CAMBRIDGE, Mass. & SHANGHAI--(BUSINESS WIRE)--Foundation Medicine, Inc., today announced that it has expanded its partnership with Sequanta Technologies Co., Ltd. (“Sequanta”) to provide genomic profiling services to support clinical research and the development of oncology therapies in China. Foundation Medicine has a long-standing partnership with Sequanta as its in-house laboratory in China since 2014 with FoundationOne® and FoundationOne®CDx launches in 2015 and 2018, respectively. With this expanded partnership, Foundation Medicine will conduct a tech transfer of its genomic profiling tests technologies for research and investigational uses starting with FoundationOne®Liquid CDx, a blood-based comprehensive genomic profiling test in November 2023, and a transfer of FoundationOne CDx, a tissue-based comprehensive genomic profiling test, in March 2024.
FoundationOne Liquid CDx and FoundationOne CDx analyze more than 300 cancer-related genes for genomic alterations. Identifying alterations in the cancer genome of a patient can help researchers streamline clinical trial enrollment and provide prognostic predictive insights that inform research. Comprehensive genomic profiling has transformed the traditional ‘one-size fits-all’ approach to cancer and is an important tool for identifying rare and hard to find mutations.
As part of this partnership, Sequanta serves as a partner laboratory to Foundation Medicine and is responsible for performing these tests in China using the same parameters run across Foundation Medicine laboratories, including verification studies and subsequent concordance analysis to demonstrate the comparable performance across sites. This ensures that all data supporting a global clinical trial is of the same quality and accuracy to detect study-specific biomarkers across global sites and that the data can be used to support global regulatory submissions and companion diagnostic submissions in the Unites States, Japan and the EU.
“The tech transfer of FoundationOne Liquid CDx and FoundationOne CDx technologies to Sequanta represents a major step forward in helping provide a unified global registration approach to biopharmaceutical companies to support their global trials in China,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “This partnership demonstrates Foundation Medicine’s commitment to advancing precision medicine around the world and ways to seek new collaborations and partnerships with our biopharmaceutical partners.”
“We are so glad to move into a new stage in partnership with Foundation Medicine to offer fully automated FoundationOne CDx and FoundationOne Liquid CDx assays in China market. This is a new milestone achieved by the two teams who have devoted so many efforts in collaboration over the past decade,” said Lele Sun, PhD, Founder and CEO at Sequanta. "These genomic profiling technologies support biopharmaceutical companies who are seeking unified solutions across the world in clinical trials and drug registration. Sequanta is determined to continuously deliver the top technologies into China with high quality data and excellent operational management system, which differentiates us from other providers in the market.”
About FoundationOne®Liquid CDx
FoundationOne Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyses 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labelling. Additional genomic findings may be reported and are not prescriptive or conclusive for labelled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible. For the complete label, including companion diagnostic indications and complete risk information, please visit www.F1LCDxLabel.com.
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 for prescription use only and 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. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit www.F1CDxLabel.com.
About Foundation Medicine: Your Essential Partner in Cancer Care
Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.
About Sequanta
Sequanta Technologies is a leading multi-omics research and clinical service provider in China, focusing on genomics, proteomics and related services to support pharmaceutical clients in biomarker discovery and clinical trials. Sequanta provides diversified genomics and proteomics assays validated by research standard and CAP standard, which include NGS cancer panels, WGS/WES/RNA-seq, single cell solutions, Olink Target and Explore assays, etc. Customized panels are also available based on specific project needs. Welcome to visit us on www.sequanta.com.
Source: Foundation Medicine
