Guidelines

The IPTS, ESTO and EuroGentest report on PGD in Europe has been released and again highlights the pressing need for EuroGentest’s harmonization work. Commissioned in March 2005, the report surveyed 53 centers across Europe and highlights a number of issues for concern – quality assurance was found to be inconsistent and accreditation needs improving, genetic counselling is not being performed consistently, considerable work is needed to meet the requirements of the EU Human Tissue and Cells Directive and systematic longterm follow-up is only being carried out in one centre in Belgium. Lastly the regulatory situation differs in member states leading to large numbers of patients having to travel to Spain, Cyprus, Belgium and the Czech Republic for testing.

Download the executive summary

Download the report

OECD Guidelines for Quality Assurance in Molecular Genetic Testing

Now available on our website in English and French

New OECD Guidelines for Quality Assurance in Molecular Genetic Testing will set a framework for genetic testing services. EuroGentest members have been heavily involved in the preparation of these guidelines as well as other guidelines to harmonize the practice of gentetic testing. EuroGentest is organising a series of roadshows presentations at national level to explain to stakeholders the implications of the new guidelines and suggested pathways to implementation. The first is scheduled for Poland in September.

http://www.oecd.org/

Guidelines on counselling (draft)

As patients' understanding of the results and consequences of the test is an integral part of genetic testing, EuroGentest also aims at improving the quality of genetic counselling services associated with genetic testing, across Europe. One of the goals is to establish recommendations for genetic counselling in connection with different testing situations.

• Draft of recommendations for genetic counselling
  (WP3.1 - Released: 1st June 2007) ( pdf version)
• Draft of recommendations for genetic counselling (old version)
  (WP3.1 - Released: 6th November 2006)
• Summary of the International Guidelines for Genetic Counselling
  (May 2006) ( pdf version)

Best Practice Guidelines for Molecular Genetic Testing

Cytogenetic Guidelines and Quality Assurance

Guidelines and standards related to quality management

Biochemical genetics

• Theroretical aspect of QC in IEM and Method validation
• Control of Accuracy and Precision
• Amino Acid Analysis Recommendations
• Biomed 2 Recommendations
• Polymorphonuclear Leucocyte Preparation
• Mixed Leucocyte Preparation