- Collaboration will start with development of a companion diagnostic for Larotrectinib, the first and only TRK inhibitor approved in the U.S. for patients with TRK fusion cancer across all solid tumors; Larotrectinib is under review in other markets around the world
- Goal is to advance broad patient access to comprehensive genomic testing in line with Bayer’s commitment to precision medicine
Cambridge, Mass, USA / Berlin, May 29, 2019 – Bayer AG and Foundation Medicine, Inc. today announced a global collaboration for the development and commercialization of NGS-based companion diagnostics. This agreement allows for collaboration across multiple oncology drug candidates and approved therapies developed by Bayer and covers Foundation Medicine’s full portfolio of tests, including FoundationOne®CDx. The first project will be to develop a companion diagnostic for Larotrectinib, the first and only TRK inhibitor approved in the U.S. for patients with TRK fusion cancer across all solid tumors.
NGS-based companion diagnostic tests aim to unlock molecular information from each patient’s tumor genome to guide treatment decisions for cancer therapies. FoundationOne®CDx is the first FDA-approved broad companion diagnostic for all solid tumors.
“We are excited to collaborate with Foundation Medicine to develop new companion diagnostics and provide tools to move to a more personalized treatment approach”, said Robert LaCaze, Member of the Executive Committee of Bayer's Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. “The development of a companion diagnostic for Larotrectinib, and our broader collaboration with Foundation Medicine, is an important step forward toward expanding access to testing and identifying the right treatment options for patients with cancer.”
“Foundation Medicine is proud to collaborate with Bayer to develop multiple companion diagnostics including a companion diagnostic for Larotrectinib”, stated Cindy Perettie, Foundation Medicine’s Chief Executive Officer. “It is imperative that patients receive broad comprehensive genomic profiling at initial diagnosis of late stage cancer to determine if they are eligible for these medicines.”
Financial terms of the agreement were not disclosed.
About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing-based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes five marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.
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 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 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: www.FoundationMedicine.com or on Twitter (@FoundationATCG).
Sarah-Christine Wanner, +49 30 468-193178
Anna Koch, phone +49 30 468-15942
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Lee-Ann Murphy, +1 617-245-3077
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