PMDA Perspectives on Oncology Panel. REIKO YANAGIHARA, Ph.D. Office of In Vitro Diagnostics PMDA

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1 15th DIA Japan Annual Meeting 2018 Promoting Better Collaboration to Drive Global Health and Innovation in an Era of Medical and Scientific Transformation November 11-13, 2018 Tokyo Big Sight PMDA Perspectives on Oncology Panel REIKO YANAGIHARA, Ph.D. Office of In Vitro Diagnostics PMDA

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to DIA, its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. DIA and the DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Page 2

3 Contents Regulatory Status of Oncology Panel in Cancer Genome Medicine in Japan Regulatory Perspectives on Oncology Panel CDx vs Comprehensive Genomic Profiling Test Page 3

4 Regulatory Status of Oncology Panel in Cancer Genome Medicine in Japan

5 Process Sheet for Cancer Genome Medicine Roundtable Consortium on the Promotion of Cancer Genomic Medicine FY2017 FY2018 FY2019 Core Hospitals Key Concept Requirement for facility Selection Guidance development Expansion of hospitals Oncology Panel Approval & Coverage by NHIS Consideration of panel testing under advanced medical care Arrangement for advanced medical care Implementation of advanced medical care using oncology panel panel testing under NHIS New advanced medical care Approval of Oncology Panel ASAP Discussion for implementation of WGS C-CAT Program for an Integrated DB of Clinical and Genomic Info Proto-typing Arrangement for Center for Cancer Genomics and Advanced Therapies (C-CAT) set-up Data accumulation Establishment of C-CAT Preparation for whole genome sequencing C-CAT WGS R&D Strategic promotion of Research and Development

6 Framework of Cancer Genome Medicine in Japan CGP by Oncology Panel 11 Core Hospitals for cancer genome profiling for medicine 135 Cooperative Hospitals Draft Report Evaluation by Expert Panel -clinical evidence of variants -available therapies Final Report Primary Care Physician Page 6

7 Implementation of Oncology Panel in Japanese Medical Setting DNA sequencing Oncology Panel DNA sequencer Variant call GeneX: c.2611c>t GeneY: c.1652a>g GeneZ:... Bioinformatics Pipeline Annotation Software SNV, Ins/Del, CNV,SV DB Draft Report GeneA:L858R GeneB: amplification Clinical Specimen Primary Care Physician Patient GeneA: #:.. SNV: xxxx.. GeneB: Indel: xxxx Final Report Interpretation by Page Expert 7 Panel

8 Oncology Panel as a IVD Medical Device IVD Medical Device DNA sequencing Variant call Annotation DB Oncology Panel GeneX: c.2611c>t GeneY: c.1652a>g GeneZ:... Bioinformatics Pipeline Software SNV, Ins/Del, CNV,SV DNA sequencer Draft Report GeneA:L858R GeneB: amplification Clinical Specimen Physician Patient GeneA: #: SNV: xxxx... GeneB: Indel: xxxx Final Report Interpretation by Page Expert 8 Panel

9 Promotion of Cancer Genome Medicine using Approved Oncology Panel Center for Cancer Genomics and Advanced Therapeutics: C-CAT Modified from Certified Labs for genomic testing specimens report Core hospital Sequence Data Clinical info cancer genomics info repository Analysis using AI Secondary use Development of Therapies, Dx system, and new BMs Expert Panel Cooperative Hospitals CKDB report Knowledge DB Maximize treatment opportunity in collaboration with core and associated hospitals, Pharmaceutical companies, Page 9 government

10 Regulatory Perspectives on Oncology Panel

11 Review Policies on conventional in vitro diagnostic MD Proposed IVD Medical Device is reviewed on the following aspects: Analytical Performance Clinical Performance Clinical Utility Page 11

12 Review Policies on NGS-based Oncology Panel Clinical Performance Expert Panel Design of Panel Content Analytical Performance Identification of possible driver genes Reference Database: Public DB: specified Proprietary DB: specified, DB procedures and operations are reviewed. Critical procedures to identify the clinically significant variants are subjected to the approved matter. Clinical Utility is expected to be established through implementation of the approved or advanced medical care-covered oncology panel and accumulation of genomic and clinical data in CKDB.

13 Analytical Performance Validation characteristics to be evaluated: Accuracy, Precision(repeatability, intermediate precision), specificity, Detection Limit Potentially interfering materials Representative validation approach: Validation sample set should cover the variant categories (SNVs, indels, and others) that NGS panel intended to detect. Scientific justification of representative set of variants are required. Page 13

14 Analytical Performance: Points to consider and Challenges Accuracy By comparison to an orthogonal method Test performance across tumor tissue types Challenges: Availability of the validated orthogonal method other than approved CDx in Japan Page 14

15 BRACAnalysis CDx Reference Database Comprehensive Genomic Profiling Test Ref DB Proprietary DB Public DB and proprietary DB What is reviewed? DB procedures and operations Variant interpretation Requirement and training for personnel involved in interpretation process.. etc. Procedures of variant interpretation using public and proprietary DB Procedures and operations of proprietary DB Requirement and training for personnel involved in interpretation process.. etc. Approved Matters DB procedures and operations Criteria of variant classification Variant classification procedure Variant re-classification criteria and procedure Procedures of variant interpretation using public and proprietary DB Procedures and operations of proprietary DB Approval conditions QMS inspection Variant classification operations following the approved SOP Annual report on: Newly identified variant Reclassification of variant Should be decided taking into consideration of: Transparency and public accessibility of public DB Clinical performance of panel is Page 15 dependent on Expert Panel

16 CDx vs CGP Test

17 Analytical performance Clinical performance Clinical Utility Summary CDx In principle, evaluation for each specific BM Representative validation approach is possible in some cases. Evaluated by -clinical study of the corresponding TP or -concordance study with the approved CDx Established in the major efficacy trials of TP Comprehensive Genomic Profiling Test Representative validation approach is possible, if justified. Established by expert panel Evaluated on whether it can appropriately provide necessary variant info for the expert panel to consider the best possible treatment for a patient. Expected to be established through the implementation of oncology panel into clinical setting Page 17

18 Summary CGP test is reviewed on whether analytical report produced by the proposed MD could serve necessary information for expert panels to consider treatment possibilities for patients. Design of Panel Content Analytical Performance Detectability for possible driver genes Expert Panel Clinical Performance Reference Database: Specified DB procedures and operations are reviewed for proprietary DB. Critical procedures to identify the clinically significant variants are subjected to the approved matter. 2018/7/26 SCRUM-Japan 成果報告会 Page 18

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