Standardisation of pre-analytical and analytical procedures for in vitro diagnostics in personalised medicine

Provide pan-European quality assurance schemes and guidelines for pre-analytical procedures - such as sample collection, handling, transportation, processing and storing of clinical samples - and/or harmonisation and quality assurance of diagnostic practice.

The proposal should contribute to accreditation and certification, and participate in standardization activities at European level. Interaction with the European Metrology Programme for Innovation and Research (EMPIR) should be considered as appropriate. Outcomes could be coordination of validation studies, assessment of the results of method validations, training, counselling, quality procedures and guidelines.

Involvement of industry, including SMEs, and organizations for standardisation is expected.

The Commission considers that a proposal requesting a contribution from the EU of around EUR 2 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Standards are part of the knowledge economy that facilitate innovation and the adoption of new technologies. They are key elements of the competitiveness of European industry. They can improve safety and performance of products and services. Patients would benefit from the standardisation of in vitro diagnostic practice.

Progress in medical diagnostics is limited by insufficient guidelines for pre-analytical procedures and diagnostic services. The accuracy of measured values may be hampered by deficiencies of pre-analytical steps (sample collection, handling, etc.) and poor harmonisation and quality assurance of diagnostic practice (not all diagnostic laboratories are even accredited ISO15189).

• Harmonisation and quality assurance of in vitro ""diagnostic"" procedures for disease diagnosis, patient stratification and/or prognosis of disease outcome leading to improved clinical decisions and health outcomes for the benefits of patients.
• Contribution to the sustainability of health care systems by reducing the number of diagnostic mistakes.
• Growth and benefit to the European diagnostics industry, in particular SMEs.