Finlande - Test grand panel cancer pour le HUS Diagnostic Center

The HUS Group (also "the contracting entity", "the Client" or “HUS”) requests tenders for a large cancer panel test for HUS Diagnostic Center. The procurement includes also data analysis software for reporting clinically significant variants, copy number alterations and gene fusions. The software can be offered by the same provider as the large cancer panel test or from a partner company (offer as a group or appeal to a subcontractor's resources), but it needs to be included in the same tender. The software will be procured for the entire lifecycle of the assay. The procurement consist of gene panels and reagents (also "products") and data analysis software (also "services", e.g. information system provided as Software as a Service). Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki and Uusimaa Hospital District. The laboratory operates as a health institution capable of validating in-house developed tests as required by the CE-IVD regulation. The services include analysis of both constitutional samples and malignancies. The laboratory provides sequencing services mainly using local sequencing capacity (Illumina NovaSeq 6000, NovaSeq X Plus, Ion GeneStudio S5 Prime equipment). The large cancer panel test is intended for detection of small nucleotide variants (SNVs), indels, gene fusions, copy number variations (CNVs), microsatellite instability (MSI), homologous recombination deficiency (HRD), and tumor mutation burden (TMB) relevant for the genetic profiling of solid tumor samples and/or hematological malignancies as well as plasma samples for cfDNA analysis. Sequencing of the samples is carried out using Illumina NovaSeq sequencers (Illumina NovaSeq 6000 and NovaSeq X Plus). The number of cancer panel tests performed annually is estimated to be between 2500-3000. The procurement is divided into LOT A and LOT B: LOT A - This lot includes gene panel solutions for in-house NGS testing of solid tumors and hematological malignancies, including library preparation reagents, target enrichment reagents defining the panel content, panel-specific reagents, data analysis software, and instructions for use. Sequencing reagents, flow cells, sequencing instruments, and testing services are not included in this procurement. - This test is based on analysis of total nucleic acids (RNA and/or DNA) extracted from paraffin embedded specimens and/or fresh-frozen specimens - This lot includes an option for special gene panel and reagents for salivary gland tumors with data analysis software - This lot includes an an option for a custom gene panel and reagents with data analysis software - The HUS Group will decide separately on the use of the options LOT B - This lot includes gene panel solutions for in-house NGS testing of cell-free DNA, including library preparation reagents, target enrichment reagents defining the panel content, panel-specific reagents, data analysis software, and instructions for use. Sequencing reagents, flow cells, sequencing instruments, and testing services are not included in this procurement - This test is based on analysis of cell-free DNA from plasma samples NOTE: For LOT A, the tenderer may offer a catalog panel, a combination of catalog panels, or a custom solution to meet the DNA and RNA requirements. For hematological malignancies, only a panel for DNA is requested. Panel for salivary gland tumors and custom panel are requested as an option. NOTE: FOR LOT A and LOT B, the tender needs to include all the reagents required to perform the assay, including library preparation reagents, indexing adapters and target enrichment reagents (or equivalent). Nucleic acid extraction reagents, library quantification reagents and sequencer reagents are excluded from the tender. The subject of the procurement and its requirements are described in more detail in the call for tender and its appendices. The tenderer can submit a tender to either one or both of the LOTS A and LOT B. The tenderer can be awarded the contract to either one or both tendered lots. The contrcting entity selects one (1) supplier for each lot and will enter into an agreement with the winning supplier. The estimated start for the contract period is autumn-winter 2026. The contracting entity recieves a right to test use tendered panels and softwares after the deadline for receiving the tenders. The procurement volumes presented in the call for tenders are estimates, and the contract does not constitute a mandatory purchase obligation for the contrcting entity or an exclusive right for the supplier to provide the product.