CGP test provides comprehensive information in a single test, as well as information on complex genomic signatures such as tumour mutational burden (TMB), microsatellite instability (MSI) and loss of heterozygosity (LOH)
The administration and R&D buildings of Roche Diagnostics, Rotkreuz. (Credit: F. Hoffmann-La Roche Ltd)
Roche has expanded its comprehensive genomic profiling (CGP) portfolio with the introduction of a new AVENIO Tumour Tissue CGP Kit.
The jointly-developed product, which is said to complement the current CGP portfolio provided by Roche and its subsidiary Foundation Medicine, will enable laboratories to expand their in-house oncology research.
The future version of the kit is also expected to result in additional resources for clinicians to use in the diagnosis and treatment of cancer.
Roche Diagnostics CEO Thomas Schinecker said: “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, tumour-agnostic treatments and clinical trial participation, based on the unique genomic profile of a patient’s tumour.”
The research use only next-generation sequencing test is designed to deliver an end-to-end workflow from DNA extraction and library preparation to generation of variant results by the FoundationOne Analysis Platform through AVENIO Connect.
By using a gene panel based on the FoundationOne platform, the kit will help match the FoundationOne CDx panel content to analyse 324 cancer-related genes across four main classes of genomic alterations and genomic signatures known to cause and drive cancer.
Each kit is designed to run 24 samples, and the entire workflow from DNA isolation to variant results will be completed in five days.
In contrast to smaller panels such as hotspot or single-gene tests, the CGP test provides comprehensive information in a single test and information on complex genomic signatures such as tumour mutational burden (TMB), microsatellite instability (MSI) and loss of heterozygosity (LOH).
Foundation Medicine CEO Brian Alexander said: “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 centralised laboratories.”
Illumina’s NextSeq 500/550 RUO and NextSeq 550 Dx System will be used in research mode to run the kit.
In January last year, Roche signed an agreement with Illumina to develop, produce and market AVENIO tests for both tissue and blood for use on Illumina’s IVD systems.
The AVENIO Tumour Tissue CGP Kit will be distributed in regions across the world, including Europe, North America, Asia and South America.
Roche and Foundation Medicine are also planning to expand their portfolio by the development of additional solutions.
Recently, Roche partnered with PathAI to develop artificial intelligence (AI) based digital pathology applications for enhanced patient care.