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Industry trio joins forces for NGS-based cancer diagnostics
CARLSBAD, Calif.—Thermo Fisher Scientific has launched an agreement with GlaxoSmithKline and Pfizer for the development of a universal next-generation sequencing (NGS) test for solid tumors that will serve as a companion diagnostic for a number of drug programs. The test will be developed utilizing Thermo Fisher Scientific’s Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology and content from the Oncomine Cancer Research Panel.
“This collaboration with Pfizer and GSK enables us to build upon our market-leading position in NGS oncology, with hundreds of customers around the world sequencing tens of thousands of tumor samples each month using Ion Torrent technology,” Mark Stevenson, president of Life Sciences Solutions at Thermo Fisher Scientific, noted in a statement. “Looking forward, we see many great benefits that will come from changing the paradigm within clinical oncology from one test for one drug to one test for many targeted therapies to provide benefit for our clinical customers and most importantly, cancer patients.”
The test’s development will include markers from the Oncomine Cancer Research panel, which allows for simultaneous testing of single nucleotide variants, copy number variants, gene fusions and indels across 143 unique cancer genes. Included in the genes on the new panel are 26 genes targeted by cancer drugs currently on the market and 44 genes being used to determine eligibility for existing clinical trials. Thermo Fisher Scientific plans to submit the new test to the U.S. Food and Drug Administration and other global regulatory authorities for pre-market approval once it’s been developed and validated.
“To realize the promise of personalized medicine in oncology, cancer patients increasingly require multiple, complex genetic tests. Together with Pfizer, GSK, and potentially other pharmaceutical companies, we seek to change the paradigm and develop a single next-generation sequencing test that can provide a comprehensive analysis of multiple, relevant genetic markers,” Dan Rhodes, head of Oncology for Life Science Solutions at Thermo Fisher Scientific, commented in a press release. “This approach will help ensure that cancer patients have an opportunity to potentially benefit from a targeted therapy associated with their tumor’s genetic profile.”
While existing genomic analysis technologies only interrogate up to a few genetic markers at once, by combining the Ion PGM Sequencing Platform with Ion AmpliSeq technology, hundreds of genes can be analyzed from tumor samples at once via NGS. The AmpliSeq technology has low DNA and RNA sample input requirements, which allows the Ion PGM-based sequencing platform to perform comprehensive sequence analysis of a larger range of tumor samples.
“An increasing number of new cancer therapies target specific genetic mutations, which sometimes occur in small subsets of patients,” said Rhodes. “The NGS-based approach will help accelerate the development of these promising new therapies and will ultimately help physicians identify clinical trials that help provide their patients with the best possibility of a successful outcome. An important additional benefit of using a multi-marker approach that interrogates many genetic markers simultaneously is that it can also help eliminate the need to develop a unique companion diagnostic test for each new therapy.”
SOURCE: Thermo Fisher Scientific press release