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Predicine Announces Collaboration with Janssen to Develop PredicineCARE™ as a Companion Diagnostic for Localized Bladder Cancer

Jan 09, 2024 09:29 CST Updated 09:29
Predicine

Biopharmaceutical Solutions Provider

Janssen Pharmaceuticals

Pharmaceutical R&D Developer

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.
The companion diagnostic (CDx) collaboration for the urine-based PredicineCARE™ Urine cfDNA NGS Assay marks a groundbreaking advancement in non-invasive genomic variant detection for the clinical diagnosis and treatment of localized bladder cancer.
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/ — Predicine, Inc., a leading molecular diagnostics company, today announced a CDx companion diagnostic collaboration with Janssen Pharmaceutica NV ("Janssen"), a subsidiary of Johnson & Johnson. This collaboration will focus on the PredicineCARE™ Urine cfDNA NGS Assay, aiming to identify patients with localized bladder cancer harboring specific genetic alterations who may benefit from targeted therapy.
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™ Detection Method Receives Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA) on August 23, 2022, for Detecting Point Mutations (SNVs), Insertions and Deletions (InDels), Fusions, Amplifications, and Gene Deletions in Critical Cancer Genes Using cfDNA from Urine.
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.” 
Dr. Shidong Jia, Founder, Chairman and CEO of Predicine, stated: "We are very pleased to collaborate with Janssen to develop a cfDNA urine-based genetic testing method for identifying patients with localized bladder cancer who carry specific genetic mutations and may benefit from targeted therapy."
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.
About PredicineCARE™ Urine cfDNA Assay
PredicineCARE™ Urine cfDNA Assay is a tumor somatic mutation detection product based on next-generation sequencing (NGS) technology, analyzing cell-free DNA (cfDNA) in urine samples of cancer patients. Utilizing targeted region capture technology, it comprehensively covers cancer-related genes, detecting mutation types including single nucleotide variants (SNVs), insertions and deletions (Indels), fusions (Fusion), and copy number variations (CNVs).
About Predicine 
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).
Introduction to Predicine
Predicine is an industry-leading molecular diagnostics company dedicated to advancing precision medicine in the field of oncology. We are committed to developing unique cfDNA+cfRNA combined liquid biopsy technologies, covering all stages of disease management (including molecular diagnostics, treatment selection, treatment response assessment, minimal residual disease (MRD) monitoring, and early cancer detection). The Predicine product portfolio includes state-of-the-art next-generation sequencing (NGS) assays based on blood, urine, and tissue for globally standardized clinical trials and companion diagnostic (CDx) development. With operational centers in Silicon Valley, Houston, Chicago, Shanghai, Beijing, and Suzhou, Predicine collaborates with top international pharmaceutical companies, medical institutions, and governments on large-scale initiatives in personalized healthcare. For more information, please visit our website at http://www.predicine.com, LinkedIn, or Twitter (X).
Contact Information: 
Predicine, Inc. 
media@predicine.com
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PredicineIs a high-tech group company focused on precision medicine. Adhering to the professional standard of "the starting point is the industry's pinnacle," it creates premium products in the liquid biopsy industry.
Starting from European and American pharmaceutical companies, Predicine has uniquely developed a combined liquid biopsy technology of ctRNA + ctDNA in the industry, offering a global solution for precise clinical trials and operating a CAP and CLIA laboratory network in both China and the US. Through an integrated one-stop biomarker platform system based on blood, urine, and tissue, Predicine deeply collaborates with top 10 European and American pharmaceutical companies as well as top experts and medical institutions in and outside of China to support global new drug clinical trials, companion diagnostic development, and early cancer screening.