Gen&Tiss is an External Quality Assessment (EQA) program with a core focus on molecular genetic tests on tumor tissue in France.

Within the current standard practice of using paraffin-fixed material, the aim is to evaluate all stages of molecular genetic examinations involving the organization of the platform activities between pathology and molecular genetics.

The group takes into account three pillars of this quality control: Pathology (Association Française d’Assurance Qualité en Anatomie et Cytologie Pathologiques, AFAQAP), molecular biology (Groupe Francophone de Cytogénomique Oncologique, GFCO) and Quality Management (Catholic University of Louvain). The external laboratories involved in the validation of samples sent (Nijmegen, UMC St Radboud and Institut Curie). The steering committee is composed by 14 platforms involved in the molecular screening in France.

This program was designed to ensure uniform quality throughout the France and allows a national inter-laboratory comparison. It caters for all structures engaged in routine molecular genetic tests of cancers.

As part of the ISO 15189 certification, the Gen&Tiss program enables laboratories to participate in a compulsory external quality control program in order to achieve accreditation.

This national quality control program was supported by the Institut National du Cancer, French Cancer Institut (INCa) in 2012 and 2013. Now Gen&Tiss is supported by two professional associations: AFAQAP and GFCO.

The Gen&Tiss Activities

In 2015, we have extensive activities in Molecular analysis and genotyping of:

– KRAS as a predictive marker of metastatic colorectal cancer. Other optional markers for assessment include: BRAF, NRAS, MSI, PIK3CA
– EGFR as a predictive marker of lung adenocarcinoma. Other optional markers for assessment include: KRAS, BRAF, PIK3CA, ERBB2.
– BRAF as a predictive marker of melanoma. Other optional markers for assessment include: NRAS and KIT.

Participation in this program may be valued as part of an accreditation process.