AMSTERDAM, MADRID, CARLSBAD, Calif. – (August 31, 2017) – Thermo Fisher Scientific has formed the Immuno-Oncology Consortium to drive adoption of highly sensitive, next-generation sequencing (NGS) clinical research panels designed to help identify predictive and prognostic biomarkers associated with cancer immunotherapy. Recognizing this shift toward a multi-targeted approach to detect a broad set of gene variants with a single panel, the company has also launched the Ion AmpliSeq Immune Repertoire Assay Plus, TCR beta and expanded its portfolio of liquid biopsy assays for analysis of cell-free nucleic acid (cfNA) in lung and breast cancer.
Led in collaboration with Dr. Sabine Merkelbach-Bruse from the Institute of Pathology of the University of Cologne, the Immuno-Oncology Consortium brings together a prestigious group of clinical researchers from renowned institutions in Europe. The consortium will initially spearhead efforts to validate Thermo Fisher’s previously launched Oncomine Immune Response Research Assay with the expectation to extend studies with the new immune repertoire assay and an application to interrogate tumor mutational burden currently under development by Thermo Fisher.
“Next-generation sequencing holds great promise in developing new biomarkers for immuno-oncology research,” said Dr. Merkelbach-Bruse. “As our lab has extensive expertise in working in multi-center studies, we believe that the consortia model is the best approach to perform analytical validation of new assays, and to explore how these assays may assist in the future to help with patient stratification for immuno-therapies.”
Professor Jose Carlos Machado, group coordinator for the Institute of Molecular Pathology and Immunology of the University of Porto (IPATIMUP) in Porto, Portugal, and an Immuno-Oncology Consortium member said: “T-cell receptor diversity holds great promise as a universal cancer immunotherapy biomarker. Our preliminary results using the new Ion AmpliSeq Immune Repertoire Assay Plus, TCR beta in a colon cancer clinical research study demonstrated that the assay offers a complete and efficient workflow for better characterization of the entire V(D)J region of TCR beta and enables the characterization of tumor-infiltrating T-cells.”
Scientists believe that harnessing the power of T-cell receptor diversity may help identify predictive and prognostic biomarkers associated with cancer immunotherapy, monitor treatment resistance, and optimize the manufacture and function of therapeutic T-cells. Similarly, studies to advance the utility of liquid biopsy applications in cancer remain of significant interest. Its ability to provide a non-invasive method to detect tumor cells or circulating cell-free nucleic acids in blood enables tumor heterogeneity and recurrence research today with potential for therapeutic response monitoring in the future. To meet this demand, Thermo Fisher has added two new panels to its portfolio of cell-free DNA research assays.
The Ion Torrent Oncomine Lung Cell-Free Total Nucleic Acid (cfTNA) Research Assay has been designed to include fusion markers associated with lung cancer, including ALK, RET and ROS1, in addition to DNA, RNA hotspots, copy number variants (CNVs) and MET exon 14 skipping. The Ion Torrent Oncomine Breast cfDNA Research Assay has also been updated. Version 2 now includes new CNVs, more complete coverage of key tumor suppressor gene TP53 and additional SNVs and indels. From a single tube of blood, researchers can use the assays to detect primary tumor drivers and mutations known to cause therapeutic resistance down to 0.1 percent limit of detection.
“Insights to tumor heterogeneity is extremely important in oncology studies,” says Dr. Bea Bellosillo, head of section from the Pathology Department at Hospital del Mar, and a member of the Immuno-Oncology Consortium who will present results of a liquid biopsy clinical study at European Society of Medical Oncology congress. “In our research, the Oncomine Colon cfDNA Assay and the Ion S5 System together presented a next-generation sequencing, multi-biomarker approach that successfully detected genomic heterogeneity in 94 percent of the research metastatic colorectal cancer samples after anti-EGFR therapy. With this level of performance, we are very excited about the new liquid biopsy assays that offer new gene coverage for CNVs and fusions, and have already begun our evaluation.”
“Thermo Fisher’s growing portfolio of targeted NGS assays designed to simultaneously interrogate many informative biomarkers empower researchers with a robust and multi-disciplinary approach to drive discoveries across many cancer types,” said Andy Felton, PhD, vice president of product management, clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “Our strategic collaborations across the globe help accelerate development of these technologies, so we are looking forward to kicking-off our Immuno-Oncology Consortium at the European Congress of Pathology meeting.”
Thermo Fisher will feature its new NGS assays for immuno-oncology and liquid biopsy research at the European Congress of Pathology (ECP), booth #20, and at the European Society of Medical Oncology (ESMO) Congress, booth #15. Additional information on featured talks and presentations for each meeting can be found here.
Ion AmpliSeq Immune Repertoire Assay Plus, TCR beta, Oncomine Lung cfTNA Research Assay and Oncomine Breast cfDNA Research Assay are for research use only; not for use in diagnostic procedures.
About the Immuno-Oncology Consortia
The Immuno-Oncology Consortia members include these researchers with plans to expand to additional institutions across Europe:
- Sabine Merkelbach-Bruse, Institute of Pathology, University Hospital Cologne
- Albrecht Stenzinger, Institute of Pathology, University Hospital Heidelberg
- Michael Hummel, Institute of Pathology, Charite - University Medicine Berlin
- Wilko Weichert and Nicole Pfarr, Institute of Pathology, Technical University Munich
- Bea Bellosillo, Servei de Patologia, Hospital del Mar, Barcelona
- Nicola Normanno, Istituto Nazionale Tumori “Fondazione G. Pascale” - IRCCS, Napoli, Italy
- Jose Carlos Machado, i3S and IPATIMUP, Porto, Portugal
- Maurice Jansen and Winand Dinjens, Erasmus MC Cancer Institute, Rotterdam
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market, and increase laboratory productivity. Through our premier brands—Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, and Unity Lab Services—we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.