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Advancing Fetal & Neonatal Evaluation: Non-Invasive Technologies.

Explore cutting-edge non-invasive prenatal diagnosis technologies in the SAFE project - integrating biomedical science, social sciences, and ethics to standardize protocols and spread excellence worldwide.

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Advancing Fetal & Neonatal Evaluation: Non-Invasive Technologies.

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  1. Special Non-Invasive Advances in Fetal and Neonatal Evaluation Network of Excellence Project Number: LSHB-CT-2004-503243

  2. Traditional Prenatal DiagnosisChromosome Disorders • Increased maternal age • Carrier of a structural rearrangement • Previous chromosome anomaly • Family history • Abnormal ultrasound scan or serum test results Warning Signs

  3. Traditional Prenatal DiagnosisInvasive Procedures Amniotic fluid: AmniocentesisChorionic villi & Fetal blood • Karyotyping- timeconsuming & labour- intensive • FISH • QF-PCR/MLPA • Microarrays

  4. 56 partners in 19 countries €12 million for 5 years 2004-2009

  5. Mission statement Implement routine non-invasive prenatal diagnosis and cost effective neonatal screening through the creation of long-term partnerships.

  6. SAFE Structure International Experts Advisory Board 7 WP leaders Integration SoE PM Steering Committee Integration Scientific WPs Social Sciences WPs WP1 WP5 Socio-economics WP2 WP6 SoE WP3 WP7 WP4

  7. Key ObjectivesBiomedical Science Science Integration/Unite leading European groups Co-ordinate research/Exploit novel tools/ Explore future technologies Standardise protocols Spreading of Excellence Social Science Integrated Research Pshyco-social aspects of new technologies Ethics Socio-economics Implementation Spreading of Excellence

  8. WP 1 Fetal Cells WP Leader: Sinuhe Hahn Basel, Switzerland New Antibodies ISET cell size / trophoblasts Telomere length

  9. WP 2 Automation WP Leader: William Clocksin Oxford, UK Automatic computer-based cell identification Evaluation existing scanning technology SMEs: Metasystems Chemscan PALM-laser IMSTAR Algorithm Resource Centre (ARC)

  10. WP 3 Nucleic Acids WP Leaders: Neil Avent / Ellen van der Schoot Bristol, UK Amsterdam, NL Free fetal DNA DNA extraction procedures RHD/SRY/DYS14 ff DNA Fragmentation/Microfluidics Epigenetics Free Fetal RNA/Transcriptomics/Proteomics Placental Biology Placental perfusion model Aptamers/Mabs to STBM-specific markers STBM proteomics/transcriptomics

  11. WP 4 New Technology WP Leader: Ciara O’Sullivan Tarragona, Spain Aptamers RNAs that recognise e.g Trophoblasts/ erythroblast-specific proteins Microfluidics Microsystem Capillary Electrophoresis New Technology Resource Centre (NTRC)

  12. WP 5 Psychosocial Evaluation WP Leader: Lucia Savadori Trento, Italy • Physicians: • making probability information meaningful to patients • strategy for patient communication • Pregnant women and their spouses/partners: • decisions on test selection • understanding medical messages on probability • Web-based training programme

  13. WP 6 Socio-economics WP Leader: Ala Szczepura Coventry, UK NIPD RhD implementation Questionnaire (Delphi) analysis Literature review Interviews - key stakeholders in partner countries Internet Forum Economic Modelling Simulation Tool for Policy makers Socio-economic evaluation protocols for any new non-invasive prenatal testing strategies for fetal RhD blood group status and other upcoming technologies

  14. Socio-economics within the context of SAFE • We examine socio-economic and health policy issues associated with the scientific advances • We help guide the direction of the scientific research into clinical practice Clinical Practice Science New technologies

  15. Prenatal Diagnostics Genetic Counselling Routine Tests Specific Tests New Technologies Home-testing Physician Laboratory

  16. HTA HTA is a systematic process by which the direct and indirect consequences of a particular technology are assessed; evaluating the safety clinical/technical effectiveness, cost-effectiveness, social, ethical and legal impact of technology Health Technology Assessment policy making imperative HTA is an essential bridge between basic research and the development and prudent application of health technology Assessment Tools Data collection/analysis/evaluation, Statistical studies, cost analysis, expert opinion, group analysis Interviews, surveys, literature review, Clinical Trials, Etc.

  17. Will SAFE technologies make it? • Not all technologies have potential to succeed in the market • Optimistic ideas of scientists and clinicians as clinical implementation is concerned can be greatly overestimated Budgets are Limited! Technologies are NOT!

  18. WP 7 Ethical aspects WP Leader: Theresa Marteau London, UK Develop ways of facilitating informed choices Attitudes and practices - fetal sexing in Europe - impact of NIPD for sex selection

  19. Integration and Spreading of Excellence • Exchange of • Personnel • Samples • Reagents • Techniques • Joint Research Program • Workshops, Conferences • Publications

  20. Discussion • Do you think technologies developed by SAFE will be acceptable for policymakers and clinicians? • What factors may contribute to the success of these technologies?

  21. For further information on the project please feel free to contact Professor Maj Hulten in Biological Sciences. M.Hulten@warwick.ac.uk and visit our website at www.safenoe.org

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