This is a request for information related to a market prospection concerning a study on screening for foetal developmental disorders, the first trimester, serum, i.e. S -Tr1Seul, KL 4548. The study determines the likelihood of fetal 21-trisomes (Down syndrome) and 18-trisomes (Edwards syndrome) in expectant mothers in Finland. In addition, the request for information concerns the study Coriongonadotropin-B subunit, human, free, from serum, i.e. S-hCG-B-V, KL 4235. The study is used for the diagnosis and monitoring of tumours, especially throphoblastic tumours and testicular cancer. Currently, the HUS Diagnostic Center has a self-made test, which is a combination of two commercial reagents to achieve sufficient sensitivity (<1 pmol/l). HUS Diagnostic Center has three Delfia Xpress System (Revvity) analyzers for screening foetal developmental disorders and a bump plate reader for Viktor Nivo (Revvity) S -hCG-B-V study. With this request for information, we want to map the market supply for these studies, i.e. the availability of reagents, consumables and maintenance services for existing equipment. We are also interested in hearing about alternative devices and solutions based on the reimbursement principle (the service would be paid according to the results). If you have any of the above products in your selection and are interested in participating in the market dialogue, please send a message to kilpailutus.tiimi@hus.fi with the subject line "HUS 845-2023 Information request: Monitoring of foetal developmental disorders and S-hCG-B-V". In this message, we ask you to tell us about the products and solutions in your portfolio and to answer the following questions (1-6): 1) Are there products suitable for the analytics described in your selection? 2) Does your Opinion apply to existing equipment in the HUS Diagnostic Centre (Delfia Xpress System/Viktor Nivo)? 3) Do you have any other equipment in your portfolio that would allow the requested analytics to be carried out? A brief description of the solution and maintenance organisation in your portfolio. 4) List of reagents and consumables required to perform the analytics described above. 5) Shelf life and storage conditions of reagents, pack sizes? 6) In accordance with the IVDR regulation, is the product in your assortment CE-IVD-marked or what is the manufacturer's plan for obtaining CE-IVDR-marking? We also ask you to attach product brochures or other appendices describing the products in question to the message. Please also provide the name of your contact person, who we can contact for a possible meeting, product presentation or additional questions. We would like to receive your reply as soon as possible, but no later than 3 p.m. on 21 November 2024. The Contracting Entity reserves the right to arrange a more detailed market dialogue with the registered parties at its discretion. This request for information does not constitute a contract notice, a prior information notice or a call for tenders and the publication of this notice does not constitute a call for tenders. Responding to a request for information is not a prerequisite for participating in a possible subsequent tendering procedure, and responding to a request for information does not affect the tenderer’s position in a possible tendering procedure. Participants in the market dialogue shall not be entitled to compensation for their participation. Responses given in the market dialogue shall not be binding on the respondent in any subsequent procurement. The market dialogue does not oblige the HUS Group to carry out the actual tendering and procurement. If the acquisition is carried out, it may also be different from what is stated in this market dialogue. The information gathered through the market dialogue will remain confidential and will only be used to plan the procurement.
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