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Thermo Fisher Scientific has signed an agreement with GlaxoSmithKline (GSK) and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumours, which will be used as a companion diagnostic for multiple drug programmes.

The test is being developed using Thermo Fisher’s Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel.

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.”

“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.”

Thermo Fisher plans to apply for premarket approval to the US Food and Drug Administration (FDA) and other global regulatory authorities, after the development and validation of the test.

More number of genes can be simultaneously analysed from tumour samples through next-generation sequencing using the Ion PGM Sequencing Platform combined with Ion AmpliSeq technology.

AmpliSeq technology will reduce DNA and RNA sample input requirements from FFPE tissue, while Ion PGM Sequencing Platform allows in sequence analysis of a wide range of tumour samples, including small biopsies and fine needle aspirates, in conjunction with other required pathology.

The markers from the Oncomine Cancer Research panel will help in simultaneous testing of single nucleotide variants (SNVs), copy number variants (CNVs), gene fusions, and indels across 143 unique cancer genes.


Image: GlaxoSmithKline headquarters in Brentford, London, England. Photo: courtesy of Maxwell Hamilton.