EUROPEAN TELEMATIC OPEN TENDER FOR THE SUPPLY IN THREE-YEAR ADMINISTRATION OF REAGENTS INTENDED FOR MOLECULAR INVESTIGATIONS FOR NGS ANALYSIS, DIVIDED INTO N. 2 LOTS
Supply in three-year administration of reagents for molecular investigations based on NGS sequencing technology, for the analysis of fusion transcripts, mutations (SNP, INDEL) and CNV ofThe supply must include:
• Reagents for the preparation of massive parallel sequencing libraries (or NGS) for the execution of molecular tests for the identification of mutations in multigenic panels associated with onco-hematological diseases;
• Design, Development and Validation of custom multigenic panels for massive parallel sequencing (or NGS);
• Automatic raw data analysis software installable on multiple devices and with the creation of an unlimited number of users;
• Additional software licenses to support the interpretation of NGS data;
• Quality analyzer of the fragments of genomic libraries and reagents necessary for use;
• The company must provide technical assistance and specialist support;
• The company must bear the costs of interfacing the analysis software with the laboratory LIS.
Supply in three-year administration of reagents for molecular investigations based on NGS sequencing technology, for the determination of the presence or absence of clonality and hypermuteThe products applied for must have the following general minimum characteristics:
• You must have positive clonality and negative controls included in each kit;
• The system must allow the construction of libraries of DNA fragments with PCR-based method (without the need for genomic DNA fragmentation and centrifugation) and include indexing so that these can be sequenced in the same reaction (sample pool);
• Possibility to combine the analysis of all clonality markers in a single sequencing run;
• The system must be compatible with next-generation sequencing (NGS) on the Illumina MiSeqDx platform;
• Diagnostic software able to generate graphs and descriptive tables of the identified clonal rearrangements;
• Possibility to use the same clonality determination kits also for follow-up analysis and evaluation of Minimal Residual Disease (MMR);
• Possibility of additional "stand-alone" software for follow-up analysis and evaluation of Minimal Residual Disease (MMR);
• The system and software must have CE-IVD certification with specific indication for diagnostic use.