June 2, 2014
MolecularMD to Adopt Oncomine Cancer Research Panel with Ion Torrent Next-Generation Sequencing Platform
CARLSBAD, Calif. – June 2, 2014– MolecularMD will be validating the Oncomine Cancer Research Panel in their CLIA and FDA 21 CFR part 820 compliant diagnostic testing facility to provide comprehensive genomic tumor profiling to support early and late stage clinical development of molecularly targeted cancer therapies.
This comprehensive multi-biomarker assay allows concurrent analyses of DNA and RNA in one workflow, allowing researchers to simultaneously detect all four classes of tumor-driving alterations: single nucleotide variants, copy number variants, tumor suppressors and gene fusions. As CROs and their pharma partners validate their use of this new tool, the potential exists for patients to be more effectively enrolled into clinical trials and study designs made easier.
Founded in 2005 by Dr. Brian Druker (lead clinical investigator of imatinib, the first molecularly-targeted anticancer agent) and Sheridan G. Snyder (entrepreneur, founder of Genzyme and Upstate Biotechnology), MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications across the entire oncology pharmaceutical development life cycle.
“We see the Oncomine Cancer Research Panel as a valuable tool in advancing MolecularMD’s comprehensive companion diagnostics program, and personalized medicine in general,” stated Glenn Miller, Executive Vice President and CTO of MolecularMD. “The Ion PGM platform, combined with this new panel, meets many of our needs to support drug – diagnostic regulatory submissions with specific actionable genetic markers, while generating a breadth of additional data from variants that can be used in identifying novel drug sensitivities in the future. The Oncomine Cancer Research Panel makes an excellent addition to the broad menu of services we offer to the global biopharmaceutical community.”
The Oncomine Cancer Research panel enables simultaneous testing of 160 known cancer genes. The panel employs Life Technologies Ion AmpliSeq chemistry, which requires a very small amount of starting material — as little as 10 nanograms of DNA or RNA from formalin-fixed paraffin-embedded tissue — which is often extremely limited in tumor specimens.
“Content for the Oncomine Cancer Research Panel was selected by leveraging the expertly curated data in the Oncomine Knowledgebase, a long-trusted source of oncology data for pharmaceutical companies, the translational research community, and CROs,” said Dan Rhodes, Ph.D., head of oncology strategy, life sciences solutions, for Thermo Fisher. “The combination of one of the world’s largest collection of oncology data with the rapid, simple-to-use Ion sequencing technology positions Thermo Fisher Scientific as a game-changing company in the oncology clinical research space.”
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. 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 and increase laboratory productivity. Through our four premier brands – Thermo Scientific, Life Technologies, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
MolecularMD Corporation develops and commercializes specialty molecular diagnostics for oncology applications across the entire oncology pharmaceutical development life cycle. Its tests are designed to assist pharmaceutical companies with selection, monitoring and management of patients treated with molecularly-targeted cancer therapies. MolecularMD integrates gold-standard and innovative platform technologies with custom clinical assay design and validation to accelerate all phases of clinical development, including FDA approval and commercialization of in vitro companion diagnostic tests for novel anticancer agents.