torrent™ Genexus™ System* helping accelerate precision oncology research. The Oncomine Comprehensive Assay Plus detects a broad range of genomic alterations in 517 genes and will now be able to deliver comprehensive genomic profiling (CGP) results as soon as the next day, enabled by Ion Torrent technology and easy, automated workflows. CGP facilitates the simultaneous analysis of a broad range of biomarkers in one test to maximize insights on the underlying oncogenic drivers in a timely manner. Already available on the Ion GeneStudio™ S5 systems*, the Oncomine Comprehensive Assay Plus detects single-nucleotide variants, insertions and deletions, copy number variations, and fusions. Additionally, the assay detects genomic signatures such as homologous recombination deficiency (HRD), tumor mutational burden (TMB) and microsatellite instability (MSI). With the capabilities of the Genexus System, researchers can now detect a broad range of these important biomarkers, quickly and easily. 'We have been waiting for this complete and rapid CGP solution that includes all the relevant biomarkers including TMB, MSI and HRD,' said Hector M Alcaraz, MS, Founder of Imagene Health, SA de CV, an early access user of the Oncomine Comprehensive Assay Plus on the Genexus System. 'This will make CGP more accessible to our local markets so that we can drive the future of precision medicine forward.' The Genexus System is an automated and integrated NGS platform capable of delivering NGS results as soon as the next day. With end-to-end automation that requires less hands-on time, the Genexus System makes genomic profiling accessible to more researchers with varying levels of experience. Now, with the Oncomine Comprehensive Assay Plus available on the Genexus System, research teams can leverage this end-to-end solution to deliver accurate and robust CGP results as soon as the next day. 'In recent years, new genomic insights have played an essential role in advancing our understanding of human health and driving novel drug development,' said Kathy Davy, president of Clinical Next Generation Sequencing at Thermo Fisher Scientific. 'The addition of the Oncomine Comprehensive Assay Plus on the Genexus System brings the benefits of rapid CGP to more labs, empowering researchers to leverage more comprehensive results at a much faster pace and accelerate what could be life-saving research.' For more information about the Oncomine Comprehensive Assay Plus on the Genexus System and how this is enabling research labs to accelerate oncology research, please visit *For Research Use Only. Not for use in diagnostic procedures. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $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
Business Wire
03-07-2025
- Business
- Business Wire
Thermo Fisher's NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling
CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine™ Dx Express Test on the Ion Torrent™ Genexus™ Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal's ZEGFROVY ® (sunvozertinib) and in tumor profiling. This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to where patients receive care. With the ability to deliver essential genomic insights in as little as 24 hours*, this approval helps advance the accessibility of precision oncology tools and enables more timely decision making. A patient's tumor profile has the potential to guide precision oncology care. However, delays in obtaining results can hinder clinicians' ability to make informed decisions, potentially causing patients to miss out on targeted therapies, which can impact treatment efficacy and patient outcomes. Furthermore, a significant number of patients miss out on targeted therapies due to inefficiencies or lack of access to testing, highlighting the critical role of timely genomic profiling. The Oncomine Dx Express Test was designed to simplify the NGS workflow and connect patients everywhere to precision oncology. Now with the Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer, laboratories across a variety of clinical settings can deliver rapid genomic profiling with exceptional accuracy and ease, helping to ensure patients can benefit from the latest advancements in precision oncology. The Oncomine Dx Express Test is intended for use as a companion diagnostic for ZEGFROVY (sunvozertinib), a targeted therapy from Dizal, to identify patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. In addition, the test has been approved for tumor profiling in solid tumors and detects cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes. Accelerating informed precision oncology care The Genexus Dx Integrated Sequencer automates the NGS workflow — from sample preparation to data analysis and reporting — making the technology accessible to more laboratories, including those that are smaller and without previous NGS expertise. It also enables laboratories to generate timely CDx results as well as tumor profiling reports in as little as 24 hours, helping accelerate insights and access to precision oncology. 'NGS has been instrumental in advancing precision oncology, but these insights often aren't available early enough to inform real-world care,' said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. 'With our rapid NGS solutions, we aim to deliver timely results to clinicians and their patients prior to the initiation of treatment. We've been leading companion diagnostics in collaboration with our pharma partners for a decade, and this approval signifies the next step in our journey bringing rapid, decentralized NGS CDx to drug development. We are proud of our collaboration with Dizal to bring ZEGFROVY to the US market.' Biodesix, one of Thermo Fisher's collaborators in the validation of Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer, will be the first lab to launch testing services. 'The Biodesix team is excited at the prospect of using the newly FDA approved Genexus Dx Integrated Sequencer for clinical testing using the Oncomine Dx Express test and for supporting our biopharma client projects,' said Gary Pestano, Ph.D., chief development officer at Biodesix. "Automation of the systems for nucleic acid purification, library preparation, sequencing and report generation has the potential to significantly improve our NGS laboratory workflows by reducing hands-on time and by delivering rapid turnaround times - from sample receipt to results.' ZEGFROVY (sunvozertinib) CDx approval ZEGFROVY, developed by Dizal, was granted FDA accelerated approval following Breakthrough Therapy designation and Priority Review for the treatment of NSCLC patients with EGFR exon 20 insertion mutations. With the approval of the Oncomine Dx Express Test on the Genexus Dx Integrated Sequencer as a companion diagnostic for this therapy, clinicians can now quickly identify eligible patients – supporting earlier intervention and expanding access to targeted therapy. 'ZEGFROVY is a highly effective and currently the only approved EGFR TKI targeting EGFR exon 20 insertion mutations. The approval of ZEGFROVY will have a significant impact on platinum-pretreated patients with NSCLC harboring EGFR exon 20 insertion mutations, a difficult-to-treat lung cancer subtype,' said Susan Chen, senior vice president, head of clinical operation at Dizal. 'Today's FDA approval of the Oncomine Dx Express Test offers access to ZEGFROVY through decentralized companion diagnostic testing. The ability to match patients to our therapy quickly and accurately, regardless of mutation location, can improve outcomes for this patient population.' To learn more about today's approval, please visit About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $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
Business Wire
28-05-2025
- Business
- Business Wire
Thermo Fisher Scientific Celebrates Precision Oncology Advancement at ASCO 2025
CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, will showcase some of the technologies that have helped power precision oncology at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Through poster presentations, abstracts, and an end-to-end presence across oncology diagnostics, clinical trials, and drug development, Thermo Fisher will demonstrate how its integrated solutions – from biomarker discovery to commercialization – are improving access to targeted cancer therapies. By advancing NGS technologies that prioritize speed, accuracy, and accessibility, the company, through its clinical sequencing business, is helping to ensure that patients in all care settings benefit from the latest innovations. This year marks a significant milestone for Thermo Fisher: a decade of pharma partnership in NGS companion diagnostics development and commercialization, supporting new drug launches globally with decentralized in-country CDx solution. This commitment extends to its clinical research capabilities. Over the past five years, Thermo Fisher has supported more than 750 hematology and oncology clinical trials, involving over 175,000 patients at more than 35,000 sites in over 100 countries. Through its PPD™ clinical research business, the company takes a patient-centered approach to trial design and execution, ensuring that studies are not only scientifically rigorous but also more accessible and inclusive. 'Reflecting on the last decade of partnership with pharmaceutical companies and their therapeutic innovations, we're proud to continue our legacy as a trusted partner and celebrate the impact these collaborations have had on expanding access to precision cancer care,' said Kathy Davy, president of Clinical Next-Generation Sequencing at Thermo Fisher Scientific. 'Behind every test is a patient waiting for answers. That's what drives us – equipping clinicians with fast, reliable insights so they can make confident, timely treatment decisions that change lives.' Davy will deliver opening remarks at the Canadian Evening at ASCO 2025, hosted by Breast Cancer Canada. Held Friday, May 30, at the Marriott Marquis Chicago, this event brings together researchers, clinicians, advocates, and industry leaders to celebrate progress in cancer research. Research and Abstract Highlights at ASCO 2025 At ASCO 2025, researchers from Thermo Fisher and its customers will present new data on precision oncology, including: Assessment of Homologous Recombination Deficiency and BRCA Status (Abstract 3130, Poster presentation) - evaluates a decentralized NGS assay for identifying HRD and BRCA mutations in ovarian cancer. Combined Genomic Profiling of cfDNA and ctDNA – demonstrates how dual analysis of cfDNA and ctcDNA using a prostate cancer-specific panel can provide complementary molecular insights. Association between Targeted Therapy and Survival in Patients with AML (Abstract e23283 in collaboration with EVERSANA) - analyzes real-world data showing improved survival in high-risk MDS patients receiving targeted therapies based on genetic mutations. Attendees can connect with Thermo Fisher experts at booth #12049 to learn more about how the company supports oncology programs from research through commercialization. About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $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
