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

• The AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit is the first jointly-developed product that brings together the expertise and reach of Roche with Foundation Medicine’s pioneering leadership in genomic science.
• This is the first time that research scientists can conduct oncology research with Foundation Medicine’s comprehensive genomic profiling in their own laboratories to gain meaningful genomic insights and deepen their understanding of cancer biology.
• This kit is an important step forward in Roche and Foundation Medicine's vision of enabling personalised healthcare for more patients living with cancer by broadening access to CGP and making it essential in clinical decision making in the future.

Basel, 25 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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, tumour-agnostic treatments and clinical trial participation, based on the unique genomic profile of a patient’s tumour,” 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 personalised 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 Tumour 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 centralised 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 analyse 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 commercialise AVENIO tests for both tissue and blood for use on Illumina’s IVD systems.

About Roche and Foundation Medicine
Foundation Medicine, a wholly owned subsidiary of Roche, is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. Foundation Medicine offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine`s CGP portfolio is available in more than 100 countries worldwide.

About Roche
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the area of data-driven medical insights help Roche deliver truly personalised healthcare. Roche is working with partners across the healthcare sector to provide the best care for each person.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, Roche has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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