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The Special Non-Invasive Advances
in Fetal and Neonatal Evaluation Network

Outline and Objectives

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Project Outline

The SAFE Network started on 1 March 2004, and is set to run for a period of 5 years. It is sponsored under the EU Framework 6 programme to 12 Million Euros and has 50 partners from 19 countries currently participating. It is envisaged that collaborations may also be established with additional designated parties sharing a common interest in this field, who would become SAFE Associates. SAFE aims to lay the foundations for European advances in NIPD and NS. One of the reasons for the setting up the network is that relevant knowledge is dispersed across many disciplines, including molecular biology, medical genetics, bioinformatics, social justice, and ethical studies. SAFE brings together leading experts from the key disciplines in a programme designed to achieve intellectual and practical integration with a view to enhance the efficacy of NIPD and NS for genetic disorders within and beyond the European Community.

Project Objectives

The key objectives of the project are to:

Unite the leading European groups in the field.

Exploit novel tools for the enrichment and identification of fetal cells in maternal blood.

Coordinate currently fragmented efforts for identification of fetal cells in maternal blood samples, to develop tools for fetal cell isolation and subsequent diagnosis of genetic disorders.

Coordinate efforts for accurate identification and measurement of fetal DNA and RNA extracted from maternal blood samples in order to establish rapid and simple prenatal diagnosis of genetic disorders.

Standardise current protocols, such as that used for the non-invasive detection of the fetal RhD type which relies on identification of the paternal markers in cell free circulatory fetal DNA within maternal plasma and to determine the efficacy of this technology in large multi-centre clinical studies.

Assess the suitability of using cell free circulatory fetal DNA as a screening tool to determine pregnancies at risk for heterozygous Mendelian genetic disorders, such as the hemoglobinopathies prevalent in large proportions of the European population.

Standardise and ascertain the screening potential of cell free circulatory fetal nucleic acids (DNA & RNA) as predictive markers for fetal anomalies or pregnancy related disorders (such as preeclampsia and preterm labour).

Explore new and emerging technologies in depth with respect to their potential for NIPD of common chromosome disorders such as Trisomy 21, 13, 18 and Sex Chromosome Aneuploidies.

Gather key socio-economic data relevant to the scientific activities in relation to their introduction in clinical practice.

Involve interaction with psycho-social and ethical experts to guide direction of research and to establish public awareness, concerns and needs regarding the clinical application of such new diagnostic and screening measures.

Provide a resource of expertise and excellence to other relevant Networks of Excellence and Integrated Projects in the health, life sciences, nanotechnology and other thematic areas and to national programmes, enabling access to visionary long term research and intellectual property, and rapid problem solving under agreed commercial terms.

To promote responsible research and respect the fundamental ethical principles of the European Union as outlined in the Charter of Fundamental Rights of the European Union (2000/C 364/01). In particular SAFE upholds Article 3, the right to the integrity of the person and Article 8, protection of personal data

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GA Tarragona Photo

SAFE partners, General Assembly, Tarragona, Spain, February 2006