Foundation Medicine and Sequanta Technologies Forge Comprehensive Partnership to Advance Precision Oncology in China

October 24, 2023,Foundation Medicine, Inc. Announces Partnership with Shanghai Sequanta Biotechnology Co., Ltd. (“Sequanta”) to Expand Collaborative Scope and Jointly Provide Genomic Analysis Services in China to Support Clinical Research on Novel Oncology Drugs and the Development of Innovative TherapiesFoundation Medicine has maintained a long-term partnership with the SEQUANTA team since 2014. In 2015 and 2018, the two parties completed FoundationOne in phases under a collaborative laboratory model.^®and FoundationOne^®CDx Two Product Services' Localization and Implementation in China. It is reported that, following the establishment of this comprehensive partnership,Foundation Medicine will partner with SEQUANTA to complete FoundationOne in November 2023^®Localization of Liquid CDx Technology, with the New Version of FoundationOne Expected to Be Completed in March 2024^®CDx Localization Technology Upgrade.

FoundationOne^®Liquid CDx and FoundationOne^®CDx can analyze more than 300 cancer-related gene mutations.Identifying mutations in patients’ cancer genomes can help researchers streamline clinical trial enrollment and provide prognostic information to support further scientific research. Comprehensive genomic profiling has transformed the traditional “one-size-fits-all” approach to cancer treatment, offering substantial clinical diagnostic and therapeutic value for identifying rare and hard-to-detect mutations.

Pursuant to the agreement executed by both parties,SEQUANTA as the FoundationAs an official partner laboratory of Medicine, it provides testing services to users in China using the same instruments and equipment, standardized laboratory procedures, and quality control parameters as Foundation Medicine’s global laboratories.FFoundation Medicine will ensure that SEQUANTA’s laboratory, alongside its global network of laboratories, delivers reliable test results through its globally standardized technical training requirements, quality control systems, validation studies, and ongoing consistency analysis. These measures guarantee the consistency and accuracy of biomarker data in global multicenter clinical trials, enabling clients to use the relevant experimental data to support regulatory submissions and companion diagnostic kit marketing applications in overseas regions, including the United States, Japan, and the European Union.

Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine“the introduction of FoundationOne Liquid CDx and FoundationOne CDx technologies in China represents a significant step forward in our efforts to provide globally consistent testing methodologies to support biopharmaceutical companies conducting global multi-center clinical trials in China. This collaboration underscores Foundation Medicine’s commitment to advancing precision medicine worldwide and reflects our pursuit of new collaborations and partnerships with our biopharmaceutical partners.”

Dr. Lele Sun, Founder and CEO of SEQUANTAstated, “We are delighted to partner with Foundation Medicine to enter a new phase by offering the fully automated FoundationOne CDx and FoundationOne Liquid CDx assays in the Chinese market. This represents a new milestone achieved by our collaborative teams over the past decade, reflecting the significant efforts invested by both sides.” “Foundation Medicine’s comprehensive genomic profiling technology will strongly support biopharmaceutical companies in global multicenter clinical trials and overseas drug registration processes, providing a one-stop solution. SEQUANTA is committed to introducing top-tier technologies to the Chinese market through high-quality data and an excellent operational management system, which constitutes our differentiated competitive advantage distinguishing us from other providers in the market.”

FoundationOne^®Liquid CDx is an in vitro diagnostic kit based on NGS sequencing technology, used for qualitative analysis of patients with advanced solid tumors.This product analyzes 324 genes for circulating cell-free DNA (cfDNA), with short variant detection for 311 of these genes having received FDA approval. As an approved companion diagnostic test, this product can be used to identify patients who may benefit from specific therapies (see Table 1 in “Intended Use”). Other genomic findings may be reported, but they are not prescriptive or conclusive for the labeled use of any specific therapeutic product. Use of this test does not guarantee that a patient will be matched to a treatment regimen. A negative result does not rule out the possibility of mutations. When considering FoundationOne Liquid CDx as a companion diagnostic for certain therapies, plasma testing is only applicable when tumor tissue is unavailable. If feasible, patients who test negative for mutations via other companion diagnostics should undergo tumor tissue testing, using FDA-approved tumor tissue tests to confirm mutation status. For the complete labeling, including companion diagnostic indications and full risk information, please visitwww.F1LCDxLabel.com。

FoundationOne^®CDx is an in vitro diagnostic kit based on next-generation sequencing (NGS) technology that detects substitutions, insertions and deletions (indels), copy number alterations (CNAs), and selected gene rearrangements across 324 genes, as well as genomic features including microsatellite instability (MSI) and tumor mutational burden (TMB), using formalin-fixed paraffin-embedded (FFPE) tumor tissue samples.FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from certain targeted therapies, in accordance with the approved therapeutic product labels.Furthermore, in accordance with oncology professional guidelines, qualified healthcare professionals use FoundationOne CDx to provide tumor mutation analysis for patients with solid malignant neoplasms. Use of this test product does not guarantee that patients will receive matched therapy. A negative result does not rule out the possibility of mutations. Some patients may require a biopsy. For the complete list of targeted therapies for which FoundationOne CDx is designated as a companion diagnostic, please visitwww.F1CDxLabel.com。

Foundation Medicine is a pioneer in the field of cancer molecular analysis, dedicated to shaping the future of clinical care and research. The company collaborates extensively with partners in the cancer research community, striving to set standards for quality, scientific excellence, and regulatory leadership. Foundation Medicine’s deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and accelerates the development of new drugs by researchers. Every day, the company is committed to helping its partners find answers and take action, enabling more people around the world to benefit from precision cancer treatments. For more information, please visit:www.FoundationMedicine.com。

Sequanta Technologies Co., Ltd. is a service-oriented platform enterprise specializing in sequencing technology services and multi-omics research solutions. Headquartered within the Waigaoqiao Bonded Core Functional Area of the Shanghai Pilot Free Trade Zone, its central laboratory spans over 3,000 square meters and features a large-scale high-throughput sequencing platform, offering more than 300 specialized testing services aligned with omics disciplines. Sequanta is one of the few domestic providers of sequencing and omics technical services to simultaneously hold internationally recognized accreditations, including CLIA, CAP, ISO 15189, and ISO 27001. As a platform dedicated to delivering high-quality biotechnology research services, Sequanta supports flexibly customized development, validation, and testing analysis, providing robust technical support to researchers in the biomedical and pharmaceutical fields.

SEQUANTA is driven by innovation and technology, bringing together a highly professional and experienced R&D team dedicated to delivering high-quality, competitive services. We aim to make sequencing technology accessible to all and empower new drug development with innovative multi-omics technologies!