Large Cancer Panel Test

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 Important Information Concerning Lot B of the Procurement Procedure The Contracting Authority has decided to discontinue Lot B of the procurement procedure.During the procurement procedure, it became apparent that substantial amendments are required to the subject matter of Lot B and the related procurement documents. As these amendments cannot be implemented through a corrigendum without jeopardising the equal and non-discriminatory treatment of tenderers, the Contracting Authority has decided to discontinue Lot B.Lot B will be re-tendered through a separate procurement procedure. A new contract notice and new procurement documents for Lot B will be published separately.Please note that LOT A is still continuing the tendering process. - 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.Main features of the procedureThe procurement shall comply with the Act on Public Procurement and Concession Contracts (1397/2016, referred to as the Public Procurement Act). The procurement value exceeds the EU threshold value. The procedure shall be an open procedure as defined in section 32 of the Public Procurement Act. PROCESSING OF TENDERS The procedure shall include the following phases: Contracting entity (HUS Group) 1. Opens the tenders 2. Verifies the suitability of the tenderer (ESPD form and Call for tenders) 3. Checks that the tenders conform to the invitation to tender 4. Compares the tenders (POSSIBLE TEST USE) 5. Requests and checks certificates and reports on the suitability of the winning tenderer(s) 6. Makes a procurement decision and communicates it to all the tenderers 7. Concludes an agreement with the selected tenderer(s) LANGUAGE OF THE TENDERING PROCEDURE The procurement documents are available in English. If a tenderer needs the documents in another language, the tenderer shall be responsible for translation and liable for the associated costs. Tenders must be prepared in English. PARALLEL TENDERS Parallel tenders are not permitted. PARTIAL TENDERS Partial tenders are permitted as follows: The tenderer may submit tender for one or two lots. Tenderer may be awarded contracts for a maximum of two lots. ALTERNATIVE TENDERS Alternative tenders are not permitted. PROCUREMENT VOLUMES Any procurement volumes stated in the procurement documents are only estimates and therefore are not binding to the contracting entity. The contracting entity has no obligation to purchase any specific quantities. DIVIDING INTO LOTS The procurement agreement has been divided into lots. RESERVATION FOR SUSPENDING THE PROCUREMENT The contracting entity may suspend the procurement procedure in whole or in part for a real and justified reason (Article 125 of the Act on Public Procurement). APPLICATION OF THE IPI REGULATION AND THE MEASURE This procurement is subject to Regulation (EU) 2022/1031 of the European Parliament and of the Council (the International Procurement Instrument, IPI) as well as Commission Implementing Regulation (EU) 2025/1197. As required by the IPI measure, the contracting authority will exclude from the procurement procedure any tenderers originating from the People’s Republic of China. In addition, the contracting authority will apply the obligations laid down in Article 8 of the IPI Regulation to the suppliers selected in the tendering procedure. See Annex "Main Agreement". If a tenderer offers products of Chinese origin, they will be treated in the procurement procedure in the same way as products originating from any other country. Chinese products are therefore not excluded from the procurement procedure. However, if products of Chinese origin are selected for the contract and, as a result, more than 50% of the contract value would consist of Chinese products (calculated from the total contract value, not the number of items), the tenderer must commit to the pen-alty fee described in Annex "Main Agreement", amounting to 10–30% of the value of the agreement. As a rule, products offered cannot be replaced after the procurement decision has been made. The underlying principle of public procurement procedures is the finality of the tender (Public Procurement Act, Section 74, and case law). In addition, Section 136 of the Public Procurement Act stipulates that contracts may not be substantially modified (replacing offered products with different ones would be regarded as a substantial modification). ESTIMATED VALUE The total estimated value of the procurement (VAT 0%) is approximately EUR 5 200 000. This is an estimate and the contracting entity does not commit neither to the stated euro amounts and nor the consumption figures indicated in the invitation to tender. The final order quantities may be higher or lower than stated.