Roche launches comprehensive genomic profiling kit to expand access to personalized cancer research

Roche has announced that it has launched the AVENIO Tumor Tissue CGP Kit. The Kit complements the current CGP portfolio offered by Roche and Foundation Medicine and allows laboratories to expand their oncology research in-house. Ultimately, a future version of the kit may lead to additional resources for clinicians to use in the diagnosis and treatment of cancer.

Cancer is a disease of the genome and treatment no longer depends solely on the tissue of origin. Rather, cancer is a collection of dozens or even hundreds of diseases driven in part by specific genomic characteristics.

“To treat cancer effectively, we must understand what drives it at a molecular level. CGP helps inform decisions about available treatment options, including targeted therapies, immunotherapies, tumor-agnostic treatments and clinical trial participation, based on the unique genomic profile of a patient’s tumor,” said Thomas Schinecker, CEO of Roche Diagnostics. “We are bringing powerful insights from CGP to enable smarter, more efficient research and development. Our new kit provides the information researchers need and will ultimately provide insights physicians can use to develop personalized treatment strategies for individual patients.”

Unlike smaller panels such as hotspot or single gene tests, CGP tests deliver comprehensive information in a single test and can also provide information on complex genomic signatures such as Tumor Mutational Burden (TMB), Microsatellite Instability (MSI) and Loss of Heterozygosity (LOH).

The kit for research use is just the first step in bringing CGP closer to people living with cancer through enabling critical research and clinical trials in laboratories across the world. The kit will launch in regions throughout the world including Europe, North America, Asia and South America. Roche and Foundation Medicine also plan to develop additional solutions for its portfolio.

“The launch of this kit will significantly expand access to genomic profiling globally by providing an in-house solution for those who cannot otherwise access our portfolio of tests through our centralized laboratories,” said Foundation Medicine Chief Executive Officer Brian Alexander. “The launch of the kit strengthens our ability to act as an essential partner to researchers in navigating the complex landscape of cancer care.”

About the AVENIO Tumor Tissue CGP Kit

The AVENIO Tumor Tissue CGP Kit is a Research Use Only next-generation sequencing test that provides an end-to-end workflow from DNA extraction and library preparation to generation of variant results by the FoundationOne Analysis Platform via AVENIO Connect. The Kit uses a gene panel based on the FoundationOne platform that was designed to match the FoundationOne CDx panel content to analyze 324 cancer-related genes across four main classes of genomic alterations and genomic signatures known to cause and drive cancer. These genes provide valuable insights on biomarkers known today and emerging biomarkers of tomorrow.

Each of the kits is configured for running 24 samples, with the entire workflow from DNA isolation to variant results completed in 5 days. The kit runs on Illumina’s NextSeq 500/550 RUO and NextSeq 550 Dx System in research mode. In January 2020, Roche entered into an agreement with Illumina to develop, manufacture and commercialize AVENIO tests for both tissue and blood for use on Illumina’s IVD systems.

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