Roche Singapore launches FoundationOne CDx, an extensively validated comprehensive genomic profiling assay, to help guide personalised treatment decisions

Roche Media Release

• FoundationOne CDx analyses the tumour genome to identify clinically relevant genomic alterations in a broad range of cancers and provides insights which can help support treatment decisions
• FoundationOne CDx assesses over 300 of the most commonly mutated genes known to drive the growth of cancer and reports tumour mutational burden and microsatellite instability
• FoundationOne CDx is based on an analytically and clinically validated, US Food and Drug Administration-approved comprehensive platform

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that FoundationOne®CDx, Foundation Medicine’s comprehensive companion diagnostic test for personalised cancer care, has launched in Singapore. FoundationOne CDx supports clinicians in their decision-making by providing a clear, in-depth report that describes the unique genomic profile of a patient’s tumour as well as associated, approved therapies and relevant clinical trials.^1,2 FoundationOne CDx is the next evolution of FoundationOne®, Foundation Medicine’s original laboratory-developed genomic profiling test. In the United States, the FoundationOne CDx platform has been reviewed and approved by the US Food and Drug Administration, including analytical and clinical validation, and bioinformatics^.1,2

“The biggest advantage of next generation sequencing is that it can capture all the essential cancer biomarkers to help clinicians select the right therapy for patients in a single testing attempt, particularly when tumour samples are limited,” said Dr Tay Miah Hiang, Senior Consultant Medical Oncologist at OncoCare Cancer Centre. In addition, with the increasing use of immunotherapy, foundation medicine is able to provide information about Programmed death-ligand 1 (PD-L1), tumour mutational burden (TMB) and microsatellite instability (MSI) statuses that allow clinicians to identify patients who may benefit from the cancer immunotherapy.”

FoundationOne CDx includes an updated gene list, comprising all main classes of genomic alterations in 324 of the most commonly mutated genes known to drive the growth of cancer. The test also reports tumour mutational burden (TMB) and microsatellite instability, genomic signatures which can help inform cancer immunotherapy-based treatment decisions.^1,3-4

“Upfront testing of TMB and additional biomarkers are beneficial to physicians, as they would have more information to guide their treatment selection and the patient would have access to more treatment options,” said Dr Ravindran Kanesvaran, Consultant in the Division of Medical Oncology at the National Cancer Centre Singapore and Chair of the International Society of Geriatric Oncology task force for kidney cancer in the elderly.

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.5 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 Inc. Media release [Internet: accessed September 2018]. Available from: http://investors.foundationmedicine.com/news-releases/news-release-details/fda-approves-foundation-medicinesfoundationone-cdxtm-first-and

[2] Foundation Medicine Inc. FoundationOne CDx Technical Information. [Internet: accessed September 2018]. Available from: https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170019C.pdf

[3] Hellman MD, et al. Nivolumab plus Ipilimumab in Lung Cancer with a High Tumor Mutational Burden. N Engl J Med. 2018; 378:2093-2104.

[4] Dudley JC, et al. Microsatellite Instability as a Biomarker for PD-1 Blockade. Clin Cancer Res. 2016; 22:813-20

[5] Foundation Medicine website: FoundationOne CDx – “Go Beyond FoundationOne®”. [Internet: accessed September 2018]. Available from: https://www.foundationmedicine.com/genomic-testing/foundation-one-cdx

Media contact

Payal Sadhwani on behalf of Roche Singapore

WE Communications

psadhwani@we-worldwide.com

+65 9654 6453