Thermo Fisher Scientific has entered into partnership with GlaxoSmithKline (GSK) and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumours, which can be used as a companion diagnostic for multiple drug programmes.
The new test will be developed using the company’s Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel.
After successful development and validation of the test, the company plans to submit this test for premarket approval to the US Food and Drug Administration (FDA) and other global regulatory authorities.
Thermo Fisher Scientific Oncology for Life Science Solutions head Dan Rhodes said: "To realise the promise of personalised 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.
"This approach will help ensure that cancer patients have an opportunity to potentially benefit from a targeted therapy associated with their tumour’s genetic profile."
Various genes can be simultaneously analysed from tumour samples through next generation sequencing using the Ion PGM Sequencing Platform combined with Ion AmpliSeq technology.
Thermo Fisher Scientific Life Sciences Solutions president Mark Stevenson said: "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 tumour samples each month using Ion Torrent technology."
The markers from the Oncomine Cancer Research panel will allow in simultaneous testing of single nucleotide variants (SNVs), copy number variants (CNVs), gene fusions, and indels across 143 unique cancer genes.
The company said that 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.