Roche announces global availability of blood-based genomic profiling test, FoundationOne Liquid

• Liquid biopsy test can identify 70 of the most commonly mutated genes in solid tumours, as well as microsatellite instability
• Many cancer patients have insufficient or inadequate tissue for genomic testing and so may benefit from FoundationOne Liquid
• FoundationOne Liquid joins FoundationOne CDx to deliver a complementary portfolio which provides insights to personalise a patient's treatment plan

             
Basel, 24 September 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the global availability of FoundationOne^®Liquid, a liquid biopsy test. FoundationOne Liquid can identify circulating tumour DNA in the blood of people living with cancer and can identify 70 of the most commonly mutated genes in solid tumours, including microsatellite instability, a genomic signature which may help inform cancer immunotherapy based treatment decisions. ^[1,2] From a single blood sample, the liquid biopsy offers a quick and convenient option for some patients with solid tumours. ^[3]

FoundationOne Liquid meets a compelling need for comprehensive genomic profiling for people who have insufficient or inadequate tissue, including those with advanced non-small cell lung cancer, where an estimated 15% of patients are not eligible for tissue biopsy and approximately 10% have a biopsy size that is insufficient to evaluate. ^[4-6] FoundationOne Liquid complements FoundationOne CDx, a tissue-based genomic profiling test launched in the US earlier this year, to deliver a portfolio of comprehensive genomic profiling services for healthcare professionals.

"Cancer is a disease of the genome and genomic profiling of every patient's tumour at the start of their treatment journey will provide transformative outcomes for patients," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "At Roche, we believe the use of innovative profiling technologies like FoundationOne Liquid and FoundationOne CDx will improve access to targeted cancer treatments for patients and enrich the future development of targeted medicines."

About FoundationOne Liquid
FoundationOne Liquid is a liquid biopsy circulating tumour DNA (ctDNA) test that complements FoundationOne CDx, a tissue-based test. The blood sample is sent to a Foundation Medicine lab where the test is performed using next generation sequencing to analyse the four main classes of genomic alterations as well as microsatellite instability, an indicator that may help inform immunotherapy treatment decisions using ctDNA isolated from plasma derived from peripheral whole blood.

About FoundationOne CDx
FoundationOne CDx is based on the first US Food and Drug Administration-approved broad companion diagnostic assay to assess the four main classes of genomic alterations and identify patients with advanced cancer who are likely to respond to targeted therapies based on their individual genomic profile. The tissue sample is sent to a Foundation Medicine lab where the test is performed using next generation sequencing to analyse the four main classes of genomic alterations, as well as microsatellite instability and tumour mutational burden, using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumour tissue specimens. The test has been validated with 2,100 clinical samples and 4,200 analytical samples. ^[7] FoundationOne CDx is intended to be used by clinicians as decision-making support in consideration of a patient's genomic profile for therapy selection and patient management according to professional guidelines in oncology for cancer patients.

About Foundation Medicine
Foundation Medicine 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. The company, a member of the Roche Group, offers a full suite of comprehensive genomic profiling tests to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer.

For more information, please visit http://www.foundationmedicine.com or follow Foundation Medicine on Twitter (@FoundationMedicineATCG).

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 personalised 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 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. 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 tenth consecutive year, Roche has been recognised as the most sustainable company 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 2017 employed about 94,000 people worldwide. In 2017, Roche invested CHF 10.4 billion in R&D and posted sales of CHF 53.3 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.

All trademarks used or mentioned in this release are protected by law.
References
[1] Foundation Medicine. FoundationOne Liquid Technical Specifications [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-liquid.
[2] Dudley JC, et al. Microsatellite Instability as a Biomarker for PD-1 Blockade. Clin Cancer Res. 2016; 22:813-20.
[3] Clark TA, et al. Analytical Validation of a Hybrid Capture-Based Next-Generation Sequencing Clinical Assay for Genomic Profiling of Cell-Free Circulating Tumor DNA. J Mol Diagn. 2018; S1525-1578(17)30527-5 [Epub ahead of print].
[4] Rafael OC, et al. Molecular Testing in Lung Cancer: Fine-Needle Aspiration Specimen Adequacy and Test Prioritization Prior to the CAP=IASLC=AMP Molecular Testing Guideline Publication. Cancer Cytopathology. 2014; 122(6):454-458.
[5] Douillard JY, et al. Gefitinib Treatment in EGFR Mutated Caucasian NSCLC. J Thorac Oncol. 2014; 9:1345-1353.
[6] Kim ES, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008; 372:1809-18.
[7] Foundation Medicine website: FoundationOne CDx - "Go Beyond FoundationOne®" [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

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