Thermo Fisher Scientific and pharmaceutical companies GlaxoSmithKline and Pfizer have entered into an agreement to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs. Thermo Fisher intends to submit this test for premarket approval to the Food and Drug Administration (FDA) and other global regulatory authorities following successful development and validation of the test. The test will be developed using Thermo Fisher Scientific’s Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel.
Using the Ion PGM Sequencing Platform combined with Ion AmpliSeq technology, hundreds of genes can be simultaneously analyzed from tumor samples via next-generation sequencing, with high reproducibility and rapid turnaround time. Due to AmpliSeq technology’s low DNA and RNA sample input requirements from FFPE tissue (10ng extracted nucleic acid per reaction), the Ion PGM-based sequencing platform can enable comprehensive sequence analysis of a larger range of tumor samples, including small biopsies and fine needle aspirates, in conjunction with other required pathology tests.
The development of this new universal companion diagnostic test will include markers from the Oncomine Cancer Research panel, which enables simultaneous testing of single nucleotide variants (SNVs), copy number variants (CNVs), gene fusions, and indels across 143 unique cancer genes. Among the genes within the new panel, 26 are targeted by oncology drugs currently on the market and an additional 44 are used in determining eligibility for current clinical trials. The panel was developed using an oncology database containing more than one billion data points of curated oncology data. Learn more about the Oncomine Cancer Research Panel and workflow.
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