Request for information: MGMT methylation test

This is not a call for tenders and does not obligate the Acquisition Unit of the Joint Authority of the Helsinki and Uusimaa Hospital District for any actions. The responses to this information request do not obligate the acquisition unit to any service acquisitions. Responding to this request for information is not a prerequisite for participation in the future procurement. Interested parties will not be prejudiced by any failure to participate in this preliminary market consultation. HUS will not charge, nor reward any costs of the market consultation. HUSLAB 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 University Hospital area. The services include analysis of both constitutional samples and malignancies. The laboratory provides sequencing services mainly using multiple diagnostic laboratory processes. Currently, MGMT methylation test in brain tumors has been used for years in our in house laboratory processes. Due to the upcoming process change and the IVDR regulation, the laboratory is looking for a ready-to-use product based on DNA methylation markers suitable for determining the degree of methylation of the promoter region of the MGMT gene. The estimated number of studies per year would be around 200. This Request for Information is released for preliminary evaluation and market research for potential replacement solutions for methylation of the promoter region of the MGMT gene. The product should be applicable to the equipment in the laboratory. The main objects of this information request are: 1) Which sample materials are suitable for research? Is it suitable for FFPE samples? 2) Is it possible to use an automated DNA isolation method (Maxwell/Qiasymphony) for the research? 3) Does the kit have a CE-IVD mark (IVDR regulation requirements)? 4) Does the kit have a plan to obtain the CE-IVD mark (IVDR regulation requirements)? 5) How many methylation markers are included in the kit? 6) What equipment does the kit require? List what. 7) What method is the research based on? Is it suitable for QuantStudio 5 or 6, Rotor-Gene? 8) Is the result quantitative? 9) Is there a threshold value set by the manufacturer for a positive result? 10) What is the sensitivity and accuracy of the method? 11) How many samples can be examined with one kit? 12) How many samples can be made in one run? 13) How long does the laboratory work + analysis of one sample take? 14) Does the kit include a positive and negative control? 15) Does the kit include reagents for the bisulfite conversion reaction? If not, does the manufacturer have a separate putty for this. 16) If the kit has a CE-IVD marking, is it specified in the kit which method should be used for bisulfite conversion? 17) Is there an analysis software available for the kit? 18) Is the analysis software free of charge? 19) Is the software in a cloud service or can it be installed in the user's own closed operating environment? 20) Is the manual available electronically? 21) What is the price estimate for one sample? 22) Has the method been validated in prospective clinical drug trials? List where. The response to this request information should include description of MGMT methylation test offered. An estimation of the turn-around-time and cost of service should also be included. All information obtained will be held confidential. RESPONSES TO THE REQUEST FOR INFORMATION The response to this request for information should include descriptions to the above questions. Responses are requested to be submitted latest on 21.6.2024 at 12.00 (UTC +2) to kilpailutus.laboratorio@hus.fi

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