Companion diagnostics and the IVD Directive 98/79/EC + revision

Transcription

1 Companion diagnostics and the IVD Directive 98/79/EC + revision European Perspectives in Personalised Medicine Square-Brussels Meeting Centre Brussels, Belgium May 2011 Dr. Anne Van Nerom Rue Juliette Wytsmanstraat Brussels Belgium T F info@wiv-isp.be

2 Medical Device Directives * Active Implantable Medical Devices (AIMDD) - Directive 90/385/EEC * Medical Devices (MDD) - Directive 93/42/EEC * In vitro Diagnostic Medical Devices (IVDD) - Directive 98/79/EC 2

3 Definition of an IVD any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body for the purpose of providing information * concerning a physiological or pathological state * concerning a congenital abnormality * to determine the safety and compatibility with potential recipients * to monitor therapeutic measures 3

4 Drug treatment responders to drug treatment non-responders adverse drug reaction 4

5 Companion diagnostic selection stratification + selection responders to drug treatment non-responders adverse drug reaction 5

6 Companion diagnostic responders to drug treatment non-responders selection stratification negative selection adverse drug reaction 6

7 Companion diagnostics Stratification of population/selection of patient * selection of responders * avoid non-responders * identify patients at risk for toxicity * avoid adverse drug event * reduce 'trial and error' treatment * risk-benefit * cost-benefit 7

8 Definition of an IVD any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body for the purpose of providing information * concerning a physiological or pathological state * concerning a congenital abnormality * to determine the safety and compatibility with potential recipients * to monitor therapeutic measures 8

9 Definitions within the IVD Directive manufacturer responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person of on his behalf intended purpose the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions for use and/or in promotional materials 9

10 Essential Requirements Legal harmonisation Guarantee safety * risks/benefit Guarantee performance and characteristics * achieve performances specified by the manufacturer Design and manufacturing requirements * chemical and physical properties * infection and microbial contamination * manufacturing and environmental properties * users information supplied by the manufacturer *... 10

11 Technical harmonisation Harmonised standards (EN) * voluntary * presumption of conformity Common Technical Specifications * required to comply * if duly justified reason: at least equivalent * presumption of conformity 11

12 Marketing companion diagnostics * Traditional IVD industry * Pharmaceutical industry * Spin-offs of universities * Health-institution laboratories "in house testing" - produced and used within a health-institution laboratory - without transfer to another legal entity * Commercial laboratories "testing services" - providing analysis and results - devices are not put on the market 12

13 Classification of IVD devices Conformity assessment Today * General IVD * Self-certification by the manufacturer Except when listed in Annex II HLA tissue groups: DR, A, B tumor marker: PSA HIV 1 en 2, HTLV I and II, hepatitis B, C, D Future: revision of the IVD Directive * Rule-based classification * Based on model Global Harmonization Task Force: GHTF/N045:2008 * Class C High Individual Risk and/or Moderate Public Health Risk * Conformity assessment by Notified Body 13

14 Drug Diagnostic Co-Development Diagnostics Marker Assay Validation Analytical Validation Clinical Validation Approved diagnostic kit Therapeutics Basic Research Prototype Design or Discovery Preclinical development Clinical phase I II III FDA/EMA approval launch Adaptation of Drug Diagnostic Co-Development Concept Paper", FDA,

15 Flexibility needed Selection of good candidates Exclusion of bad candidates Approved diagnostic kit Therapeutics Basic Research Prototype Design or Discovery Preclinical development Clinical phase I II III FDA/EMA approval launch Selecting biomarkers 15

16 Developments * Co-development with new drug ~ biomarker - founded selection of biomarker - extrapolation towards human model - evidence of clinical utility * Failure clinical trial ~ trial response variability * 'On the shelf' ~ eliminated due to response variability - selection of biomarker a posteriori * 'Generic' companion diagnostics - comparison with existing companion diagnostic 16

17 Needs for Companion diagnostics * Provide a clear definition - critical link with specific drug treatment * Request evidence of clinical utility - achieve performances specified by the manufacturer - conformity assessment Class C - accreditation or equivalent for 'in house testing' * Identify validated combinations - listing of approved drugs - listing of notified IVD or 'in house tests' - available for Authorities and users 17

18 Thank you 18 Dr. Anne Van Nerom Coordinator Belgian Competent Authority for in vitro diagnostic Medical Devices Scientific Institute for Public Health (WIV-ISP) J. Wytsmanstraat 14 B-1050 Brussels