Finlandia - Reattivi da laboratorio - RICHIESTA DI INFORMAZIONI: test CNV basati su MLPA per BRCA1/BRCA2

With this request for information (RFI), HUS Group launches a market consultation to prepare a forthcoming procurement. The aim of this RFI is to find suppliers operating in this field of business, get information of the solutions available in the market, and inform our plans and requirements for the forthcoming procurement. DESCRIPTION OF THE SUBJECT OF THE REQUEST FOR INFORMATION HUSLAB Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is a SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic and follow-up genetic testing services to all patients at Helsinki University Hospital area. The services include analysis of both constitutional samples and malignancies. This Request for Information is released for preliminary evaluation and market research for copy number variations (CNVs) in BRCA1 and BRCA2 genes by MLPA (Multiplex Ligation-dependent Probe Amplification). INSTRUCTIONS FOR ANSWERING Responses to this request for information must be submitted in English or Finnish by email to kilpailutus.diagnostiikka@hus.fi no later than 14 April 2026. The subject line of the email must include: HUS 589-2025 MLPA-Based CNV Testing for BRCA1/BRCA2. The response must include all the information requested below in sections 1-8. The respondent is also requested to provide a contact person and an email address for potential bilateral market dialogue and additional information requests from the contracting authority. Respondents may also attach any available brochures related to the proposed products and services. Requirements to be addressed in the RFI Response: 1. Technology and Performance 1.1 Performance across different sample types (whole blood, FFPE), including examples of analytical accuracy, sensitivity, and limits of detection. 1.2 How are detection limits determined for different sample matrices? 2. Workflow and Capacity 2.1 Turnaround time for the laboratory work. 2.2 How many samples can be processed simultaneously? 3. Validation and References 3.1 Available validation data. 3.2 User references. 4. Reagent Composition 4.1 Complete list of required components. 4.2 Available kit sizes. 4.3 Availability of ready-to-use controls for assays? 4.4 Availability and supply reliability. 4.5 CE-IVD marking. 5. Software and Data Management 5.1 Required software. 5.2 Required IT systems for instrument operation and data analysis. Are these included in the total price? 5.3 How is the analysis performed? 5.4 Supported file formats. 6. Support 6.1 Availability of (local) technical support. 7. Cost Estimate 7.1 Estimated costs for kits/consumables, and the maintenance. 8. Product Descriptions and Delivery Time 8.1 Descriptions of the proposed products. 8.2 An estimation of the delivery time of the proposed products.