Predicine Announces Collaboration with Janssen to Develop PredicineCARE™ as a Companion Diagnostic Assay in Localized Bladder Cancer
Collaboration Utilizing PredicineCARE™ Urine cfDNA NGS Assay Marks Progress in Employing Comprehensive Genomic Profiling for Detection of Select Alterations in Localized Bladder Cancer.基于尿液的PredicineCARE™ Urine cfDNA NGS Assay的伴随诊断(CDx) 合作标志着无创伤基因变异检测在局部性膀胱癌临床诊疗中的开创性进展。
HAYWARD, Jan. 8, 2024 /GlOBE NEWSWIRE/ - Predicine, Inc., a leading molecular insights company, today announced a collaboration with Janssen Pharmaceutica NV (Janssen), a Johnson & Johnson company. This collaboration focuses on the development of the PredicineCARE™ urine cell-free DNA (cfDNA) next-generation sequencing (NGS) assay as a companion diagnostic to identify patients who may benefit from targeted therapy.
HAYWARD, Jan. 8, 2024 /Business Wire/ ——行业领先的分子诊断公司 Predicine, Inc. 今天宣布与美国强生公司旗下的杨森制药公司（Janssen Pharmaceutica NV，简称 "杨森"）达成CDx伴随诊断合作，此次合作将围绕PredicineCARE™ Urine cfDNA NGS Assay开展，旨在鉴别具备特定基因变异的那些有可能从靶向治疗中获益的局部性膀胱癌患者。
PredicineCARE™ received Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration on August 23, 2022. PredicineCARE™ is a comprehensive, state-of-the-art NGS assay that interrogates point mutations/indels, fusions, amplifications, and gene deletions in key cancer-associated genes using cfDNA in urine.
PredicineCARE™检测方法已于 2022 年 8 月 23 日获得美国食品药品管理局（FDA）颁发的突破性医疗器械认定 （BDD），可利用尿液中的 cfDNA 检测癌症关键基因的点突变（SNV）、插入和缺失（InDel）、融合（Fusion）、扩增（Amplifications）和基因缺失（Gene deletions）。
Dr. Shidong Jia, Predicine’s Founder, Chairman, and CEO, said in a statement “we are delighted to collaborate with Janssen to develop a cfDNA urine-based assay designed to identify patients with localized bladder cancer who may harbor select alterations and may benefit from targeted therapy.”Predicine创始人、董事长兼首席执行官贾士东博士表示："我们很高兴能与杨森公司合作，开发基于cfDNA尿液的基因检测方法来用于鉴别那些携带特定基因变异、可能从靶向治疗中获益的局部性膀胱癌患者。
About PredicineCARE™ Urine cfDNA Assay
The PredicineCARE™ Urine cfDNA assay is a targeted NGS test that enables detection of genomic alterations, including single nucleotide variants (SNVs), insertions and deletions (Indel), fusions, and copy number variations in urine cfDNA. It is a capture-based assay, which is specifically designed to detect genomic alterations of key cancer relevant genes from urine cfDNA.
关于 PredicineCARE™ urine cfDNA Assay
PredicineCARE™ Urine cfDNA Assay是一款基于二代测序（NGS）技术，分析肿瘤患者尿液样本中游离DNA（cfDNA）的肿瘤体细胞变异检测产品。基于目标区域捕获技术，全面涵盖肿瘤相关基因，检测变异类型包括单核苷酸变异 （SNV）、插入和缺失 （Indel）、融合（Fusion）和拷贝数变异（CNVs）。
Predicine is a leading molecular insights company committed to advancing precision medicine in oncology. Our commitment lies in developing proprietary technologies for cell-free DNA and cell-free RNA liquid biopsy, empowering minimally invasive molecular diagnoses across various stages of disease management, including treatment selection, therapy response assessment, minimal residual disease (MRD) monitoring, and early cancer detection. The Predicine portfolio comprises state-of-the-art blood, urine, and tissue-based Next-Generation Sequencing (NGS) assays designed for harmonized global use in research, clinical investigation, and companion diagnostic (CDx) development. With operational hubs in Silicon Valley, Houston, Chicago, Shanghai, Beijing, and Suzhou, Predicine collaborates with leading biopharma companies, institutions, and governments in personalized healthcare on a global scale. For more information, please visit us on http://www.predicine.com and follow us on LinkedIn or Twitter (X).
Predicine 是一家行业领先的分子诊断公司，致力于推进肿瘤学领域的精准医疗。我们致力于开发独特的cfDNA+cfRNA 联合液体活检技术，涵盖疾病管理的各个阶段（包括分子诊断、治疗选择、治疗反应评估、微小残留病灶（MRD) 监测和早期癌症检测。Predicine 系列产品包括最先进的基于血液、尿液和组织的新一代测序（NGS) 检测方法，用于全球标准一致的临床试验和伴随诊断 (CDx) 开发。在硅谷、休斯顿、芝加哥、上海、北京和苏州设有运营中心。Predicine 与国际顶尖的制药公司、医疗机构和政府合作，在个性化医疗健康领域开展大规模合作。了解更多信息请访问我们的网站 http://www.predicine.com， 访问LinkedIn 或 Twitter (X)。
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