The Health 2030 Genome Center Receives ISO 15189 Accreditation
The accreditation granted to the Health 2030 Genome Center is unique among Swiss public institutions in its broad focus on methods appropriate for a wide range of diseases rather than one or a few specific diseases.
The Health 2030 Genome Center announced today that it had received ISO 15189:2013 certification for medical laboratories from the Swiss Accreditation Society for its human whole-genome sequencing, whole-exome sequencing, and transcriptome RNA sequencing assays. This certification allows the Genome Center to perform these assays on nucleic acid samples provided by hospitals, clinics, research institutions, and research organizations.
The accreditation covers DNA and RNA library preparation and sequencing. The resulting data can be used to identify genomic sequence variants and alterations in gene expression at the RNA level.
According to Genome Center Director Manolis Dermitzakis, Professor at the University of Geneva, “A unique feature of our accreditation is that, rather than focusing on one or a few narrowly defined disease phenotypes, it covers a range of sequencing-based DNA and RNA analysis methods, the data from which can be used for a very wide range of clinical diagnoses. Furthermore, all of the data we generate with these assays are clinical-grade, even for samples from clinical research projects. This means that, when appropriate, the data from research projects can be used to inform clinical decisions.”
EPFL Professor Didier Trono, Chairman of the Health 2030 Genome Center Strategic Committee, added, “This is a major achievement, considering that no other platform of the kind is accredited in such a broad way in Switzerland. Advanced genomics represents an essential pillar of precision medicine, nothing less than what the Swiss population is entitled to.”