Time:May 09-10, 2019
Country&Region: China Mainland
Venue:Shanghai
Organizer:BMAP
As NMPA successively approved the registration of NGS panel products for tumor diagnosis, more and more cutting edge genetic detection technologies, such as Next-generation sequencing, are moving from laboratory to clinic, from service to product. However, the LDT mode approach to IVD registration also brings new challenges:
In the face of the competing and fragmented landscape of the molecular diagnostic industry and practice challenges, MDx2019(5th Novel Molecular Diagnostics Summit China) will discuss molecular diagnostic product registration and technical standards,breakthrough ofliquid biopsy in tumor early screening, and other novel molecular diagnosis technologyin clinical application exploration,and probeinto the feasibility and future business modelof new technologies and applications.
Forum A
Tumor Early Screening and Biopsy Liquid Forum
Session 1: Development practices of frontier technology in early screening of tumor
1. Layout of R&D strategy and registration of tumor early screening products
2. New automated nucleic acid extraction and Library Preparation technology
3. Progress in methodological and comparative research on early biopsy of tumor screening
4. A high-quality extraction strategy for free DNA
5. Innovative targeted sequencing capture technologies to improve sequencing accuracy
Case Study: Experimental Design and Development of Liquid Biopsy Products with Digital PCR
Session 2: Technology ExplorationBased on tumor early screening biomarkers
6. Amplification Optimization and Innovation of DNA Methylation Sequencing Technology
7. A super-sensitive flow detection technique for the study of exosomes
8. Progress in the development of exosome fluid biopsy
9. progress in detection of circular RNA biomarkers
Forum B
Novel Clinical Molecular Diagnostics Forum
Session 1: Novel MDx development and application
1. Optimization of real-time PCR technology for detecting microbial variant subtypes
2. Development of molecular diagnostics for isothermal amplification PCR under Crispr Technology
Application of Flight Mass Spectrometry in Clinical Personalized Medicine
3. Advanced Practice of Microfluidic Chip POCT Technology Development
4. Application of Single Cell Sequencing Technology in Medical Detection
Session 2: Application Exploration for immunotherapy testing and tumor prognosis monitoring
5. Application of AI Big Data for Gene Detection in Tumor Immunotherapy
6. Clinical development and practice of NGS liquid biopsy for tumor immunotherapy Companion Diagnosis
7. Preliminary Exploration of Nanopore Sequencing Technology in Clinical Precision Medicine
8. Extended Application and Evaluation Strategy of Liquid Biopsy in Tumor Postoperative Intervention
Forum C
Molecular Diagnostics Regulatory Affairs and Market Access Forum
Session 1: Regulation and registration of molecular diagnostic products
1. The latest standards and trends in the performance evaluation methods of molecular diagnostic testing systems in 2019
2. Industry Consensus and Specification Analysis of NGS - TMB Companion Diagnostics
3. Performance Evaluation Standards and Leading Applications ofMolecular Diagnostic Materials
4. Standard Specification for Clinical Verification and Data Quality Inspection of Molecular Diagnostic Products
5. Case Study: Clinical Trial Design of Molecular Diagnostic Products
Session 2: Policies and Standards under NGS Technology
6. Standard Construction and Evaluation of NGS Tumor Detection panel
7. NGS clinical standards and quality control requirements
8. Case Study: Performance Verification and Quality Control of ctDNA-NGS Panel for Liquid Biopsy
9. Quality Control and Standardization Paradigm for Next-Generation Sequencing Data
Session 3: Business Model Exploration for Molecular Diagnosis and Gene Detection
10. Commercial Exploration of Gene Testing in Third Party Insurance Payment
11. Panel Discussion: Commercial implementation of Early Screening Liquid Biopsy Products for Tumors
12. Panel Discussion: Business Model and Pricing Access Strategy for Personalized Medicine in Future Molecular Diagnosis
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