Two Contract Research Organizations (CROs) with leading expertise in molecular testing have decided to utilize the new Oncomine Cancer Research panel, which runs on Life Technologies Ion Torrent sequencing instruments, for clinical trial analyses and design.
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 Brian Druker, M.D., Ph.D. (lead clinical investigator for Gleevec, 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.
Selah Genomics is a clinical diagnostics specialist supporting early stage drug development, clinical trials and regulatory processes in the pharmaceutical industry and helping clinicians and healthcare providers to treat and monitor patients.
“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 and 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.”
“Limited amounts of biopsy tissue is a key challenge in oncology – especially for lung cancer patients,” said Michael Bolick, chief executive officer of Selah Genomics, Inc . “Concurrent analysis of DNA and RNA will reduce the need for repeat biopsy and expand the availability of archived specimens needed for biomarker discovery. We are particularly keen to leverage this technology in development of a universal companion diagnostic for our pharma partners. ”
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.”