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Thermo Fisher Scientific to Develop NGS-based Oncology Companion Dx with Pfizer, GSK

NEW YORK (GenomeWeb) – Thermo Fisher Scientific, GlaxoSmithKline, and Pfizer are collaborating to develop a universal next-generation sequencing-based oncology test for solid tumors that will serve as a companion diagnostic for several drug programs, Thermo said today.

Following development and validation, Thermo Fisher plans to submit the test to the US Food and Drug Administration for premarket approval, as well as to other regulatory agencies.

The test will be developed on the Ion PGM Dx platform, which the company recently listed as a class II medical device with the FDA, and will use the Ion AmpliSeq amplification technology.

The test will include markers from Thermo Fisher's Oncomine Cancer Research panel, which analyzes single nucleotide variants, copy number variants, gene fusions, and insertions and deletions across 143 cancer genes. Of those genes, 26 are targeted by oncology drugs already on the market and 44 are used to help determine enrollment of cancer patients in clinical trials.

According to the company, the PGM platform and AmpliSeq technology enable the analysis of hundreds of genes from tumor samples and are compatible with low amounts of genetic material from samples such as small biopsies or fine needle aspirates.

"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," Dan Rhodes, head of oncology for life science solutions at Thermo Fisher, said in a statement.

"Looking forward, we see many great benefits that will come from changing the paradigm within clinical oncology from one test for one drug to one test for many targeted therapies to provide benefit for our clinical customers and most importantly, cancer patients," said Mark Stevenson, president of life sciences solutions at Thermo Fisher, in a statement.

The announcement comes a month after Illumina said it is developing a universal next-generation sequencing-based oncology test for use as a companion diagnostic with AstraZeneca, Janssen Biotech, and Sanofi using its MiSeqDx sequencing platform.