The i3 genetic test obtains the CE-IVD mark.

Sequencing Multiplex (SeqPlexing), technological partner of Sabartech-Overgenes, has managed to certify the analysis of the i3 test by Next Generation Sequencing (NGS) analysis through the Spanish Regulatory Agency of Medicines (AEMPS) to obtain the CE-IVD Marking.

The CE-IVD Marking is a quality certificate that complies with European Union regulations that guarantee the quality of a Medical Devices for in vitro diagnosis and its correct operation, and allows its use through any European analysis laboratories. The i3 test becomes the first preventive genetic test with CE-IVD Marking, which will allow its commercialization in KiT format for NGS analysis (MySeq Illumina Platform).

The kit is complemented with the Mutation Detector Software for the automatic processing of the data obtained from the i3 NGS analysis and the software for automatic results report generation.