Thermo Fisher Scientific entered into an agreement with GlaxoSmithKline and Pfizer 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 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 NGS, with high reproducibility and rapid turnaround time, according to a Thermo Fisher official. Furthermore, due to AmpliSeq technology’s low DNA and RNA sample input requirements from FFPE tissue (10 ng 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, said Dan Rhodes, head of oncology for life science solutions at Thermo Fisher Scientific.
Ultimately enabling standardization while working within the current pathology workflow, this technology also has the potential to provide more cancer patients the benefit of actionable information afforded through NGS for therapy selection and clinical trial matching in the future, he added.
“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,” explained Rhodes. “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.”
Last month, Illumina formed collaborative partnerships with AstraZeneca, Janssen Biotech, and Sanofi to develop a universal NGS-based oncology test system. It will be used for clinical trials of targeted cancer therapies with a goal of developing and commercializing a multi-gene panel for therapeutic selection.