Roche Canada announces FoundationOne® Liquid CDx now available in Canada

Comprehensive pan-tumour liquid biopsy test analyzes >300 cancer-associated genes and multiple genomic signatures to inform treatment choices

MISSISSAUGA, ON, Sept. 8, 2020 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) today announced that FoundationOne® Liquid CDx, Foundation Medicine's comprehensive pan-tumour liquid biopsy test for patients with solid tumours, is now available in Canada.

FoundationOne Liquid CDx is a comprehensive genomic profiling (CGP) test that analyzes >300 cancer-associated genes and multiple genomic signatures to inform the use of targeted oncology therapies, including immunotherapies. Using a simple blood draw, the test allows more patients with advanced cancer to benefit from the insights of comprehensive genomic profiling, when a tissue biopsy is not possible, recommended or can be safely replaced.

In 2020, 225,800 Canadians are expected to be diagnosed with cancer¹ — a disease of the genome, driven by genetic mutations within a tumour's DNA.² Comprehensive Genomic Profiling (CGP) can be used to identify these unique mutations to understand how a tumour behaves and grows, and these insights can help physicians to determine a personalized treatment plan for each individual patient based on the specific mutations identified.^3,4,5,6,7

"This test brings us closer to a precision approach to cancer therapy for all of our patients," said Dr. Natasha Leighl, Professor of Medicine at the University of Toronto and Medical Oncology Lung Site Lead at Princess Margaret Cancer Centre. "Liquid biopsies have transformed our ability to diagnose and create optimal treatment plans for our patients through a blood test in place of an invasive tumour biopsy."

Using a blood sample, FoundationOne Liquid CDx analyzes over 300 cancer-related genes for alterations. FoundationOne Liquid CDx results are delivered in an integrated report that identifies alterations matched to US FDA-approved therapies and, within its professional services section, delivers information about the genomic signatures microsatellite instability and blood tumor mutational burden, as well as single gene alterations, including all NTRK fusions, to help inform the use of other therapies including immunotherapies. The report also provides relevant clinical trial information and includes interpretive content developed in accordance with professional guidelines in oncology for patients with any solid tumor.

"In this era of precision medicine, the molecular profile of a patient's individual tumour can help them and their medical team make important treatment decisions," said Shem Singh, Executive Director Lung Cancer Canada. "Blood based testing solutions such as FoundationOne Liquid CDx are non-surgical methods that can provide patients with this information, helping us move towards truly personalized medicine."

FoundationOne Liquid CDx is the latest addition to Foundation Medicine's portfolio of high-quality CGP tests. Together, the high-quality FoundationOne Liquid CDx and FoundationOne CDx genomic profiling tests have the potential to help improve patient outcomes by assisting oncologists to optimize and personalize treatment approaches for their patients with advanced cancer, during all lines of therapy.

For more information about FoundationOne Liquid CDx, please visit:
https://www.foundationmedicine.ca/FoundationOneLiquidCDx.aspx

About FoundationOne® Liquid CDx
FoundationOne Liquid CDx is a next-generation sequencing service that analyzes 324 genes. Substitutions and insertion and deletion alterations (indels) are reported in 311 genes; copy number alterations and gene rearrangements are reported in select genes. FoundationOne Liquid CDx utilizes circulating cell-free DNA isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients. FoundationOne Liquid CDx is intended to provide tumour mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with malignant neoplasms. FoundationOne Liquid CDx is a single-site assay performed at Foundation Medicine Inc. laboratories located in Cambridge Massachusetts, USA. Hoffmann-La Roche Limited markets these services in Canada under an exclusive license.

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
under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

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.

Founded in 1931, Roche Canada is committed to searching for better ways to prevent, diagnose and treat diseases while making a sustainable contribution to society. The company employs more than 1,200 people across the country through its Pharmaceuticals division in Mississauga, Ontario and Diagnostics, as well as Diabetes Care divisions in Laval, Quebec.

Roche aims to improve patient access to medical innovations by working with all relevant stakeholders. Roche Canada is actively involved in local communities through its charitable giving and partnerships with organizations and healthcare institutions that work together to improve the quality of life of Canadians. For more information, please visit www.RocheCanada.com.

All trade-marks mentioned are the property of their respective owners.

© Copyright 2020; Hoffmann-La Roche Limited

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¹ Canadian Cancer Society. 6 statistics that reveal the impact of cancer in Canada for 2020. Available at: https://www.cancer.ca/en/about-us/our-stories/6-statistics-about-cancer-in-canada-for-2020/?region=nu [Accessed June 2020].

² Canadian Cancer Society. Genes and cancer. https://www.cancer.ca/en/cancer-information/cancer-101/what-is-cancer/genes-and-cancer/?region=nu [Accessed June 2020].

³ Brenner DR et al. Projected estimates of cancer in Canada in 2020. CMAJ 2020 March 2;192:E199-205. doi: 10.1503/cmaj.191292

⁴ Hirshfield KM, Tolkunov D, Zhong H, et al. Clinical Actionability of Comprehensive Genomic Profiling for Management of Rare or Refractory Cancers. Oncologist. 2016;21(11):1315-1325. doi:10.1634/theoncologist.2016-0049

⁵ Rankin A, Klempner SJ, Erlich R, et al. Broad Detection of Alterations Predicted to Confer Lack of Benefit From EGFR Antibodies or Sensitivity to Targeted Therapy in Advanced Colorectal Cancer. Oncologist. 2016;21(11):1306-1314. doi:10.1634/theoncologist.2016-0148

⁶ Batlevi, C, Moskowitz, C. H, Zelenetz, A. D, et al. Identification of Actionable Genomic Alterations Across Different Lymphoma Histologies Using a Comprehensive Next Generation Genomic Sequencing Clinical Assay. Blood, 124(21), 3000-3000. doi:10.1182/blood.v124.21.3000.3000

⁷ Suh JH, Johnson A, Albacker L, et al. Comprehensive Genomic Profiling Facilitates Implementation of the National Comprehensive Cancer Network Guidelines for Lung Cancer Biomarker Testing and Identifies Patients Who May Benefit From Enrollment in Mechanism-Driven Clinical Trials. Oncologist. 2016;21(6):684-691. doi:10.1634/theoncologist.2016-0030

SOURCE Hoffmann-La Roche Limited (Roche Canada)

Bridget Wells, Roche Canada, T: 905-542-5072; Sydney Dubin, Proof Strategies, T: 416-969-2816