Thermo Fisher Scientific Partners with Pfizer, GSK for Companion Diagnostics

Thermo Fisher Scientific and pharmaceutical companies GlaxoSmithKline and Pfizer have entered into an agreement 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 US Food and Drug Administration (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.

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. Developed using the industry's most robust oncology database containing more than one billion data points of curated oncology data, this panel capitalizes on the investments made by Thermo Fisher Scientific over the last two years.

Source: Thermo Fisher

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