Sequencing Multiplex (SeqPlexing), technological partner of Sabartech-Overgenes, has managed to certify the analysis of the i3 test by massive sequencing or NGS through the Spanish Medicines Agency (AEMPS) to obtain the CE-IVD Mark.

The CE-IVD Mark is a certificate granted by the European Union that guarantees the quality of a medical device for in vitro diagnostics and its correct functioning, i.e., it guarantees its use by any European analysis laboratory. The i3 test becomes the first preventive genetic test with CE-IVD Mark, which will allow its commercialization in KIT format for its analysis by NGS.

Seqplexing has developed the Mutation Detector Software for automatic processing of data obtained from i3 analysis by NGS.

Overgenes (July 2019) i3 genetic test obtains CE-IVD marking Retrieved from: https://overgenes.com/2019/07/01/el-test-genetico-i3-obtiene-el-marcado-ce-ivd/