Request for information: RNA-based fast fusion gene screening 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. The Laboratory of Genetics is seeking for an RNA-based fast fusion gene screening test for leukemia diagnostics. The test should be compatible with laboratory’s existing instruments. The annual number of fusion gene screening tests performed is 150. We ask companies interested in this procurement to answers to the questions listed in this request for information: 1) Is the test kit CE-IVD marked (IVDR)? If not, does the test kit have a plan for getting a CE-IVD mark according to EU IVDR regulation? 2) Which sample materials are suitable? 3) Which RNA extraction method is recommended? 4) Are the automatic extraction methods (Maxwell, QIAsymphony) suitable for test? 5) If the test kit is CE-IVD marked, is it determined which RNA extraction method should be used? 6) How much RNA is needed to perform the test? 7) Does the test kit contain reagents for reverse transcription reaction? - If not, does the test kit manufacturer have a separate kit for RT reaction? 8) If the test kit is CE-IVD marked, is it determined which reverse transcription method should be used for cDNA synthesis? 9) Does the test kit cover the most common fusions (at least PML, CBFB, KMT2A, BCR::ABL1, ETV6, MLLT10, RUNX1) in hematological samples ? 10) How many gene fusions and breakpoints does the test identify? List all gene fusions and breakpoints the test identifies. 11) Does the use of the test kit require any specific instruments? 12) Is the test kit compatible with QuantStudio 5 and 6 instruments? 13) How many samples can be examined in one run? 14) How long does it take to perform the test, including the analysis of results, for one sample? 15) How is the integrity of RNA and functionality of PCR verified/controlled? 16) Is the result qualitative or quantitative? 17) Has the manufacturer set a threshold for positive result? 18) Does the test kit contain positive and negative control? 19) What are the sensitivity and specificity of the test? 20) For how many samples does the test kit contain reagents? 21) In which temperature should the reagents be stored? 22) Is there an analysis program available for analysis of the results? Is the analysis program available free of charge? 23) Is the software in a cloud service or can it be installed in the user's own closed operating environment? 24) Is the manual available electronically? 25) What is the approximate price for testing one sample? The response to this request information should include description of fusion 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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