Thermo Fisher Scientific, a Waltham, Mass.-based healthcare equipment company, has inked 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.
Companion diagnostics refers to tests that help identify those patients who are most suitable for treatment with targeted therapies. For many cancer types, patient tumor samples are tested to ascertain the presence or absence of actionable genetic markers, information that can help physicians choose a course of action best suited for each patient. Since cancer is known to be complex and highly heterogeneous, up to hundreds of genetic markers must be interrogated to fully understand the genetic profile of an individual tumor. Current genomic analysis technologies, however, interrogate only one or a few genetic markers at a time, requiring large amounts of sample input and taking weeks to deliver all of the relevant information for therapy selection.
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. Furthermore, due to AmpliSeq technology’s uniquely 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.
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 next-generation sequencing for therapy selection and clinical trial matching in the future.
“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,” said Dan Rhodes, head of oncology for life science solutions at Thermo Fisher Scientific. “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.”
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 of these are targeted by oncology drugs currently on the market and an additional 44 are used in determining eligibility for current clinical trials. This panel capitalizes on the investments made by Thermo Fisher Scientific over the last two years.
“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.”